83_FR_3734 83 FR 3716 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2017

83 FR 3716 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2017

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

Federal Register Volume 83, Issue 18 (January 26, 2018)

Page Range3716-3730
FR Document2018-01475

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2017, relating to the Medicare and Medicaid programs and other programs administered by CMS.

Federal Register, Volume 83 Issue 18 (Friday, January 26, 2018) 
[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Notices]
[Pages 3716-3730]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01475]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9106-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--October Through December 2017

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 October through December 2017, 
relating to the Medicare and Medicaid programs and other programs 
administered by CMS.

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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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                  Addenda                                        Contact                           Phone No.
----------------------------------------------------------------------------------------------------------------
I. CMS Manual Instructions................  Ismael Torres....................................     (410) 786-1864
II. Regulation Documents Published in the   Terri Plumb......................................     (410) 786-4481
 Federal Register.
III. CMS Rulings..........................  Tiffany Lafferty.................................     (410) 786-7548
IV. Medicare National Coverage              Wanda Belle, MPA.................................     (410) 786-7491
 Determinations.
V. FDA-Approved Category B IDEs...........  John Manlove.....................................     (410) 786-6877
VI. Collections of Information............  William Parham...................................     (410) 786-4669
VII. Medicare-Approved Carotid Stent        Sarah Fulton, MHS................................     (410) 786-2749
 Facilities.
VIII. American College of Cardiology-       Sarah Fulton, MHS................................     (410) 786-2749
 National Cardiovascular Data Registry
 Sites.
IX. Medicare's Active Coverage-Related      JoAnna Baldwin, MS...............................     (410) 786-7205
 Guidance Documents.
X. One-time Notices Regarding National      JoAnna Baldwin, MS...............................     (410) 786-7205
 Coverage Provisions.
XI. National Oncologic Positron Emission    Stuart Caplan, RN, MAS...........................     (410) 786-8564
 Tomography Registry Sites.
XII. Medicare-Approved Ventricular Assist   Linda Gousis, JD.................................     (410) 786-8616
 Device (Destination Therapy) Facilities.
XIII. Medicare-Approved Lung Volume         Sarah Fulton, MHS................................     (410) 786-2749
 Reduction Surgery Facilities.
XIV. Medicare-Approved Bariatric Surgery    Sarah Fulton, MHS................................     (410) 786-2749
 Facilities.
XV. Fluorodeoxyglucose Positron Emission    Stuart Caplan, RN, MAS...........................     (410) 786-8564
 Tomography for Dementia Trials.
All Other Information.....................  Annette Brewer...................................     (410) 786-6580
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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.

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 website 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 website list provides more timely 
access for beneficiaries, providers, and suppliers. We also believe the 
website 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 
websites have listservs; that is, the public can subscribe and receive 
immediate notification of any updates to the website. These listservs 
avoid the need to check the website, as notification of updates is 
automatic and sent to the subscriber as they occur. If assessing a 
website 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 17, 2018.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P

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[FR Doc. 2018-01475 Filed 1-25-18; 8:45 am]
 BILLING CODE 4120-01-C

3716 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices panel meeting and the transition to one and resubmitted no later than 3 years to serve on the Panel under the meeting of the panel per year (81 FR after the original nomination submittal conditions described in this notice and 31941). to continue to be considered for further specified in the Charter. committee vacancies. CMS will consider • The hospital or hospital system II. Request for Nominations; Criteria for the nominations submitted in response name and address, or CAH name and Nominees to the notice published in the Federal address, as well as all Medicare hospital The Panel shall consist of a chair and Register on December 23, 2016, entitled and or Medicare CAH billing numbers up to 15 members who are full-time ‘‘Medicare Program; Renewal of the of the facility where the nominee is employees of hospitals, hospital Advisory Panel on Hospital Outpatient employed. systems, or other Medicare providers Payment and Solicitation of Future updates or changes to the that are subject to the OPPS. For Nominations to the Advisory Panel on panel nomination process may be supervision deliberations, the Panel Hospital Outpatient Payment’’ (81 FR published in the Federal Register or shall also include members that 94378), unless they are withdrawn or posted on the CMS Advisory Panel for represent the interests of Critical Access the nominees’ qualifications have Hospital Outpatient Payment website, Hospitals (CAHs), who advise the changed. Nominations will be referenced in section II, ‘‘Request for Centers for Medicare & Medicaid considered as vacancies occur. Nominations; Criteria for Nominees,’’ of Services (CMS) only regarding the level The Panel must be balanced in its this notice. of supervision for hospital outpatient membership in terms of the points of therapeutic services. (For purposes of view represented and the functions to IV. Copies of the Charter the Panel, consultants or independent be performed. Each panel member must To obtain a copy of the Panel’s contractors are not considered to be full- be employed full-time by a hospital, Charter, we refer readers to our website time employees in these organizations.) hospital system, or other Medicare at: http://www.cms.gov/Regulations- The HOP Panel currently consists of provider subject to payment under the and-Guidance/Guidance/FACA/ 13 panel members. Two additional OPPS (except for the CAH members, AdvisoryPanelonAmbulatoryPayment vacancies will occur in CY 2018. The since CAHs are not paid under the ClassificationGroups.html. list of HOP Panel members is located in OPPS). All members must have the FACA database, Advisory Panel on V. Collection of Information technical expertise to enable them to Hospital Outpatient Payment Committee Requirements participate fully in the Panel’s work. page, on the FACA database website at: Such expertise encompasses hospital This document does not impose https://www.facadatabase.gov/ payment systems; hospital medical care information collection requirements, committee/committee.aspx?cid= delivery systems; provider billing that is, reporting, recordkeeping or 1791&aid=76. systems; APC groups; Current third-party disclosure requirements. Panel members serve on a voluntary Procedural Terminology codes; and Consequently, there is no need for basis, without compensation, according alpha-numeric Health Care Common review by the Office of Management and to an advance written agreement; Procedure Coding System codes; and Budget under the authority of the however, for the meetings, CMS the use of, and payment for, drugs, Paperwork Reduction Act of 1995 (44 reimburses travel, meals, lodging, and medical devices, and other services in U.S.C. 3501 et seq.). related expenses in accordance with the outpatient setting, as well as other Dated: January 12, 2018. standard Government travel regulations. forms of relevant expertise. For Seema Verma, CMS has a special interest in ensuring, supervision deliberations, the Panel while taking into account the nominee Administrator, Centers for Medicare & shall have members that represent the Medicaid Services. pool, that the Panel is diverse in all interests of CAHs, who advise CMS only respects of the following: Geography; [FR Doc. 2018–01474 Filed 1–25–18; 8:45 am] regarding the level of supervision for rural or urban practice; race, ethnicity, hospital outpatient therapeutic services. BILLING CODE 4120–01–P sex, and disability; medical or technical It is not necessary for a nominee to specialty; and type of hospital, hospital possess expertise in all of the areas health system, or other Medicare DEPARTMENT OF HEALTH AND listed, but each must have a minimum HUMAN SERVICES provider subject to the OPPS. of 5 years of experience and currently Appointment to the HOP Panel shall be have full-time employment in his or her Centers for Medicare & Medicaid made without discrimination on the area of expertise. Generally, members of Services basis of age, race, ethnicity, gender, the Panel serve overlapping terms up to sexual orientation, disability, and [CMS–9106–N] 4 years, based on the needs of the Panel cultural, religious, or socioeconomic and contingent upon the rechartering of status. Medicare and Medicaid Programs; the Panel. A member may serve after the Quarterly Listing of Program Based upon either self-nominations or expiration of his or her term until a nominations submitted by providers or Issuances—October Through successor has been sworn in. December 2017 interested organizations, the Secretary, Any interested person or organization or his or her designee, appoints new may nominate qualified individuals. AGENCY: Centers for Medicare & members to the Panel from among those Self-nominations will also be accepted. Medicaid Services (CMS), HHS. candidates determined to have the Each nomination must include the ACTION: Notice. required expertise. New appointments following: are made in a manner that ensures a • Letter of Nomination stating the SUMMARY: This quarterly notice lists daltland on DSKBBV9HB2PROD with NOTICES balanced membership under the FACA reasons why the nominee should be CMS manual instructions, substantive guidelines. This notice requests considered. and interpretive regulations, and other nominations for HOP Panel members on • Curriculum vitae or resume of the Federal Register notices that were a continuous basis. Nominations for a nominee that includes an email address published from October through person not serving on the committee where the nominee can be contacted. December 2017, relating to the Medicare may be reconsidered as committee • Written and signed statement from and Medicaid programs and other vacancies arise, but should be updated the nominee that the nominee is willing programs administered by CMS. VerDate Sep<11>2014 20:14 Jan 25, 2018 Jkt 244001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\26JAN1.SGM 26JAN1

Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 3717 FOR FURTHER INFORMATION CONTACT: It is information whether the issuance or concerning each of the addenda possible that an interested party may regulation would fulfill that need. published in this notice. need specific information and not be Consequently, we are providing contact able to determine from the listed persons to answer general questions Addenda Contact Phone No. I. CMS Manual Instructions ...................................................................................................... Ismael Torres .......................... (410) 786–1864 II. Regulation Documents Published in the Federal Register .................................................. Terri Plumb ............................. (410) 786–4481 III. CMS Rulings ....................................................................................................................... Tiffany Lafferty ........................ (410) 786–7548 IV. Medicare National Coverage Determinations ..................................................................... Wanda Belle, MPA ................. (410) 786–7491 V. FDA-Approved Category B IDEs ......................................................................................... John Manlove ......................... (410) 786–6877 VI. Collections of Information ................................................................................................... William Parham ....................... (410) 786–4669 VII. Medicare-Approved Carotid Stent Facilities ...................................................................... Sarah Fulton, MHS ................. (410) 786–2749 VIII. American College of Cardiology-National Cardiovascular Data Registry Sites ............... Sarah Fulton, MHS ................. (410) 786–2749 IX. Medicare’s Active Coverage-Related Guidance Documents ............................................. JoAnna Baldwin, MS .............. (410) 786–7205 X. One-time Notices Regarding National Coverage Provisions .............................................. JoAnna Baldwin, MS .............. (410) 786–7205 XI. National Oncologic Positron Emission Tomography Registry Sites .................................. Stuart Caplan, RN, MAS ........ (410) 786–8564 XII. Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities ............... Linda Gousis, JD .................... (410) 786–8616 XIII. Medicare-Approved Lung Volume Reduction Surgery Facilities ...................................... Sarah Fulton, MHS ................. (410) 786–2749 XIV. Medicare-Approved Bariatric Surgery Facilities ............................................................... Sarah Fulton, MHS ................. (410) 786–2749 XV. Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ....................... Stuart Caplan, RN, MAS ........ (410) 786–8564 All Other Information ................................................................................................................ Annette Brewer ....................... (410) 786–6580 I. Background various manuals, memoranda, and accessibility. In addition, many of the statements necessary to administer and websites have listservs; that is, the The Centers for Medicare & Medicaid oversee the programs efficiently. public can subscribe and receive Services (CMS) is responsible for Section 1871(c) of the Act requires immediate notification of any updates to administering the Medicare and that we publish a list of all Medicare the website. These listservs avoid the Medicaid programs and coordination manual instructions, interpretive rules, need to check the website, as and oversight of private health statements of policy, and guidelines of notification of updates is automatic and insurance. Administration and oversight general applicability not issued as sent to the subscriber as they occur. If of these programs involves the regulations at least every 3 months in assessing a website proves to be following: (1) Furnishing information to the Federal Register. difficult, the contact person listed can Medicare and Medicaid beneficiaries, provide information. health care providers, and the public; II. Format for the Quarterly Issuance and (2) maintaining effective Notices III. How to Use the Notice communications with CMS regional This quarterly notice provides only This notice is organized into 15 offices, state governments, state the specific updates that have occurred addenda so that a reader may access the Medicaid agencies, state survey in the 3-month period along with a subjects published during the quarter agencies, various providers of health hyperlink to the full listing that is covered by the notice to determine care, all Medicare contractors that available on the CMS website or the whether any are of particular interest. process claims and pay bills, National appropriate data registries that are used We expect this notice to be used in Association of Insurance Commissioners as our resources. This is the most concert with previously published (NAIC), health insurers, and other current up-to-date information and will notices. Those unfamiliar with a stakeholders. To implement the various be available earlier than we publish our description of our Medicare manuals statutes on which the programs are quarterly notice. We believe the website should view the manuals at http:// based, we issue regulations under the list provides more timely access for www.cms.gov/manuals. authority granted to the Secretary of the beneficiaries, providers, and suppliers. Department of Health and Human We also believe the website offers a Dated: January 17, 2018. Services under sections 1102, 1871, more convenient tool for the public to Kathleen Cantwell, 1902, and related provisions of the find the full list of qualified providers Director, Office of Strategic Operations and Social Security Act (the Act) and Public for these specific services and offers Regulatory Affairs. Health Service Act. We also issue more flexibility and ‘‘real time’’ BILLING CODE 4120–01–P daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 20:14 Jan 25, 2018 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\26JAN1.SGM 26JAN1

8IZLE Publication Dates for the Previous Four Quarterly Notices arrangements to transfer material to a local library not designated as an We publish this notice at the end of each quarter reflecting FDL. Contact any library to locate the nearest FDL. This information is information released by CMS during the previous quarter. The publication available at http://www.gpo. gov/libraries/ dates of the previous four Quarterly Listing of Program Issuances notices In addition, individuals may contact regional depository libraries are: February 23, 2017 (82 FR 11456), May 5, 2017 (82 FR 21241), that receive and retain at least one copy of most federal government August 4, 2017 (82 FR 36404) and October 27, 2017 (82 FR 49819). We publications, either in printed or microfilm form, for use by the general are providing only the specific updates that have occurred in the 3—month public. These librariecs provide reference services and interlibrary loans; satNION/8IOZ ‘0Z Lrenuef ‘Kepu4/gt ‘ON ‘gg ‘TOA /JajstSay fedapayq period along with a hyperlink to the website to access this information and a however, they are not sales outlets. Individuals may obtain information contact person for questions or additional information. about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing Addendum I; Medicare and Medicaid Manual Instructions entitled Medicare and Medicaid Manual Instructions. To help FDLs locate (October through December 2017) 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 January 2018 Quarterly Average Sales partners, providers, contractors, Medicare Advantage organizations, and Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior State Survey Agencies to administer CMS programs. It offers day—to—day Quarterly Pricing Files use (CMS—Pub. 100—04) Transmittal No. 3878. operating instructions, policies, and procedures based on statutes and Addendum I lists a unique CMS transmittal number for each regulations, guidelines, models, and directives. In 2003, we transformed the instruction in our manuals or program memoranda and its subject number. CMS Program Manuals into a web user—friendly presentation and renamed A transmittal may consist of a single or multiple instruction(s). Often, it is it the CMS Online Manual System. necessary to use information in a transmittal in conjunction with information currently in the manual. For the purposes of this quarterly How to Obtain Manuals notice, we list only the specific updates to the list of manual instructions The Internet—only Manuals (IOMs) are a replica of the Agency‘s that have occurred in the 3—month period. This information is available on official record copy. Paper—based manuals are CMS manuals that were our website at www.cms. gov/Manuals. officially released in hardcopy. The majority of these manuals were transferred into the Internet—only manual (IOM) or retired. Pub 15—1, Pub Transmittal Manual/Subject/Publication Number Number 15—2 and Pub 45 are exceptions to this rule and are still active paper—based manuals. The remaining paper—based manuals are for reference purposes sition Handboo only. If you notice policy contained in the paper—based manuals that was Fee—for—Service Contractor Workload Transitions not transferred to the IOM, send a message via the CMS Feedback tool. Transition Handbooks Those wishing to subscribe to old versions of CMS manuals should 109 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction contact the National Technical Information Service, Department of 110 Affordable Care Act Bundled Payments for Care Improvement Initiative — Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone Recurring File Updates Models 2 and 4 April 2018 Updates (703—605—6050). You can download copies of the listed material free of 111 Update to Medicare Deductible, Coinsurance and Premium Rates for 2018 charge at: http://cms. gov/manuals. Basis for Determining the Part A Coinsurance Amounts Part B Annual Deductible Part B Premium How to Review Transmittals or Program Memoranda Those wishing to review transmittals and program memoranda can —Internet Only ManualUpdates to P: 100-04 to Conéct J access this information at a local Federal Depository Library (FDL). Under Errors and Omissions (SNF Requirements — General the FDL program, government publications are sent to approximately 1,400 Medicare SNF PPS Overview Medicare SNF Coverage Guidelines Under PPS designated libraries throughout the United States. Some FDLs may have Hospital Providers of Extended Care Services

daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Three- Day Prior Hospitalization Treatment Plans 'lhree-Day Prior Hospitalization- Foreign Hospital Hospice Services Effect on Spell of Illness Hospice Attending Practitioner 20:14 Jan 25, 2018 Medical Service of an Intern or Resident-in-Training Provision of Services to Hospice Patients in a RHC or FQHC Medical and Other Health Services Furnished to SNF Patients Preventive Health Services Services Furnished Under Arrangements With Providers Preventive Health Services in RHCs Definition of Durable Medical Equipment Preventive Health Services in FQHCs Copayment for FQHC Preventive Health Services Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 229 Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for 231 Implementation of Changes in the End-Stage Renal Disease (ESRD) Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2017 Prospective Payment System (PPS) and Payment for Dialysis Furnished for Jkt 244001 230 Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2017 Updates 232 January 2017 Cpdate of the Hospital Outpatient Prospective Payment System Table of Contents (OPPS) Index of Acronyms Covered Inpatient Hospital Services Covered Under Part A PO 00000 RHC General Information 233 Clarification of Payment Policy Changes for Negative Pressure Wound FQHC General Information Therapy (NPWT) Using a Disposable Device and the Outlier Payment RHC Staffing Requirements Methodology for Home Health Services RHC Temporary Staffing Waivers Table of Contents Frm 00047 RHC and FQHC Visits National60-Day Episode Rate Multiple Visits on Same Day Outlier Payments 3-Day Payment Window Consolidated Billing RHC Services Patient Confined to the Home Fmt 4703 FQHC Services Sequence of Qualitying Services and Other Medicare Covered Home Emergency Services Health Services Non RHC!FQHC Services Needs Skilled Nursing Care on an Intermittent Basis (Other than Solely Description of Non RHC/FQHC Services Venipuncture for the Purposes of Obtaining a Blood Sample), Physical Sfmt 4725 RHC Payment Rate Therapy, Speech-Language Pathology Services, or Has Continued Need for RHC Payment Limit and Exceptions Occupational T11erapy Payment Codes for FQHCs Billing Under the PPS Physician Certification FQHC PPS Payment Rate and Adjustments Supporting Documentation Requirements E:\FR\FM\26JAN1.SGM FQHC Payment Codes Wound Care RHC and FQHC Cost Report Requirements Medical Supplies (Except for Drugs and Biologicals Other Than Covered RHC and FQHC Cost Report Forms Osteoporosis Drugs), the Use of Durable Medical Equipment and RHC and FQHC Charges, Coinsurance, Deductible, and Waivers Furnishing Negative Pressure Wound Therapy Using a Disposable Device Comminglin Negative Pressure Wound Therapy Using a Disposable Device Dental, Podiatry, Optometry, and Chiropractic Services Coinsurance, Copayments, and Deductibles Graduate Medical Education 234 Clarification of Admission Order and Medical Review Requirements Transitional Care Management (TCM) Services Table of Contents Chronic Care Management (CCM) Services Covered Inpatient Hospital Services Covered Under Part A 26JAN1 Services and Supplies Furnished "Incident to" Physician's Services Hospital Inpatient Admission Order and Certification Provision oflncident to Services and Supplies 235 Removal of Contractor Requirement to Submit Opt Out Data into the Incident to Services and Supplies Furnished in the Patient's Home or Contractor Reporting of Operational and Workload Data (CROWD) System Location Other than the RHC or FQHC (Form 8) Payment to Physician Assistants 236 Medicare l:lenetlt Policy Manual - Chapter 10, Ambulance Locality and Services and Supplies Furnished Incident to NP, P A, and CNM Services Advanced Life Support (ALS) Assessment Locality Services and Supplies Incident to CP Services Ground Ambulance Services Mental Health Visits 237 Implementation of Changes in the End-Stage Renal Disease (ESRD) Physical Therapy, Occupational Therapy, and Speech Language Pathology Prospective Payment System (PPS) and Payment for Dialysis Furnished for Service Acute Kidnev Iniurv (AKI) in ESRD Facilities for Calendar Year (CY) 2018 Requirements for Visiting Nursing Services 3719 EN26JA18.018</GPH>

0sL€ 238 Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) 3877 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Medicare Benefit Policy Manual Chapter 13 Update of Instruction Treatment Plans or Home Care Plans 3878 January 2018 Quarterly Average Sales Price (ASP) Medicare Part B Drug Graduate Medical Education Pricing Files and Revisions to Prior Quarterly Pricing Files Services and Supplies Furnished "Incident to" Physician‘s Services 3879 Issued to a specific audience, not posted to Internet/Intranet due to a Provision of Incident to Services and Supplies Confidentiality of Instruction Incident to Services and Supplies Furnished in the Patient‘s Home or 3880 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity satNION/8IOZ ‘0Z Lrenuef ‘Kepu4/gt ‘ON ‘gg ‘TOA /JajstSay fedapayq Location Other than the RHC or FQHC of Instruction Payment for Incident to Services and Supplies 3881 Clinical Laboratory Fee Schedule Not Otherwise Classified, Not Otherwise Nurse Practitioner, Physician Assistant, and Certified Nurse Midwife Specified. or Unlisted Service or Procedure Code Data Collection Services 3882 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Payment to Physician Assistants of Instruction Services and Supplies Furnished Incident to NP, PA, and CNM Services 3883 Payment for Services Furnished by Qualified Nonphysician Anesthetists Clinical Psychologist and Clinical Social Worker Services Qualified Nonphysician Anesthetist Services Services and Supplies Incident to CP Services Entity or Individual to Whom Fee Schedule is Payable for Qualified Mental Health Visits Nonphysician Anesthetists Physical Therapy, Occupational Therapy, and Speech Language Pathology Anesthesia Fee Schedule Payment for Qualified Nonphysician Anesthetists Services Conversion Factors Used for Qualified Nonphysician Anesthetists Description of Visiting Nursing Services Conversion Factors for Anesthesia Services of Qualified Nonphysician Requirements for Visiting Nursing Services Anesthetists Furnished on or Afier January 1, 1992. Home Health Agency Shortage Area 3884 Issued to a specific audience, not posted to Internet/Intranet due to Treatment Plans Confidentiality of Instruction Telehealth Services 3885 Fiscal Year (FY) 2018 Inpatient Prospective Payment System (IPPS) and Hospice Attending Practitioner Long Term Care Hospital (LTCH) PPS Changes Provision of Services to Hospice Patients in an RHC or FQHC 3886 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Preventive Health Services in RHCs of Instruction Copayment and Deductible for RHC Preventive Health Services 3887 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Preventive Health Services in FQHCs of Instruction Copayment for FQHC Preventive Health Service 3888 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Care Management Services of Instruction Transitional Care Management Services General Care Management Services — Chronic Care Management and 3889 Issued to a specific audience, not posted to Internet/Intranct due to General Behavioral Health Integration Services Confidentiality of Instruction ol de 3890 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction IIyperbaric Oxygen (IIBO) Therapy (Sectlon C, Topical Application of 3891 Issued to a specific audience, not posted to Internet/Intranet due to Oxygen) Hyperbaric Oxygen Therapy Confidentiality of Instruction 3892 Issued to a specific audience, not posted to Internet/Intranct due to Confidentiality of Instruction 3872 Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2018 3893 Ambulance Inflation Factor for CY 2018 and Productivity Adjustment Ambulance Inflation Factor (AIF) 3873 Place of Service Codes 3874 Issued to a specific audience, not posted to Internet/Intranet due to 3894 File Conversions Related to the Spanish Translation of the Healthcare Common Procedure Coding System (HCPCS) Descriptions Confidentiality of Instruction 3895 Issued to a specific audience, not posted to Internet/Intranct due to Sensitivity 3875 Internet Only Manual Update to Pub. 100—04, Chapter 16, to Update Clinical of Instruction Lab Fee Schedule Layout 3896 Issued to a specific audience, not posted to Internet/Intranet due to 3876 Decommission the MCS Maintained HBCRBO81 Report ("Correct Coding Quarterly Savings Report") Confidentiality of Instruction Savings Report 3897 Pulmonary Rehabilitation (PR) Services Addition to Chapter 19, Indian Savings Record Format Health Services (IHS) Pulmonary Rehabilitation, Physical Therapy, Occupational Therapy,

Speech—Language Pathology and Diagnostic Audiology Services — Payment 3918 Therapy Cap Values for Calendar Year (CY) 2018 Policy Pulmonary Rehabilitation Services — Claims Processing 3919 Update to Rural Health Clinic (RHC) All Inclusive Rate (AIR) Payment Limit 3898 Correction to Prevent Payment on Inpatient Information Only Claims for for Calendar Year (CY) 2018 Beneficiaries Enrolled in Medicare Advantage Plans 3920 Qualified Medicare Reneficiary Indicator in the Medicare Fee—For—Service Claims Processing Requirements for TAVR Services for Medicare Claims Processing System Advantage (MA) Plan Participants 3921 IIyperbaric Oxygen (IIBO) Therapy (Section C, Topical Application of Claims Processing Requirements for TMVR for MR Services for Medicare Oxygen) satNION/8IOZ ‘0Z Lrenuef ‘Kepu4/gt ‘ON ‘gg ‘TOA /JajstSay fedapayq Advantage (MA) Plan Participants 3922 Update to the Federally Qualified Health Center (FQHC) Prospective 3899 Issued to a specific audience, not posted to Internet/Intranet due to Payment System (PPS) for Calendar Year (CY) 2018 — Recurring File Update Confidentiality of Instruction 3923 Quarterly Update of HCPCS Codes Used for Home Health Consolidated 3900 Issued to a specific audience, not posted to Internet/Intranet due to Billing Enforcement Confidentiality of Instruction 3924 2018 Annual Update to the Therapy Code List 3901 Update to Pub 100—04, Chapter 18 Preventive and Screening Services — 3925 Changes to the Laboratory National Coverage Determination (NCD) Edit Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) Software for January 2018 3902 New Waived Tests 3926 Issued to a specific audience, not posted to Internet/Intranet due to 3903 Annual Medicare Physician Fee Schedule (MPFS) Files Delivery and Confidentiality of Instruction Implementation and Medicare Physician Fee Schedule Database (MPFSDB) 3927 Instructions for Downloading the Medicare ZIP Code File for April 2018 2018 File Layout Manual Addendum 3928 O[[—Cycle Update to the Skilled Nursing Facility (SNF) Prospective Payment 3904 Issued to a specific audience, not posted to Internet/Intranet due to System (PPS) Fiscal Year (FY) 2018 Pricer Confidentiality of Instruction 3929 Elimination of the GT Modifier for Telehealth Services 3905 Issued to a specific audience, not posted to Internet/Intranet due to 3930 Hospice Manual Update Only for Section 30.3 Confidentiality of Instruction Data Required on the Institutional Claim to A/B MAC (HHH 3906 Issued to a specific audience, not posted to Internet/Intranet due to Hospice Pricer Program Confidentiality of Instruction Input/Output Record Layout 3907 October 2017 Integrated Outpatient Code Editor (LOCE) Specifications 3931 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Version 18.3 of Instruction 3908 Influenza Vaccine Payment Allowances — Annual Update for 2017—2018 ial R Season 3909 Quarterly Update for the Durable Medical Equipment, Prosthetics. Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) — January 2018 3910 Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update 3911 New Positron Emission Tomography (PET) Radiopharmaceutical/Tracer Unclassified Codes 3912 Off—Cycle Update to the Long Term Care Hospital (LTCH) Prospective Participating Religious Nonmedical Healthcare Institutions Payment System (PPS) Fiscal Year (FY) 2018 Pricer 172 Revision to State Operations Manual (SOM) Appendix A — Survey Protocol, 3913 Common Edits and Enhancements Modules (CEM) Code Set Update Regulations and Interpretive Guidelines for Hospitals 3914 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 173 Revisions to State Operation Manual (SOM), Appendix PP Guidance to of Instruction Surveyors for Long Term Care Facilities 3915 Implement Operating Rules — Phase III Electronic Remittance Advice (ERA) 174 Revisions to the State Operations Manual (SOM) Appendix P Electronic Funds Transfer (EFT): CORE 360 Uniform Use of Claim 175 Revisions to State Operations Manual (SOM) Appendix J, Part II — Adjustment Reason Codes (CARC), Remittance Advice Remark Codes Interpretive Guidelines — Responsibilities of Intermediate Care Facilities for (RARC) and Claim Adjustment Group Code (CAGC) Rule — Update from Individuals with Intellectual Disabilities Council for Affordable Quality Healthcare (CAQH) Committee on Operating 176 Revisions to State Operations Manual (SOM) Appendix A — Survey Protocol, Rules for Information Exchange (CORE) Regulations and Interpretive Guidelines for Hospitals 3916 Claim Status Category and Claim Status Codes Update 3917 Calendar Year (CY) 2018 Participation Enrollment and Medicare Participating Physicians and Suppliers Directory (MEDPARD) Procedures IeSL€E

oL 186 IVIG Demonstration: Payment Update for 2018 747 Update to Reporting Requirements 187 Next Generation Accountable Care Organization (NGACO) Year Three Reconsideration Requests — Non—certified Providers/Suppliers Benefit Enhancements External Reporting Requirements 748 Defending Medical Review Decisions at Administrative Law Judge (ALJ) 1928 Multi—Carrier System (MCS), Fiscal Intermediary Shared System (FISS) and Hearings VIPS Medicare Shared System (VMS) Automation of Prior Authorization Election of Status (PA) Coordination of the ALJ Hearing Requests/Pre—Claim Reviews (PCR) and their Responses with Multiple satNION/8IOZ ‘0Z Lrenuef ‘Kepu4/gt ‘ON ‘gg ‘TOA /JajstSay fedapayq Party in the ALJ Hearing Services (for programs like Home Health (HH)) via the Electronic The ALJ Hearing Submission of Medical Documentation (esMD) System 749 Issued to a specific audience, not posted to Internet/Intranet due to 1929 CMS Approved Review Topics for Durable Medical Equipment, Prosthetic, Confidentiality of Instruction Orthotics, Supplies (DMEPOS) 750 Proof of Delivery Documentation Requirements 1930 National Provider Identification Crosswalk System (NPICS) Retirement Supplier Proof of Delivery Documentation Requirements Analysis Only — Engage Shared Systems Maintainers (SSMs) and Medicare Proof of Delivery and Delivery Methods Administrative Contractors (MACs) in Meetings and Correspondence Related Proof of Delivery Requirements for Recently Eligible Medicare FFS to the NPICS Retirement with the Integrated Data Repository (IDR) Team Beneficiaries 1931 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Supplier Documentation of Instruction 751 Clarifying Signature Requirements 1932 Shared System Enhancement 2015: Identify Inactive Medicare Demonstration 752 Issued to a specific audience, not posted to Internet/Intranet due to Projects within the Fiscal Intermediary Shared System — Removing/Archiving Confidentiality of Instruction demonstration codes 38, 42 and 43) 753 Certificates of Medical Necessity (CMN) and Durable Medical Equipment 1933 Shared System Enhancement 2015: Identify Inactive Medicare Demonstration (DME) Information Forms (DIF) Projects within the Fiscal Intermediary Shared System — Removing/Archiving 754 Issued to a specific audience, not posted to Internet/Intranet due to demonstration codes 38, 42 and 43) Confidentiality of Instruction 1934 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 755 Tracking Medicare Contractors®‘ Prepayment and Postpayment Reviews of Instruction 1935 FISS Process Enhancements — Analysis Only 1936 Modifications to the National Coordination of Benefits Agreement (COBA) Crossover Process 1937 Provider Education and Referral Reporting 1938 Archiving National Provider Identifier Crosswalk System (NPICS) System Logic in the Durable Medical Equipment (DME) Claims Processing System 1939 Fiscal Intermediary Shared Systems (FISS) Enhancements to the Mass Adjustment of Process Recovery Audit Contractor (RAC) Claims 1940 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instruction 1941 Transitional Drug Add—on Payment Adjustment (TDAPA) for patients with Acute Kidney Injury (AKT) 1942 Common Working File (CWEF) to Medicare Beneficiary Database (MBD) 180 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Extract File Changes for Detailed Skilled Nursing Facility Data to Support of Instruction HIPAA Eligibility Transact.lon System (.HETS) — — 181 Next Generation ACO Model — Weekly AIPBP Reduction File Change 1943 Assign the Correct 935 Indicator on Adjustment Claims Submitted through 182 Issued to a specific audience, not posted to Internet/Intranct due to Sensitivity the Provider ?ortal — — — of Instruction 1944 MCS Ar}alysm Only: Undeliverable Medicare Summary Notices (UMSNs) — 183 Issued to a specific audience, not posted to Internet/Intranet due to Beneficiary Do N(_)t Forward Procefs — Confidentiality of Instruction 1945 Ad(?, Date of Receipt to the Beneficiary Data Streamlining (BDS) Part A 184 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Claims Layout — — — of Instruction 1946 Sl.lar.ed System !:nhan.cement 2015: Removing/Archiving Obsolete Reports 185 Demonstration: Payment Update for 2018 within the Multi—Carrier System (MCS)

1947 Health Insurance Portability and Accountability Act (HIPAA) Electronic Data Expert Claims Processing System (ECPS) — Analysis Only Interchange (EDI) Front End Updates for April 2018 1971 Modifications to the National Coordination of Benefits Agreement (COBA) 1948 Archiving National Provider Identifier Crosswalk System (NPICS) System Crossover Process Logic in the Muti—Carrier System (MCS) 1972 Analysis Only: Develop Enhanced Claims Search Reporting in Fiscal 1949 Remove Obsolete Edits from the Fiscal Intermediary Shared Systems (FISS) Intermediary Shared System (FISS) 1950 Fiscal Intermediary Shared System (F‘ISS) and VIFS Medicare Shared System 1973 Multi—Carrier System (MCS) Modernization Proof of Concept Number 8 (VMS) to Update Records Based on the Automation of Prior Authorization 1974 Revision of PWK (Paperwork) Fax/Mail Cover Sheets satNION/8IOZ ‘0Z Lrenuef ‘Kepu4/gt ‘ON ‘gg ‘TOA /JajstSay fedapayq (PA) Requests/Pre—Claim Reviews (PCR) and their Responses with Multiple 1975 ICD—10 and Other Coding Revisions to National Coverage Determinations Services (for programs like Home Health (HH)) (NCDs) 1951 Shared System Enhancement 2015: Removing/Archiving Obsolete On 1976 Common Working File (CWF) to Modify CWF Provider Queries to Only Request Jobs within the Multi—Carrier System (MCS) Accept National Provider Identifier (NPI) as valid Provider Number 1952 Calculating Interim Rates for Graduate Medical Education (GME) Payments 1977 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity to New Teaching Hospitals of Instruction 1953 Shared System Enhancement 2014; Implementation of Fiscal Intermediary 1978 Implementation of Changes to Certificate of Medical Necessity (CMN) and Shared System (FISS) Obsolete On—Request Jobs — Phase 1 CMN DME Information Form (CMN DIF) as a result of the New Medicare 1954 New Common Working File (CWF) Medicare Secondary Payer (MSP) Type Card Project for T iability Medicare Set—Aside Arrangements (LMSAs) and No—Fault 1979 Shared System Enhancement 2015: Identify Inactive Medicare Demonstration Medicare Set—Aside Arrangements (NFMSAs) Projects Within the Common Working File (CWEF) 1955 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 1980 Shared System Enhancement 2015: Removing/Archiving Obsolete On of Instruction Request Jobs within the Multi—Carrier System (MCS) 1956 Analysis and Design Working Sessions for the Development ofa Pre— 1981 Fiscal Year (FY) 2014 and 2015 Worksheet S—10 Revisions: Further Payment Common Additional Documentation Request (ADR) Letter Extension for All Inpatient Prospective Payment System (IPPS) Hospitals 1957 Shared System Enhancement 2015: Identify Inactive Medicare Demonstration 1982 Line Level versus Claim Level Reporting — Analysis Only Projects Within the Common Working File (CWF) — Removing/Archiving 1983 Shared System Enhancement 2015: Identify Inactive Medicare Demonstration Demonstration codes 51 and 56 Projects within the Fiscal Intermediary Shared System — Removing/Archiving 1958 Shared System Enhancement 2014; Implementation of Fiscal Intermediary demonstration codes 38, 42 and 43) Shared System (FISS) Obsolete Financial and Expert Claims Processing 1984 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity System (ECPS) Reports — Phase 1 f i 1959 Shared System Enhancement 2014: Implementation of Fiscal Intermediary : Shared System (FISS) Obsolete Financial and Expert Claims Processing ssued to a si)ccn ic audience, not posted to Internet/Intranct duc to System (ECPS) Reports — Phase 1 Confidentiality of Instruction 1960 Implementation of the Award for the Jurisdiction Part A and Part B Medicare 71 Issued to a specific audience, not posted to Internet/Intranet due to Administrative Contractor (JJ A/B MAC) Confidentiality of Instruction 1961 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 72 Issued to a specific audience, not posted to Internet/Intranet due to of Instruction nfidentiality of Instructi 1962 Shared System Enhancement 2014: Implementation of Fiscal Intermediary Shared System (FISS) Obsolete Core Reports — Phase 1 one 1963 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instruction 1964 Shared System Enhancement 2014; Implementation of Fiscal Intermediary Shared System (FISS) Obsolete Core Reports — Phase 1 1965 Shared System Enhancement 2015: Resolve Operating Report (ORPT) Issues — Development and Implementation 1966 Out—of—Jurisdiction Providers (OJP) and Qualified Chain Providers (QCP) Move to Correct A/B MAC Jurisdiction — Analysis CR Only 1967 CICS Region Merge(s) for A/B MACs — Analysis Only 1968 Tracking Status of Claims Adjustments 1969 Partial Settlement of 2—Midnight Policy Court Cases 1970 Establish an Automated Process For Creating Mass Adjustments Utilizing bA b

PoL€ title, the date the publication was issued, and the effective date of the Addendum II: Regulation Documents Published decision. An NCD is a determination by the Secretary for whether or not a in the Federal Register (October through December 2017) particular item or service is covered nationally under the Medicare Program Regulations and Notices (title XVIII of the Act), but does not include a determination of the code, if Regulations and notices are published in the daily Federal any, that is assigned to a particular covered item or service, or payment Register. To purchase individual copies or subscribe to the Federal determination for a particular covered item or service. The entries below Register, contact GPO at www.gpo.gov/fdsys. When ordering individual include information concerning completed decisions, as well as sections on satNION/8IOZ ‘0Z Lrenuef ‘Kepu4/gt ‘ON ‘gg ‘TOA /JajstSay fedapayq copies, it is necessary to cite either the date of publication or the volume program and decision memoranda, which also announce decisions or, in number and page number. some cases, explain why it was not appropriate to issue an NCD. The Federal Register is available as an online database through Information on completed decisions as well as pending decisions has also GPO Access. The online database is updated by 6 a.m. each day the been posted on the CMS website. For the purposes of this quarterly notice, Federal Register is published. The database includes both text and we are providing only the specific updates that have occurred in the 3— graphics from Volume 59, Number 1 (January 2, 1994) through the present month period. This information is available at: www.cms.gov/medicare— date and can be accessed at http://www.gpoaccess.gov/fr/index.html. The coverage—database/. For questions or additional information, contact following website http:/www.archives. gov/federal—register/ provides Wanda Belle, MPA (410—786—7491). information on how to access electronic editions, printed editions, and reference copies. Title NCDM Transmittal Issue Date Effective This information is available on our website at: Section Number Date Hyperbaric Oxygen http://www.cms. gov/quarterlyproviderupdates/downloads/Regs— (HBO) Therapy 4Q17QPU.pdf NCD 20.29 203 11/17/2017 04/03/2017 (Section C, Topical For questions or additional information, contact Terri Plumb Application of Oxygen) (410—786—4481). Addendum V: FDA—Approved Category B Investigational Device Addendum III:;: CMS Rulings Exemptions (IDEs) (October through December 2017) (October through December 2017) Addendum V includes listings of the FDA—approved CMS Rulings are decisions of the Administrator that serve as investigational device exemption (IDE) numbers that the FDA assigns. The precedent final opinions and orders and statements of policy and listings are organized according to the categories to which the devices are interpretation. They provide clarification and interpretation of complex or assigned (that is, Category A or Category B), and identified by the IDE ambiguous provisions of the law or regulations relating to Medicare, number. For the purposes of this quarterly notice, we list only the specific Medicaid, Utilization and Quality Control Peer Review, private health updates to the Category B IDEs as of the ending date of the period covered insurance, and related matters. by this notice and a contact person for questions or additional information. The rulings can be accessed at http://www.cms. gov/Regulations— For questions or additional information, contact John Manlove (410—786— and—Guidance/Guidance/Rulings. For questions or additional information, 6877). contact Tiffany Lafferty (410—786—7548). Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360¢) devices fall into one of three classes. To assist CMS under this categorization Addendum IV: Medicare National Coverage Determinations process, the FDA assigns one of two categories to each FDA—approved (October through December 2017) investigational device exemption (IDE). Category A refers to experimental Addendum IV includes completed national coverage IDEs, and Category B refers to non—experimental IDEs. To obtain more determinations (NCDs), or reconsiderations of completed NCDs, from the information about the classes or categories, please refer to the notice quarter covered by this notice. Completed decisions are identified by the published in the April 21, 1997 Federal Register (62 FR 19328). section of the NCD Manual (NCDM) in which the decision appears, the

daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 IDE Device Start Date IDE Device Start Date Gl50231 Mayo Clinic Nerve Scaffold #1 (MCNSl) 12/14/2017 Gl60258 REZUM SYSTEM 12/15/2017 20:14 Jan 25, 2018 Gl70177 Medtronic IN.P ACT Admiral Drug-Coated Balloon 10/04/2017 Gl70229 Gel-Bead embolization spheres 10/04/2017 Gl702S6 Transmural Transcaval Closure Device (Delivery System & 12115/2017 Gl70226 Strattice Reconstructive Tissue Matrix 10/05/2017 Implant); Guidewire for use with Transcaval Closure Device Gl70227 DiamondTemp Ablation Svstem 10/06/2017 Gl70287 Invisalign Palatal Expander 12/15/2017 Gl70232 LC BeadLUMI 10/13/2017 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices Gl70237 Exablate Model 4000 Type 1 10/20/2017 Gl70051 Left Gastric Artery Embolization for Glycemic Control 10/24/2017 Addendum VI: Approval Numbers for Collections of Information Jkt 244001 Gl70100 Axonics Sacral Neuromodulation System 10/27//2017 Gl70240 Doctormate Renqiao Remote Ischemic Conditioning Device 10/27/2017 (October through December 2017) Type IPC-906X All approval numbers are available to the public at Reginfo.gov. Gl70242 A High-Performance ECoG-based "\Jeural Interface for 10/27/2017 Under the review process, approved information collection requests are PO 00000 Communication and Neuroprosthetic Control assigned Ol'v!B control numbers. A single control number may apply to Gl70247 HiResolution Bionic Ear System 11102/2017 several related information collections. This information is available at Gl60196 Neovasc Reducer System 11/03/2017 Gl70248 ClonoSEQ in-vitro assay, laboratory developed test 11107/2017 www.reginfo.gov/public/do/PRAMain. For questions or additional information, contact William Parham (410-786-4669). Frm 00053 Gl70252 Trace IT Tissue Spacer 11/07/2017 Gl70251 Wingman Crossing Catheter 11/08/2017 Gl70179 SYNERGY Everolimus-Eluting Platinum Chromium 11109/2017 Addendum VII: Medicare-Approved Carotid Stent Facilities, Coronary Stent System (October through December 2017) Fmt 4703 Gl70261 AXIOS Stent and Electrocautery Enhanced Delivery System 11109/2017 lOmmxlOmm; AXIOS Stent and Electrocautery Enhanced Addendum VII includes listings of Medicare-approved carotid Delivery System 15mmxl0mm;AXIOS Stent and stent facilities. All facilities listed meet CMS standards for perforrning Electrocautery Enhanced Delivery System 20mmx10mm carotid artery stenting for high risk patients. On March 17, 2005, we issued Sfmt 4725 Gl70189 Contour PV A, Embosphere and Embozene 11/14/2017 our decision memorandum on carotid artery stenting. We determined that Gl70254 Wallstent 11/16/2017 carotid artery stenting with embolic protection is reasonable and necessary Gl70257 SPRINT PNS System for the Treatment of Back Pain 1111712017 Gl70258 CardioME.Y!S HF System 11/17/2017 only if performed in facilities that have been determined to be competent in E:\FR\FM\26JAN1.SGM Gl70083 PQ Bypass System 11/20/2017 performing the evaluation, procedure, and follow-up necessary to ensure Gl70219 Cardio Flow Orbital Atherectomy System 11/21/2017 optimal patient outcomes. We have created a list of minimum standards for Gl70205 Brown Glaucoma Implant 11/22/2017 facilities modeled in part on professional society statements on competency. Gl70268 Activa PC+S Neurostimulation System; Neurostimulation 11124/2017 All facilities must at least meet our standards in order to receive coverage Systems for Deep Brain Stimulation Gl70270 SurgiMed Meshed Collagen Matrix 11/29/2017 for carotid artery stenting for high risk patients. For the purposes of this Gl70273 Medtronic Arctic Front Advance Cardiac Cryoballoon 11130/2017 quarterly notice, we are providing only the specific updates that have catheter occurred in the 3-month period. This information is available at: 26JAN1 Gl70272 Study of Left Main Coronary Artery Healing after PCI with 12/01/2017 http://www. ems. gov/MedicareApprovedFacilitie/CASF/list. asp#TopOfPage Boston Scientific Synergy Bioabsorbable Polymer Stent For questions or additional information, contact Sarah Fulton, MHS (SOLbMN) Gl70126 MMS .Y!icroStent System 12/08/2017 (410-786-2749). Gl70279 Aries 2 Device 12/08/2017 Gl70282 SYNERGY Everolimus-Eluting Platinum Chromium 12/13/2017 Coronary Stent System Gl70283 Cardioblate BP2, Cardioblate LP, Cardioblate Pen, 12/13/2017 Cardioblate XL Pen, Cardioblate MAPs; Cardioblate Generator; Cardioblate CryoFlex Probes and Clamp; Cardioblate CryoFlex Console 3725 EN26JA18.024</GPH>

90LE Facility Provider Effective Date State Facility Provider Effective Date State Number Aurora, IL 60506 ood SamaritanHo pifa M 902865355 _ 10/20/2017 FROM: Resurrection Medical 140117 04/12/2005 IL Center 1000 Montauk Highway Center West Islip, NY 11795 TO: Presence Resurrection Salt Lake Regional Medical Center 1417988833 12/11/2017 UT Medical Center 1050 E. South Temple 35 West Talcott Avenue satNION/8IOZ ‘0Z Lrenuef ‘Kepu4/gt ‘ON ‘gg ‘TOA /JajstSay fedapayq Salt Lake City, UT 84102 Chicago, IL 60631 FROM: Provena Saint Joseph 140217 05/11/2005 IL FROM: SSM St. Mary‘s Health 26—0091 01/12/2012 MoO Hospital Center TO: Presence Saint Joseph TO: SSM Health St Mary‘s Hospital Hospital — St. Louis 77 North Airlite Street 6420 Clayton Road Elgin, IL 60123—4912 Richmond Heights, MO 63117 FROM: Provena Saint Joseph 140007 09/06/2005 IL FROM: DePaul Health Center 26—0104 10/30/2009 MoO Medical Center TO: SSM Health DePaul Hospital TO: Presence Saint Joseph — St. Louis Medical Center 12303 DePaul Drive 333 North Madison Street St. Louis, MO 63044—2588 Joliet, IL 60435—6595 FROM: SSM St. Clare Health 26—0081 01/23/2006 MoO FROM: Provena St. Mary‘s 140155 06/01/2005 IL Center Hospital TO: SSM Health St. Clare TO: Presence St. Mary‘s Hospital Hospital — Fenton 500 West Court Street 1015 Bowles Avenue Kankakee, IL 60901 Fenton, MO 63026 FROM: Tenet Hospital Limited 450678 09/07/2007 TX FROM: SSM St. Joseph Health 26—0005 04/26/2005 MoO TO: Baylor Scott & White Center Medical Center—White Rock TO: SSM Health St. Joseph 9440 Poppy Drive Hospital — St Charles Dallas, TX 75218 300 First Capitol Drive FROM: Foote Hospital 230092 11/03/2005 MI St. Charles, MO 63301 TO: Henry Ford Allegiance Health FROM: Saint Louis University 26—0105 05/17/2005 MoO 205 North East Avenue Hospital Jackson, MI 49201 TO: SSM Health Saint Louis FROM: Rogue Valley Medical 380018 05/05/2005 OR University Hospital Center 3635 Vista at Grand Boulevard TO: Asante Rogue Regional St. Louis, MO 63110 Medical Center P.O. Box 15250 2825 East Barnett Road SSM—SLUH, INC Medford, OR 97504 FROM: St Mary‘s Medical Center 15—0100 05/17/2005 IN TO: St. Vincent Evansville Facility Provider Effective Date State 3700 Washington Avenue Number Evansville, IN 47740 Lee‘s Summit Medical Center 260190 05/17/2005 MoO FROM: Provena Mercy Medical 140174 07/15/2005 IL 2100 SE Blue Parkway Center TLee‘s Summit, MO 64063 TO: Presence Mercy Medical Center 1325 North Highland Avenue

Addendum VII: Facility City State Hospital American College of Cardiology‘s National Cardiovascular Data Newton Wellesley Hospital Newton MA Registry Sites (October through December 2017) Gerald Champion Regional Medical Alamogordo NM Addendum VIII includes a list of the American College of Cardiology‘s National Cardiovascular Data Registry Sites. We cover ores i Termination Requested implantable cardioverter defibrillators (ICDs) for certain clinical Central Maine Medical Center Lewiston ME indications, as long as information about the procedures is reported to a Termination Requested——Please see case satNION/8IOZ ‘0Z Lrenuef ‘Kepu4/gt ‘ON ‘gg ‘TOA /JajstSay fedapayq central registry. Detailed descriptions of the covered indications are 00325173. We have consolidated ICD to PID available in the NCD. In January 2005, CMS established the ICD 288750. Forrest General Hospital Hattiesburg MS Abstraction Tool through the Quality Network Exchange (QNet) as a Service/Facility Closed——This facility had temporary data collection mechanism. On October 27, 2005, CMS duplicate accounts. The ICD Registry was announced that the American College of Cardiology‘s National merged with PID 266955. Access to the ICD Cardiovascular Data Registry (ACC—NCDR) ICD Registry satisfies the data Registry for PID 656089 will cease 12/31/17. Nicholas H. Noyes Memorial Hospital Dansville NY reporting requirements in the NCD. Hospitals needed to transition to the Termination Requested ACC—NCDR ICD Registry by April 2006. University Campus of CHI Health CUMC— Omaha NE Effective January 27, 2005, to obtain reimbursement, Medicare Bergan Mercy NCD policy requires that providers implanting ICDs for primary prevention Termination Requested clinical indications (that is, patients without a history of cardiac arrest or St. Joseph Regional Medical Center — South Bend Mishawaka IN Termination Requested—— Please see case spontaneous arrhythmia) report data on each primary prevention ICD 00325200. We have consolidated the ICD procedure. Details of the clinical indications that are covered by Medicare registry to PID 663672. and their respective data reporting requirements are available in the Willis Knighton Pierremont Shreveport LA Medicare NCD Manual, which is on the CMS website at Termination Requested Union Hospital Elkton MD http://www.cms. hhs. gov/Manuals/IOM/itemdetailasp?filterType=nonc&filt Termination Requested erByDID=99&sortByDID=1 & sortOrder=ascending&itemID=CMSO14961 Melbourne Same Day Surgery Melbourne FL A provider can use either of two mechanisms to satisfy the data Termination Requested reporting requirement. Patients may be enrolled either in an Investigational Integris Grove Hospital Grove OK Termination Requested——Please see case Device Exemption trial studying ICDs as identified by the FDA or in the 00325232. We are consolidating the ICD ACC—NCDR ICD registry. Therefore, for a beneficiary to receive a Account to PID 334434 so all registries are under Medicare—covered ICD implantation for primary prevention, the beneficiary one account. must receive the scan in a facility that participates in the ACC—NCDR ICD registry. The entire list of facilities that participate in the ACC—NCDR ICD Addendum IX: Active CMS Coverage—Related Guidance Documents registry can be found at www.nedr.com/webnedr/common (October through December 2017) For the purposes of this quarterly notice, we are providing only the CMS issued a guidance document on November 20, 2014 titled specific updates that have occurred in the 3—month period. This information "Guidance for the Public, Industry, and CMS Staff: Coverage with is available by accessing our website and clicking on the link for the Evidence Development Document". Although CMS has several policy American College of Cardiology‘s National Cardiovascular Data vehicles relating to evidence development activities including the Registry at: www.nedr.com/webnedr/common. For questions or additional investigational device exemption (IDE), the clinical trial policy, national information, contact Sarah Fulton, MHS (410—786—2749). coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS‘s Cit implementation of coverage with evidence development (CED) through the Our Lady of the Lal _Gonnzales _ LCLE

80LE national coverage determination process. The document is available at order to receive coverage for VADs implanted as destination therapy. On http://www.cms.gov/medicare—coverage—database/details/medicare— October 1, 2003, we issued our decision memorandum on VADs for the coverage—document—details.aspx?MCDId=27. There are no additional clinical indication of destination therapy. We determined that VADs used Active CMS Coverage—Related Guidance Documents for the 3—month as destination therapy are reasonable and necessary only if performed in period. For questions or additional information, contact facilities that have been determined to have the experience and JoAnna Baldwin, MS (410—786—7205). infrastructure to ensure optimal patient outcomes. We established facility satNION/8IOZ ‘0Z Lrenuef ‘Kepu4/gt ‘ON ‘gg ‘TOA /JajstSay fedapayq standards and an application process. All facilities were required to meet Addendum X: our standards in order to receive coverage for VADs implanted as List of Special One—Time Notices Regarding National Coverage destination therapy. Provisions (October through December 2017) For the purposes of this quarterly notice, we are providing only the There were no special one—time notices regarding national specific updates to the list of Medicare—approved facilities that meet our coverage provisions published in the 3—month period. This information is standards that have occurred in the 3—month period. This information is available at www.cms. hhs.gov/coverage. For questions or additional available at information, contact JoAnna Baldwin, MS (410—786 7205). http://www.cms. gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage. For questions or additional information, contact Linda Gousis, JD, Addendum XI:; National Oncologic PET Registry (NOPR) (410—786—8616). (October through December 2017) Addendum XI includes a listing of National Oncologic Positron Facility Provider Date Approved State Number Emission Tomography Registry (NOPR) sites. We cover positron emission tomography (PET) scans for particular oncologic indications when they are Lovelace Medical Center 320009 10/09/2017 NM performed in a facility that participates in the NOPR. 601 Dr. Martin Luther King Jr. Ave. NE In January 2005, we issued our decision memorandum on positron Albuquerque, NM 87102 emission tomography (PET) scans, which stated that CMS would cover JFK Medical Center 100080 01/25/2017 FL 5301 South Congress Avenue PET scans for particular oncologic indications, as long as they were Atlantis, FL 33462 performed in the context of a clinical study. We have since recognized the Pitt County Memorial Hospital, Inc. 340040 09/27/2017 NC National Oncologic PET Registry as one of these clinical studies. d/b/a Vidant Medical Center Therefore, in order for a beneficiary to receive a Medicare—covered PET 2100 Stantonsburg Road Greenville, NC 27834 scan, the beneficiary must receive the scan in a facility that participates in CHI St. Vincent Heart Clinic 040007 11/22/2017 AR the registry. There were no additions, deletions, or editorial changes to the 2 St. Vincent Circle listing of National Oncologic Positron Emission Tomography Registry Little Rock, AR 72205 (NOPR) in the 3—month period. This information is available at Hillerest Medical Center 370001 12/04/2017 OK http://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. 1120 S. Utica Tulsa, OK 74104 For questions or additional information, contact Stuart Caplan, RN, MAS : Inova Fairfax Hospita (410—786—8564). TO: Inova Fairfax Medical Campus 3300 Gallows Road Addendum XII:; Medicare—Approved Ventricular Assist Device Falls Church, VA 22042 Joint Commission # 6351 (Destination Therapy) Facilities (October through December 2017) Delray Medical Center, Inc 100258 08/17/2017 FL Addendum XII includes a listing of Medicare—approved facilities 5352 Linton Boulevard that receive coverage for ventricular assist devices (VADs) used as Delray Beach, FL 33484 destination therapy. All facilities were required to meet our standards in Joint Commission # 5215

daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Facility Provider Date Approved State Facility Provider Date Approved State Number Number UT Southwestern Medical 450044 08/09/2017 TX Center 20:14 Jan 25, 2018 Center/William P. Clements Jr. TO: Einstein Medical Center University Hospital Philadelphia 6201 Harry Hines Boulevard 5501 Old York Road Dallas, TX 75390 Philadelphia, PA 19141 Joint Connnission #9013. Hospital Joint Connnission # 6118 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices previously listed as St. Paul Medical Lancaster General Hospital 390100 10/04/2017 PA Center. 555 North Duke Street Jkt 244001 "ew York Presbyterian- Columbia 330101 09/24/2015 NY Lancaster, P A 17602 University Medical Center Joint Connnission # 6086 622 West 168th Street "ew York, NY 10032 PO 00000 Joint Connnission # 5838 University of Utah Hospital 460009 08/09/2017 UT Addendum XIII: Lung Volume Reduction Surgery (LVRS) 50 N Medical Drive (October through December 2017) Salt Lake City, UT 84132 Addendum XIII includes a listing of Medicare-approved facilities Frm 00057 Joint Connnission # 9544 that are eligible to receive coverage for lung volume reduction surgery. "orthwestern Memorial Hospital 140281 08/19/2017 IL 251 E Huron Street Chicago, IL 60611 Until May 17, 2007, facilities that participated in the National Emphysema Joint Connnission # 7267 Treatment Trial were also eligible to receive coverage. The following three Fmt 4703 Texas Heart Hospital of the Southwest 670025 08/23/2017 TX types of facilities are eligible for reimbursement for Lung Volume DBA The Heart Hospital Baylor Plano Reduction Surgery (L VRS): 1100 Allied Drive Plano, TX 75093 Joint Connnission # 440319 • National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only Sfmt 4725 "mth Carolina Baptist Hospital DBA 340047 08/19/2017 NC Wake Forest Baptist Medical Center with the other programs); .\i!edical Center Boulevard • Credentialed by the Joint Commission (formerly, the Joint Winston Salem, NC 27157 Commision on Accreditation of Healthcare Organizations (JCAHO)) under E:\FR\FM\26JAN1.SGM .Joint Commission # 6571 .\i!ayo Clinic 100151 10/04/2017 FL their Disease Specific Certification Program for L VRS; and 4500 San Pablo Road • Medicare approved for lung transplants. Jacksonville, FL 32224 Only the first two types are in the list. There were no updates to Joint Connnission # 369946 the listing of facilities for lung volume reduction surgery published in the Baylor University Medical Center at 450021 11101/2017 TX Dallas 3-month period. This infonnation is available at 3500 Gaston Avenue Dallas, TX 75246 www.cms.gov/MedicareApprww. ems. gov /MedicareApprovedF acilitie/B SF /list.asp#To questions or additional information, contact Sarah Fulton, MHS 26JAN1 Joint Connnission # 8993 Seton Medical Center Austin 450056 10/04/2017 TX (410-786-27 49). 1201 W 1Sth Street Austin, TX 7S705 Joint Connnission # 8939 Emory University Hospital 110010 09/27/2017 GA Addendum XIV: Medicare-Approved Bariatric Surgery Facilities 1364 Clifton Road Atlanta, GA 30322 (October through December 2017) Joint Connnission # 6689 Addendum XIV includeww. ems. gov /MedicareApprovedF acilitie/B SF /list.asp# Thomas Jefferson University Hospital 390174 09/21/2017 PA 111 South 11th Street that meet minimum standards for facilities modeled in part on professional Philadelphia, PA 19107 society statements on competency. All facilities must meet our standards in Joint Connnission # 6132 order to receive coverage for bariatric surgery procedures. On February 21, FROM: Albert Einstein Medical 390142 09/20/2017 PA 3729 EN26JA18.028</GPH>

daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 BILLING CODE 4120–01–C [FR Doc. 2018–01475 Filed 1–25–18; 8:45 am] 3730 20:14 Jan 25, 2018 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices Jkt 244001 PO 00000 2006, vve issued our decision memorandum on bariatric surgery procedures. for bariatric surgery that have been certified by ACS and/or ASMBS in the Frm 00058 We determined that bariatric surgical procedures are reasonable and 3-month period. This information is available at necessary for Medicare beneficiaries who have a body-mass index (BMI) www. ems. gov/MedicareApprovedF acilitie/B SF/list.asp#TopOfPage. For greater than or equal to 35, have at least one co-morbidity related to obesity questions or additional infonnation, contact Saral1 Fulton, MHS and have been previously unsuccessful 'vith medical treatment for obesity. (410-786-2749). Fmt 4703 Tiris decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) Addendum XV: FDG-PET for Dementia and Neurodegenerative certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Diseases Clinical Trials (October through December 2017) Sfmt 9990 Surgery Center (program standards and requirements in effect on February There were no FDG-PET for Dementia and Neurodegenerative 15, 2006); or (2) certified by the American Society for Bariatric Surgery Diseases Clinical Trials published in the 3-month period. (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program This information is available on our website at E:\FR\FM\26JAN1.SGM standards and requirements in effect on February 15, 2006). www. ems. gov/MedicareApprovedF acilitie/PETDT/list.asp#TopOfPage. There were no additions, deletions, or editorial changes to For questions or additional information, contact Stuart Caplan, RN, MAS Medicare-approved facilities that meet CMS 's minimum facility standards (410-786-8564 ). 26JAN1 EN26JA18.029</GPH>


Document Created: 2018-10-26 10:05:35
Document Modified: 2018-10-26 10:05:35
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.
FR Citation83 FR 3716 
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