Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2017, 3716-3730 [2018-01475]

Download as PDF 3716 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices daltland on DSKBBV9HB2PROD with NOTICES panel meeting and the transition to one meeting of the panel per year (81 FR 31941). II. Request for Nominations; Criteria for Nominees The Panel shall consist of a chair and up to 15 members who are full-time employees of hospitals, hospital systems, or other Medicare providers that are subject to the OPPS. For supervision deliberations, the Panel shall also include members that represent the interests of Critical Access Hospitals (CAHs), who advise the Centers for Medicare & Medicaid Services (CMS) only regarding the level of supervision for hospital outpatient therapeutic services. (For purposes of the Panel, consultants or independent contractors are not considered to be fulltime employees in these organizations.) The HOP Panel currently consists of 13 panel members. Two additional vacancies will occur in CY 2018. The list of HOP Panel members is located in the FACA database, Advisory Panel on Hospital Outpatient Payment Committee page, on the FACA database website at: https://www.facadatabase.gov/ committee/committee.aspx?cid= 1791&aid=76. Panel members serve on a voluntary basis, without compensation, according to an advance written agreement; however, for the meetings, CMS reimburses travel, meals, lodging, and related expenses in accordance with standard Government travel regulations. CMS has a special interest in ensuring, while taking into account the nominee pool, that the Panel is diverse in all respects of the following: Geography; rural or urban practice; race, ethnicity, sex, and disability; medical or technical specialty; and type of hospital, hospital health system, or other Medicare provider subject to the OPPS. Appointment to the HOP Panel shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. Based upon either self-nominations or nominations submitted by providers or interested organizations, the Secretary, or his or her designee, appoints new members to the Panel from among those candidates determined to have the required expertise. New appointments are made in a manner that ensures a balanced membership under the FACA guidelines. This notice requests nominations for HOP Panel members on a continuous basis. Nominations for a person not serving on the committee may be reconsidered as committee vacancies arise, but should be updated VerDate Sep<11>2014 20:14 Jan 25, 2018 Jkt 244001 and resubmitted no later than 3 years after the original nomination submittal to continue to be considered for committee vacancies. CMS will consider the nominations submitted in response to the notice published in the Federal Register on December 23, 2016, entitled ‘‘Medicare Program; Renewal of the Advisory Panel on Hospital Outpatient Payment and Solicitation of Nominations to the Advisory Panel on Hospital Outpatient Payment’’ (81 FR 94378), unless they are withdrawn or the nominees’ qualifications have changed. Nominations will be considered as vacancies occur. The Panel must be balanced in its membership in terms of the points of view represented and the functions to be performed. Each panel member must be employed full-time by a hospital, hospital system, or other Medicare provider subject to payment under the OPPS (except for the CAH members, since CAHs are not paid under the OPPS). All members must have technical expertise to enable them to participate fully in the Panel’s work. Such expertise encompasses hospital payment systems; hospital medical care delivery systems; provider billing systems; APC groups; Current Procedural Terminology codes; and alpha-numeric Health Care Common Procedure Coding System codes; and the use of, and payment for, drugs, medical devices, and other services in the outpatient setting, as well as other forms of relevant expertise. For supervision deliberations, the Panel shall have members that represent the interests of CAHs, who advise CMS only regarding the level of supervision for hospital outpatient therapeutic services. It is not necessary for a nominee to possess expertise in all of the areas listed, but each must have a minimum of 5 years of experience and currently have full-time employment in his or her area of expertise. Generally, members of the Panel serve overlapping terms up to 4 years, based on the needs of the Panel and contingent upon the rechartering of the Panel. A member may serve after the expiration of his or her term until a successor has been sworn in. Any interested person or organization may nominate qualified individuals. Self-nominations will also be accepted. Each nomination must include the following: • Letter of Nomination stating the reasons why the nominee should be considered. • Curriculum vitae or resume of the nominee that includes an email address where the nominee can be contacted. • Written and signed statement from the nominee that the nominee is willing PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 to serve on the Panel under the conditions described in this notice and further specified in the Charter. • The hospital or hospital system name and address, or CAH name and address, as well as all Medicare hospital and or Medicare CAH billing numbers of the facility where the nominee is employed. Future updates or changes to the panel nomination process may be published in the Federal Register or posted on the CMS Advisory Panel for Hospital Outpatient Payment website, referenced in section II, ‘‘Request for Nominations; Criteria for Nominees,’’ of this notice. IV. Copies of the Charter To obtain a copy of the Panel’s Charter, we refer readers to our website at: https://www.cms.gov/Regulationsand-Guidance/Guidance/FACA/ AdvisoryPanelonAmbulatoryPayment ClassificationGroups.html. V. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Dated: January 12, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2018–01474 Filed 1–25–18; 8:45 am] BILLING CODE 4120–01–P 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 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: 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. SUMMARY: E:\FR\FM\26JAN1.SGM 26JAN1 3717 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices It is possible that an interested party may need specific information and not be able to determine from the listed FOR FURTHER INFORMATION CONTACT: 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. Addenda Contact I. CMS Manual Instructions ...................................................................................................... II. Regulation Documents Published in the Federal Register .................................................. III. CMS Rulings ....................................................................................................................... IV. Medicare National Coverage Determinations ..................................................................... V. FDA-Approved Category B IDEs ......................................................................................... VI. Collections of Information ................................................................................................... VII. Medicare-Approved Carotid Stent Facilities ...................................................................... VIII. American College of Cardiology-National Cardiovascular Data Registry Sites ............... IX. Medicare’s Active Coverage-Related Guidance Documents ............................................. X. One-time Notices Regarding National Coverage Provisions .............................................. XI. National Oncologic Positron Emission Tomography Registry Sites .................................. XII. Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities ............... XIII. Medicare-Approved Lung Volume Reduction Surgery Facilities ...................................... XIV. Medicare-Approved Bariatric Surgery Facilities ............................................................... XV. Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ....................... All Other Information ................................................................................................................ Ismael Torres .......................... Terri Plumb ............................. Tiffany Lafferty ........................ Wanda Belle, MPA ................. John Manlove ......................... William Parham ....................... Sarah Fulton, MHS ................. Sarah Fulton, MHS ................. JoAnna Baldwin, MS .............. JoAnna Baldwin, MS .............. Stuart Caplan, RN, MAS ........ Linda Gousis, JD .................... Sarah Fulton, MHS ................. Sarah Fulton, MHS ................. Stuart Caplan, RN, MAS ........ Annette Brewer ....................... I. Background daltland on DSKBBV9HB2PROD with NOTICES 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 VerDate Sep<11>2014 20:14 Jan 25, 2018 Jkt 244001 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’’ PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Phone No. (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) 786–1864 786–4481 786–7548 786–7491 786–6877 786–4669 786–2749 786–2749 786–7205 786–7205 786–8564 786–8616 786–2749 786–2749 786–8564 786–6580 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 https:// www.cms.gov/manuals. Dated: January 17, 2018. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–P E:\FR\FM\26JAN1.SGM 26JAN1 daltland on DSKBBV9HB2PROD with NOTICES 3718 VerDate Sep<11>2014 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Addendum 1: Medicare and Medicaid Manual Instructions (October through December 2017) The CMS Manual System is used by CMS program components, partners, providers, contractors, Medicare Advantage organizations, and State Survey Agencies to administer CMS programs. It offers day-to-day operating instructions, policies, and procedures based on statutes and regulations, guidelines, models, and directives. In 2003, we transformed the CMS Program Manuals into a web user-friendly presentation and renamed it the CMS Online Manual System. Sfmt 4725 E:\FR\FM\26JAN1.SGM 26JAN1 How to Obtain Manuals The Internet-only Manuals (IOMs) are a replica of the Agency's official record copy. Paper-based manuals are CMS manuals that were officially released in hardcopy. The majority of these manuals were transferred into the Internet-only manual (10M) or retired. Pub 15-1, Pub 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 only. If you notice policy contained in the paper-based manuals that was not transferred to the 10M, send a message via the CMS Feedback tool. Those wishing to subscribe to old versions of CMS manuals should contact the National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-6050). You can download copies of the listed material free of charge at: https://cms.gov/manuals. How to Review Transmittals or Program Memoranda Those wishing to review transmittals and program memoranda can access this information at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have EN26JA18.017</GPH> arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. This information is available at https://www.gpo.gov/libraries/ In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most federal government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing entitled Medicare and Medicaid Manual Instructions. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the manual for January 2018 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files use (CMS-Pub. 100-04) Transmittal No. 3878. Addendum I lists a unique CMS transmittal number for each instruction in our manuals or program memoranda and its subject number. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manual. For the purposes of this quarterly notice, we list only the specific updates to the list of manual instructions that have occurred in the 3-month period. This information is available on our website at www.cms.gov/Manuals. Transmittal Number lcl~!i:';"''I;,) lOS ! i\;~\~?'\'i Manual/Subject/Publication Number '·'' ·'"·'''\i);;;;A;);<:~'i·< Transition Workload Handbook Fee-for-Service Contractor Workload Transitions Transition Handbooks 109 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Affordable Care Act Bundled Payments for Care Improvement Initiative 110 Recurring File Updates Models 2 and 4 April2018 Updates 111 Update to Medicare Deductible, Coinsurance and Premium Rates for 2018 Basis for Determining the Part A Coinsurance Amounts Part B Annual Deductible Part B Premium ;:,c;;ss:•;< <::l.li:';•:,,>; ·;,:<•·;;. } ;~: i ~i\ ~~~·'t:!{ 1,'''~(·~'''2)c~';> 228 Internet Only Manual Updates to Pub. 100-0 L 100-02 and 100-04 to Correct Errors and Omissions (SNF Requirements - General Medicare S'IF PPS Overview Medicare S'IF Coverage Guidelines Under PPS Hospital Providers of Extended Care Services Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 20:14 Jan 25, 2018 Publication Dates for the Previous Four Quarterly Notices We publish this notice at the end of each quarter reflecting information released by CMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: February 23, 2017 (82 FR 11456), May 5, 2017 (82 FR 21241), August 4, 2017 (82 FR 36404) and October 27, 2017 (82 FR 49819). We arc providing only the specific updates that have occurred in the 3-month period along with a hyperlink to the website to access this information and a contact person for questions or additional information. daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Jkt 244001 230 PO 00000 Frm 00047 Fmt 4703 Sfmt 4725 E:\FR\FM\26JAN1.SGM 26JAN1 Service Requirements for Visiting Nursing Services 231 232 233 234 235 236 237 Treatment Plans Hospice Services Hospice Attending Practitioner Provision of Services to Hospice Patients in a RHC or FQHC Preventive Health Services Preventive Health Services in RHCs Preventive Health Services in FQHCs Copayment for FQHC Preventive Health Services Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2017 January 2017 Cpdate of the Hospital Outpatient Prospective Payment System (OPPS) Covered Inpatient Hospital Services Covered Under Part A Clarification of Payment Policy Changes for Negative Pressure Wound Therapy (NPWT) Using a Disposable Device and the Outlier Payment Methodology for Home Health Services Table of Contents National60-Day Episode Rate Outlier Payments Consolidated Billing Patient Confined to the Home Sequence of Qualitying Services and Other Medicare Covered Home Health Services Needs Skilled Nursing Care on an Intermittent Basis (Other than Solely Venipuncture for the Purposes of Obtaining a Blood Sample), Physical Therapy, Speech-Language Pathology Services, or Has Continued Need for Occupational T11erapy Physician Certification Supporting Documentation Requirements Wound Care Medical Supplies (Except for Drugs and Biologicals Other Than Covered Osteoporosis Drugs), the Use of Durable Medical Equipment and Furnishing Negative Pressure Wound Therapy Using a Disposable Device Negative Pressure Wound Therapy Using a Disposable Device Coinsurance, Copayments, and Deductibles Clarification of Admission Order and Medical Review Requirements Table of Contents Covered Inpatient Hospital Services Covered Under Part A Hospital Inpatient Admission Order and Certification Removal of Contractor Requirement to Submit Opt Out Data into the Contractor Reporting of Operational and Workload Data (CROWD) System (Form 8) Medicare l:lenetlt Policy Manual - Chapter 10, Ambulance Locality and Advanced Life Support (ALS) Assessment Locality Ground Ambulance Services Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidnev Iniurv (AKI) in ESRD Facilities for Calendar Year (CY) 2018 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 20:14 Jan 25, 2018 229 Three- Day Prior Hospitalization 'lhree-Day Prior Hospitalization- Foreign Hospital Effect on Spell of Illness Medical Service of an Intern or Resident-in-Training Medical and Other Health Services Furnished to SNF Patients Services Furnished Under Arrangements With Providers Definition of Durable Medical Equipment Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2017 Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Updates Table of Contents Index of Acronyms RHC General Information FQHC General Information RHC Staffing Requirements RHC Temporary Staffing Waivers RHC and FQHC Visits Multiple Visits on Same Day 3-Day Payment Window RHC Services FQHC Services Emergency Services Non RHC!FQHC Services Description of Non RHC/FQHC Services RHC Payment Rate RHC Payment Limit and Exceptions Payment Codes for FQHCs Billing Under the PPS FQHC PPS Payment Rate and Adjustments FQHC Payment Codes RHC and FQHC Cost Report Requirements RHC and FQHC Cost Report Forms RHC and FQHC Charges, Coinsurance, Deductible, and Waivers Comminglin Dental, Podiatry, Optometry, and Chiropractic Services Graduate Medical Education Transitional Care Management (TCM) Services Chronic Care Management (CCM) Services Services and Supplies Furnished "Incident to" Physician's Services Provision oflncident to Services and Supplies Incident to Services and Supplies Furnished in the Patient's Home or Location Other than the RHC or FQHC Payment to Physician Assistants Services and Supplies Furnished Incident to NP, P A, and CNM Services Services and Supplies Incident to CP Services Mental Health Visits Physical Therapy, Occupational Therapy, and Speech Language Pathology 3719 EN26JA18.018</GPH> daltland on DSKBBV9HB2PROD with NOTICES 3720 VerDate Sep<11>2014 238 Jkt 244001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4725 E:\FR\FM\26JAN1.SGM 203 26JAN1 ;i;<em ,:;.•:\/':;: :?::':\ ::; : ':fi,';.: ;•·,:;,~··~'.:c: ::,z:.::?:.:;t:.lk·t' 3872 Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2018 3873 Place of Service Codes 3874 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction 3875 Intemet Only Manual Update to Pub. 100-04, Chapter 16, to Update Clinical Lab Fee Schedule Layout 3876 Decommission the MCS Maintained HBCRB081 Report ("Correct Coding Quarterly Savings Report") Savings Report Savings Record Format 3877 3878 3879 3880 3881 3882 3883 3884 3885 3886 3887 3888 3889 3890 3891 3892 3893 3894 3895 3896 3897 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction January 2018 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Clinical Laboratory Fee Schedule l\ot Otherwise Classified, Not Otherwise Specified, or Unlisted Service or Procedure Code Data Collection Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Payment for Services Fumished by Qualified N onphysician Anesthetists Qualitled Nonphysician Anesthetist Services Entity or Individual to Whom Fee Schedule is Payable for Qualified N onphysician Anesthetists Anesthesia Fee Schedule Payment for Qualified Nonphysician Anesthetists Conversion Factors Used for Qualified Nonphysician Anesthetists Conversion Factors for Anesthesia Services of Qualified Nonphysician Anesthetists Fumished on or After January 1, 1992. Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Fiscal Year (FY) 2018 Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) PPS Changes Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity oflnstruction Issued to a specitlc audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instmction Issued to a specific audience, not posted to Intcmct/Intranct due to Confidentiality of Instruction Issued to a specitlc audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Issued to a specific audience, not posted to Intcmct/Intranct due to Confidentiality oflnstruction Ambulance Inflation Factor for CY 2018 and Productivity Adjustment Ambulance Inflation Factor (AIF) File Conversions Related to the Spanish Translation of the Healthcare Common Procedure Coding System (HCPCS) Descriptions Issued to a specific audience, not posted to Intcmct/Intranct due to Sensitivity oflnstruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Pulmonary Rehabilitation (PR) Services Addition to Chapter 19, Indian Health Services (IHS) Pulmonarv Rehabilitation, Physical Therapy, Occupational Therapy, Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 20:14 Jan 25, 2018 EN26JA18.019</GPH> l.::cc;:,;;,c.;;•·;c:::•: Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Medicare Benefit Policy Manual Chapter l3 Update Treatment Plans or Home Care Plans Graduate Medical Education Services and Supplies Furnished "Incident to" Physician's Services Provision of Incident to Services and Supplies Incident to Services and Supplies Furnished in the Patient's Home or Location Other than the RHC or FQHC Payment for Incident to Services and Supplies Nurse Practitioner, Physician Assistant, and Certified Nurse Midwife Services Payment to Physician Assistants Services and Supplies Furnished Incident to NP, P A, and CNM Services Clinical Psychologist and Clinical Social Worker Services Services and Supplies h1cident to CP Se1vices Mental Health Visits Physical Therapy, Occupational Therapy, and Speech Language Pathology Services Description of Visiting Nursing Services Requirements for Visiting Nursing Services Home Health Agency Shortage Area Treatment Plans Telehealth Services Hospice Attending Practitioner Provision of Services to Hospice Patients in an RHC or FQHC Preventive Health Services in RHCs Copayment and Deductible for RHC Preventive Health Services Preventive Health Services in FQHCs Copaymcnt for FQHC Preventive Health Service Care Management Services Transitional Care Management Services General Care Management Services - Chronic Care Management and General Behavioral Health Integration Services D. Collaborative Care Model Services ~i·~~~;~:~;j~ Hyperbaric Oxygen (liDO) Therapy (Section C, Topical Application of OJ<:ygen) Hyperbaric Oxygen Theiapy daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Jkt 244001 3899 3900 3901 PO 00000 3902 3903 Frm 00049 3904 3905 Fmt 4703 1906 Sfmt 4725 3908 3907 E:\FR\FM\26JAN1.SGM 1909 3910 3911 3912 26JAN1 3913 3914 1915 3916 3917 3918 3919 1920 3921 3922 3923 3924 3925 3926 3927 3928 3929 3930 3931 3932 Therapy Cap Values for Calendar Year (CY) 2018 Update to Rural Health Clinic (RHC) All Inclusive Rate (AIR) Payment Limit for Calendar Year (CY) 2018 Qualified Medicare Beneficiary Indicator in the Medicare Fee-For-Service Claims Processing System Hyperbaric Oxygen (liDO) Therapy (Section C, Topical Application of Ox-ygen) Update to the Federally Qualified Health Center (FQHC) Prospective Payment System (PPS) for Calendar Year (CY) 2018- Recurring File Update Quarterly Update ofHCPCS Codes Used for Home Health Consolidated Billing Enforcement 2018 Annual Update to the T11erapy Code List Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2018 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Instructions for Downloading the Medicare ZIP Code File for April 2018 OIT-Cyde Update to the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Fiscal Year (FY) 2018 Pricer Elimination of the GT .\i!odifier for Telehealth Services Hospice Manual Update Only for Section 30.3 Data Required on the Institutional Claim to AlB MAC (HHH Hospice Pricer Program Input/Output Record Layout Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction H' for Immunosuppressive Drugs Special ":i:-~<.·~;~;.~;.~;~}~:~;;:•.;~ ~~" None :&·:~:,;·:.;;•.\1:):{;:y;; . $;-~~\~·~;·~t~t.\.c;J~\::):.~·; (k;;;::.:i~iJ;~.\,.,l.; ;·;:: 295 :::;;·~-ili~·:~:,·:,t••· 171 172 173 174 175 176 •.:i\:"c,':: ••l~::;\';'.'i;•\; ':i\' ::; Notice of 'lew Interest Rate for Medicare Overpayments and Underpayments -1st Qtr. Notification for FY 2018 :''•;((i~;•<:ii•~•.: iSic.1:: Revisions to State Operations .\i!anual (SOM), Appendix U - Survey Procedures and Interpretive Guidelines for Responsibilities of Medicare Participating Religious Nonmedical Health care Institutions Revision to State Operations Manual (SOM) Appendix A- Survey Protocol, Regulations and Interpretive Guidelines for Hospitals Revisions to State Operation Manual (SOM), Appendix PP Guidance to Surveyors for Long Term Care Facilities Revisions to the State Operations Manual (SOM) Appendix P Revisions to State Operations Manual (SOM) Appendix J, Part IIInterpretive Guidelines -Responsibilities of Intermediate Care Facilities for Individuals with Intellectual Disabilities Revisions to State Operations Manual (SOM) Appendix A- Survey Protocol, Regulations and Interpretive Guidelines for Hospitals Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 20:14 Jan 25, 2018 3898 Speech-Language Pathology and Diagnostic Audiology Services- Payment Policy Pulmonarv Rehabilitation Services - Claims Processing Correction to Prevent Payment on Inpatient Information Only Claims for Beneficiaries Enrolled in Medicare Advantage Plans Claims Processing Requirements for TAVR Services for Medicare Advantage (MA) Plan Participants Claims Processing Requirements for TMVR for MR Services for Medicare Advantage (MA) Plan Participants Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Update to Pub 100-04, Chapter 18 Preventive and Screening Services Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) New Waived Tests Annual Medicare Physician Fee Schedule (MPFS) Files Delivery and Implementation and Medicare Physician Fee Schedule Database (MPFSDR) 2018 File Layout Manual Addendum Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction October 2017 Integrated Outpatient Code Editor (I!OCE) Specifications Version 18.3 Influenza Vaccine Payment Allowances - Annual Update for 2017-2018 Season Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) - January 2018 Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easv Print (MREP) and PC Print Update New Positron Emission Tomography (PET) Radiopharmaceutical/Tracer Unclassified Codes Off-Cycle Update to the Long Term Care Hospital (LTCH) Prospective Payment System (PPS) Fiscal Ycar (FY) 2018 Pricer Common Edits and Enhancements Modules (CEM) Code Set Update Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Implement Operating Rules- Phase Ill Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): CORE 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule- Update from Council for Affordable Quality Healthcare (CAQH) Committee on Operating Rules for Information Exchange (CORE) Claim Status Category and Claim Status Codes Update Calendar Year (CY) 2018 Participation Enrollment and Medicare Participating Physicians and Suppliers Directorv (MEDP ARD) Procedures 3721 EN26JA18.020</GPH> daltland on DSKBBV9HB2PROD with NOTICES 3722 VerDate Sep<11>2014 t;1\ii}5~~ ;,ji{;\·~~i:;·;c,.: 747 Jkt 244001 749 750 PO 00000 Frm 00050 751 752 Fmt 4703 753 754 Sfmt 4725 755 None I~ :i>l;~i;~~; .•·; ;• E:\FR\FM\26JAN1.SGM 1;;,•*'·:' None li;.·,..·ll\~l''\;i) .......... ,;,, •. ,,,..,. None 12;•.;;\~):~.f;x,,•• 26JAN1 None 1~·;'. ;;5;\~}?~1 180 183 184 185 ::SI.':'t''''<' ' ·\,• '''· 1928 1929 1930 1931 1932 1933 1934 '•'S7'; 1935 1936 1?¥F>t';~; '(:•·•.;\s,;~\ None ),\::;\';$) None 1~'\:k'.'·'' .. 186 187 :;}:'i'\\\ ~'xt·~:,,:,; 1937 1938 1939 .. . ;1•.\ ;. 1940 : '''''"'' :vC,'' '" c,·, 1941 t:;'<t····~ ~ ·~~·: ~~~\: •; U.i!7 t\%:.>~£''1 ,' :;;·:/~!;''• Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instmction Next Generation ACO Model- Weekly AIPBP Reduction File Change Issued to a specific audience, not posted to Intcrnct/Intranct due to Sensitivity of Instmction Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instmction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity ofTnstmction Demonstration: Payment Update for 2018 1942 1943 1944 1945 1946 IVIG Demonstration: Payment Update for 2018 Next Generation Accountable Care Organization (NGACO) Year Three Benefit Enhancements ~~)'\,{,·,0~.;,:;~~; ,;~; 01:\~i' ~~"·1';">'" Multi-Carrier System (MCS), Fiscal Intermediary Shared System (FISS) and VIPS Medicare Shared System (VMS) Automation of Prior Authorization (PA) Requests/Pre-Claim Reviews (PCR) and their Responses with Multiple Services (for programs like Home Health (HH)) via the Electronic Submission of Medical Documentation (esMD) System CMS Approved Review Topics for Durable Medical Equipment, Prosthetic, Orthotics, Supplies (DMEPOS) National Provider Identification Crosswalk System (NPICS) Retirement Analysis Only- Engage Shared Systems Mainlainers (SSMs) and Medicare Administrative Contractors (MACs) in Meetings and Correspondence Related to the NPICS Retirement with the Integrated Data Repository (!DR) Team Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instmction Shared System Enhancement 2015: Identify Inactive Medicare Demonstration Projects within the Fiscal Intermediary Shared System - Removing/Archiving demonstration codes 38, 42 and 43) Shared System Enhancement 2015: Identify Inactive Medicare Demonstration Projects within the Fiscal Intermediary Shared System - Removing/Archiving demonstration codes 38, 42 and 43) Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instmction FIS S Process Enhancements - Analysis Only Modifications to the National Coordination of Benefits Agreement (COBA) Crossover Process Provider Education and Referral Reporting Archiving National Provider Identifier Crosswalk System (NPICS) System Logic in the Durable Medical Equipment (DME) Claims Processing System l'iscal Intem1ediary Shared Systems (!'ISS) Enhancements to the Mass Adjustment of Process Recovery Audit Contractor (RAC) Claims Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instmction Transitional Dmg Add-on Payment Adjustment (TDAPA) for patients with Acute Kidney Injury (AKI) Common Working File (CWF) to Medicare Beneficiary Database (MBD) Extract File Changes for Detailed Skilled l\ursing Facility Data to Suppmt HIP AA Eligibility Transaction System (HETS) Assign the Correct 935 Indicator on Adjustment Claims Submitted through the Provider Portal MCS Analysis Only: Undeliverable Medicare Summary Notices (lJMSNs)Beneficiary Do Not Forward Process Add Date of Receipt to the Beneficiary Data Streamlining (DDS) Part A Claims Layout Shared System Enhancement 2015: Removing/Archiving Obsolete Reports within the Multi-Carrier System (MCS) : Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 20:14 Jan 25, 2018 748 181 182 EN26JA18.021</GPH> :.~. .~~~.;);\:>;zi'F';i,'<*i\:''0\:\j' Update to Reporting Requirements Reconsideration Requests- Non-certified Providers/Suppliers External Reporting Requirements Defending Medical Review Decisions at Administrative Law Judge (ALJ) Hearings Election of Status Coordination of the AU Hearing Party in the AU Hearing The ALI Hearing Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instmction Proof of Delivery Documentation Requirements Supplier Proof of Delivery Documentation Requirements Proof of Delivery and Delivery Methods Proof of Delivery Requirements for Recently Eligible Medicare FFS Beneficiaries Supplier Documentation Clarifying Signature Requirements Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instmction Certificates of Medical Necessity (CMN) and Durable Medical Equipment (DME) Information Forms (DIF) Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instmction Tracking Medicare Contractors' Prepayment and Postpayment Reviews daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 1947 1949 1950 Jkt 244001 1951 PO 00000 I953 1952 1954 Frm 00051 1955 1956 Fmt 4703 1957 Sfmt 4725 1958 1959 E:\FR\FM\26JAN1.SGM 1960 1961 1962 26JAN1 1963 1964 1965 1966 1967 1968 1969 1970 Expert Claims Processing System (ECPS) - Analysis Only Modifications to the National Coordination of Benefits Agreement (COBA) Crossover Process Analysis Only: Develop Enhanced Claims Search Reporting in Fiscal Intermediary Shared Svstem (FISS) Multi-Carrier System (MCS) Modernization Proof of Concept Number 8 Revision of PWK (Paperwork) Fax/Mail Cover Sheets ICD-10 and Other Coding Revisions to National Coverage Determinations (NCDs) Common Working File (CWF) to Modify CWF Provider Queries to Only Accept National Provider Identifier (NPI) as valid Provider Number Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instruction Implementation of Changes to Certificate of Medical Necessity (CMN) and CMN DME Infonnation Form (Clv!N DIF) as a result of the New Medicare Card Project Shared System Enhancement 2015: Identify Inactive Medicare Demonstration Projects Within the Common Working File (CWF) Shared System Enhancement 2015: Removing/Archiving Obsolete On Request Jobs within the Multi-Carrier System (MCS) Fiscal Year (FY) 2014 and 2015 Worksheet S-10 Revisions: Further Extension for All Inpatient Prospective Payment System (IPPS) Hospitals Line Level versus Claim Level Reporting - Analysis Only Shared System Enhancement 2015: Identify Inactive Medicare Demonstration Projects within the Fiscal Intermediary Shared System- Removing/Archiving demonstration codes 38, 42 and 43) Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instruction 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 ::.;;~;~>:,~;,,,,; ;~.:b''\\.i 70 Issued to a specific audience, not posted to Intcmct/Intranct due to Confidentiality of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confirlentiality of Instmction 71 72 ;~;;l\,y;:~;··~:'''\· I None .·'·•'"'·:'•":05\i.::: Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 20:14 Jan 25, 2018 1948 Health Insurance Portability and Accountability Act (HIP AA) Electronic Data Interchange (EUI) Front End Updates for Aprii20IS Archiving National Provider Identifier Crosswalk System (NPICS) System Logic in the Muti-Carrier System (MCS) Remove Obsolete Edits from the Fiscal Intermediary Shared Systems (FISS) l'iscal Intem1ediary Shared System (I'ISS) and VIPS 'v!edicare Shared System (VMS) to Update Records Based on the Automation of Prior Authorization (P A) Requests/Pre-Claim Reviews (PCR) and their Responses with Multiple Services (for programs like Home Health (HH)) Shared System Enhancement 2015: Removing/Archiving Obsolete On Request Jobs within the Multi-Carrier System (MCS) Calculating Interim Rates for Graduate Medical Education (GME) Payments to New Teaching Hospitals Shared System Enhancement 20 I4: Implementation of Fiscal Intermediary Shared System (FISS) Obsolete On-Request Jobs- Phase I New Common Working File (CWF) Medicare Secondary Payer (MSP) Type forT ,iahility Medicare Set-Aside Arrangements (T ,!viSAs) and No-Fault Medicare Set-Aside Arrangements (NFMSAs) Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instruction Analysis and Design Working Sessions tor the Development of a PrePayment Common Additional Documentation Request (ADR) Letter Shared System Enhancement 2015: Identify Inactive Medicare Demonstration Projects Within the Common Working File (CWF)- Removing/Archiving Demonstration codes 51 and 56 Shared System Enhancement 2014: Implementation of Fiscal Intermediary Shared System (FISS) Obsolete Financial and Expert Claims Processing System (ECPS) Reports - Phase 1 Shared System Enhancement 2014: Implementation of Fiscal Intermediary Shared System (FISS) Obsolete Financial and Expert Claims Processing System (ECPS) Reports- Phase 1 Implementation of the Award for the Jurisdiction Part A and Part B Medicare Administrative Contractor (JJ AlB MAC) Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Shared System Enhancement 2014: Implementation of Fiscal Intermediary Shared System (FISS) Obsolete Core Reports- Phase 1 Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instruction Shared System Enhancement 2014: Implementation of Fiscal Intermediary Shared System (FISS) Obsolete Core Reports- Phase 1 Shared System Enhancement 2015: Resolve Operating Report (ORPT) Issues -Development and Implementation Out-of-Jurisdiction Providers (OJP) and Qualified Chain Providers (QCP) Move to Conect AlB MAC Jurisdiction - Analysis CR Only CICS Region Merge(s) for AlB MACs- Analysis Only Tracking Status of Claims Adjustments Partial Settlement of 2-Midnight Policy Court Cases Establish an Automated Process For Creating Mass Adjustments Utilizing 3723 EN26JA18.022</GPH> daltland on DSKBBV9HB2PROD with NOTICES 3724 VerDate Sep<11>2014 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4725 E:\FR\FM\26JAN1.SGM 26JAN1 Addendum III: CMS Rulings (October through December 2017) CMS Rulings arc decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. The rulings can be accessed at mq;.11 w ,, w. ~.:m~. t;uv 1f'-~:t;;m<muu::-.­ For questions or additional information, contact Tiffany Lafferty (410-786-7548). Addendum IV: Medicare National Coverage Determinations (October through December 2017) Addendum IV includes completed national coverage determinations (NCDs), or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCD Manual (NCDM) in which the decision appears, the EN26JA18.023</GPH> title, the date the publication was issued, and the effective date of the decision. An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII of the Act), but does not include a determination of the code, if any, that is assigned to a particular covered item or service, or payment determination for a particular covered item or service. The entries below include information concerning completed decisions, as well as sections on program and decision memoranda, which also announce decisions or, in some cases, explain why it was not appropriate to issue an NCD. Information on completed decisions as well as pending decisions has also been posted on the CMS website. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3month period. This information is available at: www.cms.gov/medicarecoverage-database/. For questions or additional information, contact Wanda Belle, MPA (410-786-7491). Title Hyperbaric Oxygen (HBO) Therapy (Section C, Topical Application of Oxygen) NCDM Section Transmittal Number Issue Date Effective Date NCD20.29 203 11117/2017 04/03/2017 Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (October through December 2017) Addendum V includes listings of the FDA-approved investigational device exemption (IDE) numbers that the FDA assigns. The listings are organized according to the categories to which the devices are assigned (that is, Category A or Category B), and identified by tl1e IDE number. For the purposes of this quarterly notice, we list only the specific updates to the Category BIDEs as of the ending date of the period covered by this notice and a contact person for questions or additional information. For questions or additional information, contact John Manlove (410-7866877). Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved investigational device exemption (IDE). Category A refers to experimental IDEs, and Category B refers to non-experimental IDEs. To obtain more infonnation about the classes or categories, please refer to the notice published in the April21, 1997 Federal Register (62 FR 19328). Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 20:14 Jan 25, 2018 Addendum II: Regulation Documents Published in the Federal Register (October through December 2017) Regulations and Notices Regulations and notices are published in the daily Federal Register. To purchase individual copies or subscribe to the Federal Register, contact GPO at www.gpo.gov/fdsys. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number. The Federal Register is available as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) through the present date and can be accessed at https://www.gpoaccess.gov/fr/. The following website https://www.archives.gov/federal-register/ provides information on how to access electronic editions, printed editions, and reference copies. This information is available on our website at: https://www. ems. govI quarterlyproviderupdates/downloads/Re gs4Ql7QPU.pdf For questions or additional information, contact Terri Plumb (410-786-4481 ). daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Jkt 244001 PO 00000 Gl70242 Frm 00053 Gl70247 Gl60196 Gl70248 Gl70252 Gl70251 Gl70179 Fmt 4703 Gl70261 Sfmt 4725 E:\FR\FM\26JAN1.SGM Gl70189 Gl70254 Gl70257 Gl70258 Gl70083 Gl70219 Gl70205 Gl70268 Gl70270 Gl70273 26JAN1 Gl70272 Gl70126 Gl70279 Gl70282 Gl70283 Device Medtronic IN.P ACT Admiral Drug-Coated Balloon Gel-Bead embolization spheres Strattice Reconstructive Tissue Matrix DiamondTemp Ablation Svstem LC BeadLUMI Exablate Model 4000 Type 1 Left Gastric Artery Embolization for Glycemic Control Axonics Sacral Neuromodulation System Doctormate Renqiao Remote Ischemic Conditioning Device Type IPC-906X A High-Performance ECoG-based "\Jeural Interface for Communication and Neuroprosthetic Control HiResolution Bionic Ear System Neovasc Reducer System ClonoSEQ in-vitro assay, laboratory developed test Trace IT Tissue Spacer Wingman Crossing Catheter SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System AXIOS Stent and Electrocautery Enhanced Delivery System lOmmxlOmm; AXIOS Stent and Electrocautery Enhanced Delivery System 15mmxl0mm;AXIOS Stent and Electrocautery Enhanced Delivery System 20mmx10mm Contour PV A, Embosphere and Embozene Wallstent SPRINT PNS System for the Treatment of Back Pain CardioME.Y!S HF System PQ Bypass System Cardio Flow Orbital Atherectomy System Brown Glaucoma Implant Activa PC+S Neurostimulation System; Neurostimulation Systems for Deep Brain Stimulation SurgiMed Meshed Collagen Matrix Medtronic Arctic Front Advance Cardiac Cryoballoon catheter Study of Left Main Coronary Artery Healing after PCI with Boston Scientific Synergy Bioabsorbable Polymer Stent (SOLbMN) MMS .Y!icroStent System Aries 2 Device SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System Cardioblate BP2, Cardioblate LP, Cardioblate Pen, Cardioblate XL Pen, Cardioblate MAPs; Cardioblate Generator; Cardioblate CryoFlex Probes and Clamp; Cardioblate CryoFlex Console Start Date 10/04/2017 10/04/2017 10/05/2017 10/06/2017 10/13/2017 10/20/2017 10/24/2017 10/27//2017 10/27/2017 10/27/2017 11102/2017 11/03/2017 11107/2017 11/07/2017 11/08/2017 11109/2017 11109/2017 11/14/2017 11/16/2017 1111712017 11/17/2017 11/20/2017 11/21/2017 11/22/2017 11124/2017 11/29/2017 11130/2017 12/01/2017 12/08/2017 12/08/2017 12/13/2017 IDE Gl50231 Gl60258 Gl702S6 Gl70287 Device Mayo Clinic Nerve Scaffold #1 (MCNSl) REZUM SYSTEM Transmural Transcaval Closure Device (Delivery System & Implant); Guidewire for use with Transcaval Closure Device Invisalign Palatal Expander Start Date 12/14/2017 12/15/2017 12115/2017 12/15/2017 Addendum VI: Approval Numbers for Collections of Information (October through December 2017) All approval numbers are available to the public at Reginfo.gov. Under the review process, approved information collection requests are assigned Ol'v!B control numbers. A single control number may apply to several related information collections. This information is available at www.reginfo.gov/public/do/PRAMain. For questions or additional information, contact William Parham (410-786-4669). Addendum VII: Medicare-Approved Carotid Stent Facilities, (October through December 2017) Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for perforrning carotid artery stenting for high risk patients. On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available at: https://www. ems. gov/MedicareApprovedFacilitie/CASF/list. asp#TopOfPage For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 20:14 Jan 25, 2018 IDE Gl70177 Gl70229 Gl70226 Gl70227 Gl70232 Gl70237 Gl70051 Gl70100 Gl70240 12/13/2017 3725 EN26JA18.024</GPH> daltland on DSKBBV9HB2PROD with NOTICES 3726 VerDate Sep<11>2014 r. :;~,~~;; ''i;~':.,,,s~ '' Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4725 E:\FR\FM\26JAN1.SGM 26JAN1 Good Samaritan Hospital Medical Center 1000 Montauk Highway Westlslip, NY 11795 Salt Lake Regional Medical Center 1050 E. South Temple Salt Lake City, UT 84102 1\i.•~\;·~~·;;.•.•;•i···· FROM: SSM St. Mary's Health Center TO: SSM Health StMary's Hospital - St. Louis 6420 Clayton Road Richmond Heights, MO 63117 FROM: DePaul Health Center TO: SSM Health DePaul Hospital -St. Louis 12303 DePaul Drive St. Louis, MO 63044-2588 FROM: SSM St. Clare Health Center TO: SSM Health St. Clare Hospital- Fenton 1015 Bowles Avenue Fenton, MO 63026 FROM: SSM St. Joseph Health Center TO: SSM Health St. Joseph Hospital - St Charles 300 First Capitol Drive St. Charles, MO 63301 FROM: Saint Louis University Hospital TO: SSM Health Saint Louis Uuiversity Hospital 3635 Vista at Grand Boulevard St. Louis, MO 63110 P.O. Box 15250 SSM-SLUH, INC FROM: StMary's Medical Center TO: St. Vincent Evansville 3700 Washington Avenue Evansville, IN 47740 FROM: Provena Mercy Medical Center TO: Presence Mercy Medical Center 1325 North Highland Avenue Provider Number Effective Date State 1902865355 10/20/2017 1417988833 12/1112017 26-0091 01112/2012 MO 26-0104 10/30/2009 MO 26-0081 01123/2006 MO 26-0005 04/26/2005 MO .·.;l.\';i ~ NY UT ,;;{(,':;\;;; '>'\!.!'!'<~''•'·. 26-0105 05/17/2005 MO 15-0100 05/17/2005 IN 140174 07/15/2005 IL Facility Aurora, IL 60506 FROM: Resurrection Medical Center TO: Presence Resurrection Medical Center 35 West Talcott Avenue Chicago, IL 60631 FROM: Provena Saint Joseph Hospital TO: Presence Saint Joseph Hospital 77 North Airlite Street Elgin, IL 60123-4912 FROM: Provena Saint Joseph Medical Center TO: Presence Saint Joseph Medical Center 333 North Madison Street Joliet, IL 60435-6595 FROM: Provena St. Mary's Hospital TO: Presence St. Mary's Hospital 500 West Court Street Kankakee. IL 6090 1 FROM: Tenet Hospital Limited TO: Baylor Scott & White Medical Center-White Rock 9440 Poppy Drive Dallas, TX 75218 FROM: Foote Hospital TO: Henry Ford Allegiance Health 205 North East Avenue Jackson, MI 49201 FROM: Rogue Valley Medical Center TO: Asante Rogue Regional Medical Center 2825 East Barnett Road Medford, OR 97504 Provider Number Effective Date State 140117 04/12/2005 IL 140217 05/1112005 IL 140007 09/06/2005 IL 140155 06/0112005 IL 450678 09/07/2007 TX 230092 11103/2005 MI 380018 05/05/2005 OR ;.;\~~~·~·:!.·;~zZ·t~~;~;.•;; Facility Lee's Summit Medical Center 2100 SE Blue Parkway T.ee's Summit, MO 64061 Provider Number 260190 r '"''''·c·•~·~:t~;;: r:\:~~i•'3: ~:.· ':••:.:s• Effective Date State 05/17/2005 MO Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 20:14 Jan 25, 2018 EN26JA18.025</GPH> Facility daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Addendum VIII: Jkt 244001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4725 E:\FR\FM\26JAN1.SGM 26JAN1 A provider can use either of two mechanisms to satisfy the data reporting requirement. Patients may be enrolled either in an Investigational Device Exemption trial studying ICDs as identified by the FDA or in the ACC-NCDR ICD registry. Therefore, for a beneficiary to receive a Medicare-covered ICD implantation for primary prevention, the beneficiary 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 registry can be found at www.ncdr.com/webncdr/common For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. Tlris infonnation is available by accessing our website and clicking on the link for the American College of Cardiology's National Cardiovascular Data Registry at: www.ncdr.com/webncdr/common. For questions or additional information, contact Sarah Fulton, MHS (410-786-27 49). ...•....... :)\\• City State Newton Alamogordo MA NM Forest Hills NY Lewiston ME Hattiesburg MS Dansville NY Omaha NE Mishawaka IN Shreveport LA Elkton MD Melbourne FL Grove OK <:•;~·~ Forest Hills Hospital Termination Requested Central Maine Medical Center Termination Requested--Please see case 00325173. We have consolidated ICD to PID 288750. Forrest General Hospital Service/Facility Closed--This facility had duplicate accounts. The ICD Registry was merged with PID 266955. Access to the ICD Registry for PID 656089 will cease 12/31117. Nicholas H. Noyes Memorial Hospital Termination Requested University Campus of CHI Health CUMCBergan Mercy Termination Requested St. Joseph Regional Medical Center- South Dend Termination Requested-- Please see case 00325200. We have consolidated the ICD registry to PID 663672. Willis Knighton Pierremont Termination Requested Union Hospital Termination Requested Melbourne Same Day Surgery Termination Requested Integris Grove Hospital Termination Requested--Please see case 00325232. We are consolidating the ICD Account to PID 334434 so all registries are under one account. •;:~,.~; ii\; j :;: Addendum IX: Active CMS Coverage-Related Guidance Documents (October through December 2017) CMS issued a guidance document on November 20, 2014 titled "Guidance for the Public, Industcy, and CMS Staff: Coverage with Evidence Development DocU111ent". Although CMS has several policy vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS' s implementation of coverage with evidence development (CED) through the Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 20:14 Jan 25, 2018 American College of Cardiology's National Cardiovascular Data Registry Sites (October through December 2017) Addendum VIII includes a list of the American College of Cardiology's National Cardiovascular Data Registry Sites. We cover implantable cardioverter defibrillators (ICDs) for certain clinical indications, as long as information about the procedures is reported to a central registry. Detailed descriptions of the covered indications are available in the NCD. In January 2005, CMS established the ICD Abstraction Tool through the Quality Network Exchange (QNet) as a temporary data collection mechanism. On October 27, 2005, CMS announced that the American College of Cardiology's National Cardiovascular Data Registry (ACC-NCDR) ICD Registry satisfies the data reporting requirements in the NCD. Hospitals needed to transition to the ACC-NCDR ICD Registry by April2006. Effective January 27, 2005, to obtain reimbursement, Medicare NCD policy requires that providers implanting ICDs for primary prevention clinical indications (that is, patients without a history of cardiac arrest or spontaneous arrhythmia) report data on each primary prevention ICD procedure. Details of the clinical indications that are covered by Medicare and their respective data reporting requirements arc available in the Medicare NCD Manual, which is on the CMS website at Facility Hospital Newton Wellesley Hospital Gerald Champion Regional Medical 3727 EN26JA18.026</GPH> daltland on DSKBBV9HB2PROD with NOTICES 3728 VerDate Sep<11>2014 Jkt 244001 PO 00000 Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (October through December 2017) There were no special one-time notices regarding national coverage provisions published in the 3-month period. This information is available at www.cms.hhs.gov/coverage. For questions or additional information, contact JoAnna Baldwin, MS (410-786 7205). Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\26JAN1.SGM 26JAN1 Addendum XI: National Oncologic PET Registry (NOPR) (October through December 2017) Addendum XI includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission tomography (PET) scans for particular oncologic indications when they are performed in a facility that participates in the NOPR. In January 2005, we issued our decision memorandum on positron emission tomography (PET) scans, which stated that CMS would cover PET scans for particular oncologic indications, as long as they were performed in the context of a clinical study. We have since recognized the National Oncologic PET Registry as one of these clinical studies. Therefore, in order for a beneficiary to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the registry. There were no additions, deletions, or editorial changes to the listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the 3-month period. This information is available at https://www.cms.gov/MedicareApprovedFacilitie/NOPR!list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (October through December 2017) Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (V ADs) used as destination therapy. All facilities were required to meet our standards in EN26JA18.027</GPH> order to receive coverage for VADs implanted as destination therapy. On October 1, 2003, we issued our decision memorandum on VADs for the clinical indication of destination therapy. We determined that V ADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for V ADs implanted as destination therapy. For the purposes of this quarterly notice, we are providing only the specific updates to the list of Medicare-approved facilities that meet our standards that have occurred in the 3-month period. This information is available at https://www. ems. gov/MedicareApprovedF acilitie!VAD/list.asp#TopOfPage. For questions or additional information, contact Linda Gousis, JD, (410-786-8616). Facility Provider Number Date Approved 320009 10/09/2017 NM 100080 01/25/2017 I'L 340040 09/27/2017 NC 040007 11122/2017 AR 370001 12/04/2017 OK 490063 07/26/2017 VA 100258 08/17/2017 FL .~Yi 5;5 Lovelace Medical Center 601 Dr. Martin Luther King Jr. Ave. NE Albuquerque, NM 87102 JI'K Medical Center 5301 South Congress Avenue Atlantis, FL 33462 Pitt County Memorial Hospital, Inc. d/b/a Vidant Medical Center 2100 Stantonsburg Road Greenville, NC 27834 CHI St. Vincent Heart Clinic 2 St. Vincent Circle Little Rock. AR 72205 Hillcrest Medical Center l120 S. Utica Tulsa, OK 74104 1;:.\; i';\';\?•;(\?i~.::~~i FROM: Inova Fairfax Hospital TO: Inova Fairfax Medical Campus 3300 Gallows Road Falls Church, VA 22042 Joint Commission# 6351 Delray Medical Center, Inc 5352 Linton Boulevard Delray Beach, FL 33484 Joint Commission# 5215 ;;:; ::\\it~;; State .::.>:: ,,.;c:•:,:o,':(,; Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 20:14 Jan 25, 2018 national coverage determination process. The document is available at https://www. ems. gov/medicare-coverage-database/details/medicarecoverage-document-details.aspx?MCDid=27. There are no additional Active CMS Coverage-Related Guidance Documents for the 3-month period. For questions or additional information, contact JoAnna Baldwin, MS (410-786-7205). daltland on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Facility Jkt 244001 Date Approved State Facility 08/09/2017 TX Center TO: Einstein Medical Center Philadelphia 5501 Old York Road Philadelphia, PA 19141 Joint Connnission # 6118 Lancaster General Hospital 555 North Duke Street Lancaster, P A 17602 Joint Connnission # 6086 PO 00000 Frm 00057 Fmt 4703 Sfmt 4725 E:\FR\FM\26JAN1.SGM 26JAN1 330101 09/24/2015 NY 460009 08/09/2017 UT 140281 08/19/2017 IL 670025 08/23/2017 TX 340047 08/19/2017 NC 100151 10/04/2017 FL 450021 11101/2017 TX 450056 10/04/2017 TX 110010 09/27/2017 GA 390174 09/21/2017 PA 390142 09/20/2017 PA Provider Number Date Approved State 390100 10/04/2017 PA Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices 20:14 Jan 25, 2018 UT Southwestern Medical Center/William P. Clements Jr. University Hospital 6201 Harry Hines Boulevard Dallas, TX 75390 Joint Connnission #9013. Hospital previously listed as St. Paul Medical Center. "ew York Presbyterian- Columbia University Medical Center 622 West 168th Street "ew York, NY 10032 Joint Connnission # 5838 University of Utah Hospital 50 N Medical Drive Salt Lake City, UT 84132 Joint Connnission # 9544 "orthwestern Memorial Hospital 251 E Huron Street Chicago, IL 60611 Joint Connnission # 7267 Texas Heart Hospital of the Southwest DBA The Heart Hospital Baylor Plano 1100 Allied Drive Plano, TX 75093 Joint Connnission # 440319 "mth Carolina Baptist Hospital DBA Wake Forest Baptist Medical Center .\i!edical Center Boulevard Winston Salem, NC 27157 .Joint Commission # 6571 .\i!ayo Clinic 4500 San Pablo Road Jacksonville, FL 32224 Joint Connnission # 369946 Baylor University Medical Center at Dallas 3500 Gaston Avenue Dallas, TX 75246 Joint Connnission # 8993 Seton Medical Center Austin 1201 W 1Sth Street Austin, TX 7S705 Joint Connnission # 8939 Emory University Hospital 1364 Clifton Road Atlanta, GA 30322 Joint Connnission # 6689 Thomas Jefferson University Hospital 111 South 11th Street Philadelphia, PA 19107 Joint Connnission # 6132 FROM: Albert Einstein Medical Provider Number 450044 Addendum XIII: Lung Volume Reduction Surgery (LVRS) (October through December 2017) Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (L VRS): • National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs); • Credentialed by the Joint Commission (formerly, the Joint Commision on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for L VRS; and • Medicare approved for lung transplants. Only the first two types are in the list. There were no updates to the listing of facilities for lung volume reduction surgery published in the 3-month period. This infonnation is available at www.cms.gov/MedicareApprww. ems. gov /MedicareApprovedF acilitie/B SF /list.asp#To questions or additional information, contact Sarah Fulton, MHS (410-786-27 49). Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (October through December 2017) Addendum XIV includeww. ems. gov /MedicareApprovedF acilitie/B SF /list.asp# that meet minimum standards for facilities modeled in part on professional society statements on competency. All facilities must meet our standards in order to receive coverage for bariatric surgery procedures. On February 21, 3729 EN26JA18.028</GPH> daltland on DSKBBV9HB2PROD with NOTICES 3730 PO 00000 Frm 00058 Fmt 4703 for bariatric surgery that have been certified by ACS and/or ASMBS in the 3-month period. This information is available at www. ems. gov/MedicareApprovedF acilitie/B SF/list.asp#TopOfPage. For questions or additional infonnation, contact Saral1 Fulton, MHS (410-786-2749). Sfmt 9990 E:\FR\FM\26JAN1.SGM Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (October through December 2017) There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the 3-month period. This information is available on our website at www. ems. gov/MedicareApprovedF acilitie/PETDT/list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). 26JAN1 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Notices Jkt 244001 [FR Doc. 2018–01475 Filed 1–25–18; 8:45 am] 20:14 Jan 25, 2018 BILLING CODE 4120–01–C VerDate Sep<11>2014 EN26JA18.029</GPH> 2006, vve issued our decision memorandum on bariatric surgery procedures. We determined that bariatric surgical procedures are reasonable and necessary for Medicare beneficiaries who have a body-mass index (BMI) greater than or equal to 35, have at least one co-morbidity related to obesity and have been previously unsuccessful 'vith medical treatment for obesity. Tiris decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006). There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS 's minimum facility standards

Agencies

[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Notices]
[Pages 3716-3730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

-----------------------------------------------------------------------

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.

[[Page 3717]]


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.

----------------------------------------------------------------------------------------------------------------
                  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
----------------------------------------------------------------------------------------------------------------

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 https://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
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