Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2014, 68253-68270 [2014-26989]

Download as PDF 68253 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2014, relating to the Medicare and Medicaid programs and other programs administered by CMS. FOR FURTHER INFORMATION CONTACT: It is possible that an interested party may need specific information and not be able to determine from the listed SUMMARY: Centers for Medicare & Medicaid Services [CMS–9087–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—July Through September 2014 Centers for Medicare & Medicaid Services (CMS), HHS. AGENCY: 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 ........................... John Manlove ......................... Mitch Bryman ......................... Lori Ashby .............................. Marie Casey, BSN, MPH ....... JoAnna Baldwin ...................... JoAnna Baldwin ...................... Stuart Caplan, RN, MAS ........ Marie Casey, BSN, MPH ....... Marie Casey, BSN, MPH ....... Jamie Hermansen .................. Stuart Caplan, RN, MAS ........ Annette Brewer ....................... mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 17:37 Nov 13, 2014 Jkt 235001 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 Web site or the appropriate data registries that are used as our resources. This information is the most current up-to-date information and will be available earlier than we publish our quarterly notice. We believe the Web site list provides more timely access for beneficiaries, providers, and suppliers. We also believe the Web site offers a more convenient tool for the public to find the full list of qualified providers for these specific services and offers more flexibility and ‘‘real time’’ 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 786–5258 786–6322 786–7861 786–7205 786–7205 786–8564 786–7861 786–7861 786–2064 786–8564 786–6580 accessibility. In addition, many of the Web sites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the Web site. These listservs avoid the need to check the Web site, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a Web site proves to be difficult, the contact person listed can provide information. III. How To Use the Notice This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at https:// www.cms.gov/manuals. Dated: November 7, 2014. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–P E:\FR\FM\14NON1.SGM 14NON1 mstockstill on DSK4VPTVN1PROD with NOTICES 68254 VerDate Sep<11>2014 Jkt 235001 PO 00000 Frm 00046 Fmt 4703 Addendum 1: Medicare and Medicaid Manual Instructions (July through September 2014) 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\14NON1.SGM 14NON1 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 IOM, 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 (703605-6050). You can download copies of the listed material free of charge at:==--"-'-'="'-"-'--'-==="'· 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 EN14NO14.001</GPH> designated libraries throughout the United States. Some FDLs may have 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==~~,_,.~;:;.~=~=~~ 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 infonnation 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 Cardiac Rehabilitation Programs for Chronic Heart Failure use CMS-Pub. 100-03, Transmittal No. 171. 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 usc 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.!!.!=~,~~~~~~~· Transmittal Nnmber 1~~~?;'·... ~~~~~s;~ ~;i 87 88 r'~ vl<,i&:\;,,~~::;;i 190 191 192 Manual/Subject/Publication Number i$ \~~ ~ i :''~h i:C' ~.cf'~ Update to Pub. 100-0 I, Chapter 7 for language-Only Changes Jor !CD I 0 Test Case Specification Standard Rescinds/Replaces CR 7468- Updated Instructions for the Change Request Implementation Report (CRIR) and Technical Direction Letter (TDL) Compliance Report (TCR) Sample Cover Letter/Attestation Statement CR Implementation Report (CRJR) Template TDL Compliance Report (TCR) Template Contractor Implementation of Change Requests and Compliance with Technical Direction letters ,,,,~. z, ;; >· ~~"' ~~~~~i~,~!iS ~;;' 'ts::'§C:;i,~~;roj: Beneficiary Signature Requirements tor Ambulance Services Cardiac Rehabilitation Programs for Chronic Heart Failure Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR) Services Furnished On or After January I, 2010 Clarilication of the Contined to the Home Definition in Chapter 15, Covered Mt:dkal and Other Health Scrvi<:t:s, uftl11: Meui<.:are Benefit Polky Manual Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 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: November 8, 2013 (78 FR 67153), January 31,2014 (79 FR 5419), April25, 2014 (79 FR 22976) and July 25,2014 (79 FR 43475). For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period along with a hypcrlink to the website to access this information and a contact person for questions or additional information. mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 193 Jkt 235001 194 PO 00000 Frm 00047 Fmt 4703 195 Sfmt 4725 .••• ii:'~;,, ~:£,;; 170 E:\FR\FM\14NON1.SGM 171 172 173 .ij.{\i;;~ ~. ;t~A~·~•ii~.>'f:~j.y•.• 14NON1 National Coverage Determination (NCO) for Single Chamber and Dual Chamber Permanent Cardiac Pacemakers Cardiac Rehabilitation Programs for Chronic Heart Failure Ventricular Assist Devices for Bridge-to-Transplant and Destination Artificial Hearts and Related Devices (Various Etrective Dates Below) Ventricular Assist Devices (Various Effective Dates Below) Therapy Pub 100-03, Chapter I, language-only update Foreword- Purpose for National Coverage Determinations (NCD) Manual Cse of Visual Tests Prior to and General Anesthesia During Cataract Surgery Transcutaneous Electrical Nerve Stimulation (TENS) for Acute PostOperative Pain Outpatient Hospital Pain Rehabilitation Programs Anesthesia in Cardiac Pacemaker Surgery Percutaneous Transluminal Angioplasty (PTA) (Various Effective Dates Below) Cardiac Pacemakers (Various Effective Dates) Cardiac Pacemaker Evaluation Servkes Transtelephonic Monitoring of Cardiac Pacemakers Electrocardiographic Services Cardiac Output Monitoring By Thoracic Electrical Bioimpcdance (TEB)Various Effective Dates Below Speech Generating Devices Cochlear Implantation (Effective April4, 2005) Physician's Office Within an Institution- Coverage of Services and Supplies Incident to a Physician's Services Abarelix for the Treatment of Prostate Cancer (Etrective March 15, 2005) Hydrophilic Contact Lens for Corneal Bandage Photodynamic Therapy Ocular Photodynamic Therapy (OPT)- Effective April 3, 20 13) Photosensitive Drugs Verteportin- Effective April3, 2013 Hydrophilic Contact Lenses Laproscopic Cholecystectomy Certain Drugs Distributed by the National Cancer Institute Stem Cell Transplantation (Various Effective Dates Below Anticancer Chemotherapy for Colorcctal Cancer (Effective January 28, 2005) Hospital and Skilled Nursing Facility Admission Diagnostic Procedures Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions Inpatient Hospital Stays for the Treatment of Alcoholism Chemical Aversion Therapy tor Treatment of Alcoholism Treatment of Drug Abuse (Chemical Dependency Withdrawal Treatments for Narcotic Addictions Laser Procedures Diathermy Treatment Lumbar Artificial Disc Replacement (LADR) (EJfcctive August 14, 2007) Supplies Used in the Delivery of Transcutaneous Electrical Nerve Stimulation (TENS Induced Lesions of Nerve Tracts Electrical Nerve Stimulators and Neuromuscular Electrical Stimulation (NMES) Enteral and Parenteral Nutritional Therapy Nesiritidc for Treatment of Heart Failure Patients (Effective March 2, 2006) Nebulized Beta Adrenergic Agonist Therapy for Lung Diseases- (EtTective September I 0, 2007) Screening PAP Smears and Pelvic Examinations tor Early Detection of Cervical or Vaginal Cancer Computed Tomography (CT) Magnetic Resonance Imaging (MRI) (Various Effective Dates Below) Ultrasound Diagnostic Procedures (Effective May 22, 2007) FDG Positron Emission Tomography (PET) Jor Dementia and Ncurodegcnerative Diseases (Effective September 15, 2004) Positron Emission Tomography (PET) (FDG) for Oncologic Conditions Digital Subtraction Angiography (DSA) Single Photon Emission Computed Tomograph (SPECT) Percutaneous Image-Guided Breast Biopsy Sterilization Water Purification and Softening Systems Used in Conjunction with Home Dialysis Home Use of Oxygen Pulmonary Rehabilitation Services - (Effective September 25, 2007) Treatment of Psoriasis Routine Costs in Clinical Trials (Effective July 9, 2007) Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 Cardiac Rehabilitation Programs for Chronic Heart Failure Determining Whether or Not the Beneticiary is at High Risk for Developing Colorectal Cancer Partialllospitalization Services Coverage of Intravenous Immune Globulin for Treatment of Primmy Immune Deficiency Diseases in the Home Coverage of Outpatient Rehabilitation Therapy Services (Physical Therapy, Occupational Therapy, and Speech-Language Pathology Services) Under Medical Insurance Documentation Requirements for Therapy Services Glaucoma Screening Admission Requirements Pub. 100-02 Language-Only Update for ICD-10 Limitations for Coverage Partial Hospitalization Services Coverage of Intravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the !lome Coverage of Outpatient Rehabilitation Therapy Services (Physical Therapy, Occupational Therapy, and Speech-Language Pathology Services Documentation Requirements for Therapy Services Glaucoma Screening Determining Whether or Not the Beneficiary is at High Risk for Developing Colorcctal Cancer Screening Pap Smears Admission Requirements Issued to a specific audience, not posted to Intemet/lntranet due to Sensitivity oflnstruction 68255 EN14NO14.002</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 68256 VerDate Sep<11>2014 Jkt 235001 l;:K>\~i.' ;iSc'ii 2980 PO 00000 2981 2982 Frm 00048 Fmt 4703 2985 2983 Sfmt 4725 2986 2987 E:\FR\FM\14NON1.SGM 2988 2989 14NON1 2990 2991 2992 2993 >\ti zi~f;.,;•\t)'\l.S>~x;,•, Issued to a specific audience, not posted to lnternet/lntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Internet/lntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Internct/Intranct due to Confidentiality of Instruction Issued to a specific audience, not posted to lnternetllHtranet due to Confidentiality of Instruction Beneficiary Signature Requirements for Ambulance Services Items !Ia 13 Patient and Insured Information Signature on the Request for Payment by Someone Other Than the Patient Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update FY 2015 National Coverage Determination (NCD) for Single Chamber and Dual Chamber Permanent Cardiac Pacemakers Issued to a specitic audience, not posted to lnternet/lntranet due to Confidentiality oflnstmction New Waived Tests Cardiac Rehabilitation Programs fur Chronic Hearl Failure Intensive Cardiac Rehabilitation Program Services Furnished On or After January I, 20 I 0 Cardiac Rehabilitation Program Services Furnished On or After January I, 2010 Correct Place of Service (POS) Code for CR and lCR Services on Professional Claims Requirements lor CR and !CR Services on Institutional Claims Edits for CR Services Exceeding 36 Sessions Cardiac Rehabilitation Programs, Intensive Cardiac Rehabilitation Programs, and Pulmonary Rehabilitation Programs October 2014 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files October Qumteriy Update to 2014 Annual Update ofHCPCS Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement Issued to a speci tic audience, not posted to Internet/ Intranet due to Confidentiality of Instmction Update to Pub. 100-04, Chapter 20 to Provide Language-Only Changes for Updating ICD-10 and ASC Xl2 2994 2995 2996 2997 2998 2999 3000 3001 3002 3003 3004 3005 3006 3007 3oog 3009 Partial Month Stays For Capped Rental Equipment Completion of Certificate of Medical Necessity Forms HHA Recertification for Home Oxygen Therapy Billing/Claim Formats DME MACs Only- Appeals of Duplicate Claims DME MACs- Billing Procedures Related To Advanced Beneficiary Notice (ABN) Upgrades Providing Upgrades ofDMEPOS Without Any Extra Charge Showing Whether Rented or Purchased Billing for Supplies and Drugs Related to the Effective Use ofDME Institutional Provider Reporting of Service Units tor DME and Supplies Billing for Total Parenteral Nutrition and Enteral Nutrition Furnished to Part B Inpatients Special Considerations for SNF Billing for TPN and E~ Under Part B Billing tor Splints and Casts CWF Crossover Editing for DMEPOS Claims During an Inpatient Stay DMEPOS Clinical Trials and Demonstrations Update to Pub. I 00-04, Chapter 35 to Provide Language-Only Changes for Updating ASC X 12 Issued to a specific audience, not posted to Internet/1ntranet due to Sensitivity of Instruction Remittance Advice Remark and Claims Adjustment Reason Code and Medicare Remit Easy Print and PC Print Update Update to Pub. I 00-04, Chapter 12 to Provide Language-Only Changes for Updating !CD-!0 and ASC X12 Update to Pub. I 00-04, Chapter 32 to Provide Language-Only Changes for Updating ICD-10 m1d ASC Xl2 Update to Pub. 100-04, Chapter 38 to Provide Language-Only Changes lor Updating ASC Xl2 Update to Pub. I 00-04, Chapter 09 to Provide Language-Only Changes for Updating ASC X J 2 Adjustment to Systematic Validation of Payment Group Codes for Prospective Payment Systems (PPS) Based on Patient Assessments Systematic Validation of Claims lnlormation Using Patient Assessments Issued to a specit1c audience, not posted to Internet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to lnternetllntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intcrnct/Intranet due to Sensitivity oflnstructiun Preventing Uuplicate Payments When Overlapping Inpatient and Home Health Claims Are Received Out of Sequence Issued to a specific audience, not posted to Internet/lntranct due to ConJidentiality of Instrnction Issued to a specific audience, not posted to Internet! Intranet due to Sensitivity ofinstruction Issued to a specific audience, not posted to Jnternet/lntranet due to Confidentiality of lnstmction Update to Pub. 100-04, Chapter 3 7 to Provide Language-Only Changes for Updating ASC Xl2 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 174 175 2984 EN14NO14.003</GPH> Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds- (Effective July I, 2004) Durable Medical Equipment Reference List (Effective May 5, 2005) Hospital Beds Infusion Pumps Obsolete or Unreliable Diagnostic Tests Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases Screening tor Hepatitis C Virus (HCV) in Adults Intensive Cardiac Rehabilitation Program- Benson-Hemy Institute Cardiac Wellness Program mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 3010 3012 3013 Jkt 235001 3014 PO 00000 Frm 00049 Fmt 4703 3015 3016 Sfmt 4725 3017 3018 E:\FR\FM\14NON1.SGM 3019 14NON1 3020 3021 3022 3023 3024 3025 3026 3027 3028 Coding for Outpatient Services and Physician Offices Inpatient Claim Diagnosis Reporting Update to Pub. l 00-04, Chapter l 0 to Provide Language-Only Changes for Updating ASC Xl2 Completion of Form CMS 1450 for Home Health Agency Billing Health Insurance Eligibility Query to Determine Episode Status Automation of the Request for Reopening Claims Process Application to Special Claim Types Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index, Quality Reporting Program and the Hospice Pricer for FY 2015 Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality oflnstruction October 2014 Update of the Ambulatory Surgical Center (ASC) Payment System Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality ofinstruction Update to Pub. I 00-04, Chapter 15 to Provide Language-Only Changes for Updating lCD-1 0, ASC X12, and Medicare Administrative Contractors (MAC) Implementation Medical Conditions List and Instructions General Billing Guidelines Coding Instructions lor Paper and Electronic Claim Forms Fiscal Intermediary Shared System (FISS) Guidelines B MAC (A) Bill Processing Guidelines Effective April!, 2002, as a Result of Fee Schedule Tmplementation Definitions Update to Pub. 100-04, Chapters 5 and 6 to Provide Language-Only Changes for Updating ICD-1 0, ASC Xl2, and Medicare Administrative Contractor (MAC) ImplementationOther Billing Situations Application of Financial Limitations Multiple Procedure Payment Reductions for Outpatient Rehabilitation Services Reporting of Service Units With HCPCS Coding Guidance for Certain CPT Codes- All Claims General Off-Site CORr Services Notifying Patient of Service Denial Billing for DME, Prosthetic and Orthotic Devices, and Surgical Dressings Addendum A- Chapter 5, Section 20.4- Coding Guidance for Certain CPT Codes- All Claims Consolidated Billing Requirement for SNFs Rilling SNF PPS Services Billing Procedures for Periodic Interim Payment (PIP) Method of Payment Total and 1'\oncovered Charges Services in Excess of Covered Services Reporting Accommodations on Claims Bills with Covered and Noncovered Days Billing in Benetits Exhaust and No-Payment Situations Part B Outpatient Rehabilitation and Comprehensive Outpatient Rehabilitation Facility (CORF) Services~ General Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 3011 Preventing Payment on Requests for Anticipated Payment (RAPs) When Home Health Beneficiaries are Enrolled in Medicare Advantage (MA) Plans Request for Anticipated Payment (RAP) October Quarterly Update for 2014 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule October 2014 Update of the Hospital Outpatient Prospective Payment System (OPPS) Issued to a specific audience, not posted to I nternet/Intranet due to Confidentiality of Instruction Update to Pub. I 00-04, Chapter 16 to Provide Language-Only Changes for Updating !CD-10, ASC Xl2, and Medicare Administrative Contractors (MAC) Implementation Determinations (NCDs) for Clinical Diagnostic Laboratory Services Electronic Claim Submission to A!I3 MACs (13) Hospital Billing Under Part B Hospital Laboratory Services Furnished to Nonhospital Patients Background Billing CLIA Number Submitted on Claims from Independent Labs Implementation and Updates ofNcgotiated National Coverage Paper Claim Submission to A/B MACs (B) Update to Pub. I 00-04, Medicare Claims Processing Manual, Chapter II to Provide Language-Only Changes for Updating ICD-10 and ASC X12 Two New "K" Codes for Prefabricated Single and Double Upright Knee Orthosis That Are Furnished Off-The-Shelf (OTS) Date Con·ection to Diagnosis Code Reporting on Religious Nonmedical Health Care Institution (RNHCI) Claims Required Data Elements on Claims for RNHCI Services October 2014 Integrated Outpatient Code Editor (I/OCE) Specifications Version 15.3 Medicare Claims Processing Manual, Pub. I 00-04, Chapter 4 Language Only Update for ICD-10, ASC Xl2, and Medicare Administrative Contractor (MAC) Implementation Line Item Date of Service Reporting for Partial Hospitalization General Rules for Reporting Outpatient Hospital Services Billing for Autologous Stem Cell Transplants Optional Method for Outpatient Services: Cost-Based Facility Services Plus 115 percent Fee Schedule Payment for Professional Services Billing and Payment in a Physician Scarcity Area (PSA) Identifying Primary Care Services Eligible for the PCIP Rill Review for Partial Hospitalization Services Received in Community Mental Health Centers (CMHC) Where to Report Modifiers on the Hospital Part B Claim Update to Pub. 100-04, Chapter 23 to Provide Language-Only Changes for Conversion to lCD-I 0 General Rules for Diagnosis Codes Reporting lCD Diagnosis and Procedure Codes Relationship of Diagnosis Codes and Date of Service Outpatient Claim Diagnosis Reporting ICD Procedure Code 68257 EN14NO14.004</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 68258 VerDate Sep<11>2014 3030 Jkt 235001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4725 E:\FR\FM\14NON1.SGM 14NON1 Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction Update to Pub. 100-04, Chapter 03 to Provide Language-Only Changes for Updating lCD-10 and ASC X12 Claim Formats Payment ofNonphysician Services for Inpatients Outliers Return Codes for Pricer Computer Programs Used to Support Prospective Payment System Medicare Code Editor (MCE) DRG Grouper Program Payment for Blood Clotting Factor Administered to Hemophilia Inpatients Payment tor Post Hospital SNF Care Furnished by a CAH Noncovcred Admission Followed by Covered Level of Care Outpatient Servict:s Tr<::al<::J as Inpatient Services Adjustment Bills Tolerance Guidelines for Submitting Adjustment Requests Claim Change Reasons Swing-Bed Services Providers Using All Inclusive Rates tor Inpatient Part A Charges The Standard Kidney Acquisition Charge Billing for Kidney Transplantation and Acquisition Services Heart Transplants Artificial Hearts and Related Devices Stem Cell Transplantation Allogeneic Stem Cell Transplantation Autologous Stem Cell Transplantation (AuSCT) Billing for Stem Cell Transplantation Billing for Liver Transplant and Acquisition Services Pancreas Transplants Kidney Transplants Intestinal and Multi-Visceral Transplants Billing for Abortion Services Lung Volume Reduction Surgery Nonemergency Part R Medical and Other Health Services Elections to Bill for Services Rendered Nonparticipating Hospitals Verification Process Used To Determine If the Inpatient Rehabilitation Facility Met The Classification Criteria Billing Requirements Under lRF PPS Remittance Advices Patient Classification System Processing Bills Between October 1, 2002 and the Implementation Date Billing Requirements Under LTCH PPS Billing Ancillary Services Under LTCH PPS IdentifYing Claims Eligible for the Add-On Payment for New Technology Reporting ECT Treatments Required Data Elements on Clams tor RNHCI Services Recording Determinations ofExcepted;Nonexcepted Care on Claim Records Annual Update Diagnosis Related Groups (DRGs) Adjustments 3031 3032 3033 3034 3035 3036 3037 3038 3039 3040 3041 3042 3043 3044 3045 3046 3047 Application of Code First Comorbidity Adjustments Source of Admission for lPF PPS Claims for Payment of ED Adjustment Electroconvulsive Therapy (ECT) Payment Creneral Rules Completion of the Notice of Election for RNHCI Update to Pub. I 00-04, Chapter 14 to Provide Language-Only Changes for Updating ASC X 12 ASC Procedures t(Jr Completing the ASC Xl2 837 Professional Claim Format or the Form CMS-1500 Ambulatory Surgical Center Services on ASC List List of Covered Ambulatory Surgical Center Procedures Definition of Ambulatory Surgical Center (ASC) Hospice Manual Update for Diagnosis Reporting and Filing Hospice Notice of Election (NOE) and Termination or Revocation of Election. This CR rescinds and fully replaces CR '6777. Date Required on the Institutional Claim to Medicare Contractor Completing the Uniform (Institutional Provider) Bill (Form CMS 1450) for Hospice Election Notice of Election (NOE)- Form CMS 1450 Influenza Vaccine Payment Allowances - Annual Update for 2014-2015 Season Update-Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Fiscal Year (FY) 2015 Annual Cpdate Annual Update of HCPCS Codes Used for Home Health Consolidated Billing Enforcement Issued to a speciJic audience, not posted to Internet/ Intranet due to Sensitivity of Instruction Healthcare Provider Taxonomy Codes (HPTC) Update Implement Operating Rules- Phase flf ERA EFT: CORE 360 Uniform Use of Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark Codes Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment System (PPS) Pricer Changes for FY 2015 Payment Provisions Under IRF PPS ()uality Reporting Program Common Edits and Enhancements Modules (CEM) Code Set Update Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instruction Claim Status Cate~d Claim Status Codes Update _______________ Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version 21.0, Effective January I, 2015 Instructions for Downloading the Medicare ZIP Code File for January 2015 October Update to the CY 2014 Medicare Physician Fee Schedule Database (MPFSDB) Reporting the Service Location National Provider Identifier (NPl) on AntiMarkup and Reference Laboratory Claims Payment Jurisdiction for Services Subject to the Anti-Markup Payment Limitation Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 EN14NO14.005</GPH> 3029 mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 Jkt 235001 PO 00000 3049 Frm 00051 3050 Fmt 4703 3051 Sfmt 4725 3052 E:\FR\FM\14NON1.SGM 3053 3054 3055 3056 3057 3058 Usual Facility Physicians and Supplier (Nonfacility) Billing for ESRD Services/General Billing for Durahle Medical Equipment (DME), Orthotic/Prosthetic Devices, and Supplies (including Surgical Dressings) Replacement Accessories and Supplies for External Ventricular Assist Devices or Any Ventricular Assist Device (VAD) Coding Requirements for Furnished Before May l, 2008 Coding Requirements for Furnished After May l, 2008 Ventricular Assist Devices Postcardiotomy Bridge-To -Transplantation (BTT) Destination Therapy (DT ther Artificiall-Icarts and Related Devices Annual Clotting Factor Furnishing Fcc Update 2015 Clotting Factor Furnishing Fee Sample Collection Fee Adjustment for Clinical Laboratory Fee Schedule and Laboratory Services Coding Requirements for Specimen Collection Specimen Drawing for Dialysis Patients Independent Laboratory Specimen Drawing Ambulance Inflation Factor (AI F) Intensive Cardiac Rehabilitation Program Services Furnished On or After January I, 20 l 0 Cardiac Rehabilitation Program Services Furnished On or After January I, 2010 3059 3060 3061 3062 3063 14NON1 3064 3065 3066 Correct Place of Service (POS) Code for CR and ICR Services on Professional Claims Requirements for CR and ICR Services on Institutional Claims Edits for CR Services Exceeding 36 Sessions Cardiac Rehabilitation Programs, Intensive Cardiac Rehabilitation Programs, and Pulmonary Rehabilitation Programs Int1uenza Vaccine Payment Allowances - Annual Update for 2014-2015 Season Automation of the Request for Reopening Claims Process Application to Special Claim Types New Physician Specialty Code for Interventional Cardiology Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction Common Working File (CWF) Edits Institutional Billing Requirements Professional Billing Requirements Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Codes (RARCs), Group Codes, and Medicare Summary Notice (MS~) Messages Screening for Hepatitis C Virus (HCV) October Update to the CY 2014 Medicare Physician Fee Schedule Database (MPFSDB) Billing for Cost Based Payment for Certified Registered Nurse Anesthetists (CRNA) Services Furnished by Outpatient Prospective Payment System (OPPS) Hospitals Fiscal Year (FY) 2015 Inpatient Prospective Payment System (IPPS) and Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 3048 Diagnostic Tests Subject to the Anti-Markup Payment Limitation Billing for Diagnostic Tests (Other Than Clinical Diagnostic Laboratory Tests) Subject to the Anti-Markup Payment Limitation- Claims Conditional Data Element Requirements for A/B MACs and DMEMACs Carrier Specific Requirements for Certain Specialties/Services Paper Claim Submission To Carriers/B MAC Electronic Claim Submission to Carriers!B MAC Items 14-33 - Provider of Service or Supplier Information Payment to Physician or Other Supplier for Diagnostic Tests Subject to the Anti-Markup Payment Limitation- Claims Submitted to A!B MACs New Physician Specialty Code for lnterventional Cardiology Non-Physician Specialty Codes Physician Specialtv Codes Update to Pub. 100-04, Chapter 19 to Provide Language-Only Changes for ICD-1 0, ASC Xl2, and Medicare Administrative Contractors (MAC) Implementation AlB MAC (A) - Inpatient Acute Care - Medicare Part A - Claims Processing AlB MAC (A) Payment Policy and Claims Processing Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RARCs), and Claim Adjustment Reason Codes (CARCs) Healthcare Common Procedure Coding System (HCPCS ), Applicable Diagnosis Codes, and Procedure Codes Billing Requirement for Extracorporeal Photopheresis Adjustment to Fiscal Intermediary Shared System (F!SS) Consistency Edit to Implement National Uniform Billing Committee (NUBC) Revision to Occurrence Span Code (OSC) Definition for Code 72. Two New "K" Codes for Prefabricated Single and Double Upright Knee Orthosis That Are Furnished Off-Thc-Shelf(OTS) Billing Formats Data Elements Required on Claim for Monthly Capitation Payment Billing Billing for Enteral and Parenteral Nutritional Therapy as a Prosthetic Device Mammography Screening Hospital Services Calculation of the Basic Case-Mix Adjusted Composite Rate and the ESRD Prospective Payment System Rate In-Facility Dialysis Bill Processing Procedures Required Information for In-Facility Claims Paid Under the Composite Rate and the ESRD PPS Payment for Hemodialysis Sessions Ultrafiltration Lab Services Separately Billable ESRD Drugs Physician Billing Requirements to the A/B MAC (B) Other Information Required on the Form CMS-1500 for Epoetin Alfa (EPO Other Information Required on the Form CMS-1500 for Darbepoetin Alta (Aranesp) General A/B MAC (A) Bill Processing Procedures for Method l Home Dialysis Services Physician's Services Furnished to a Dialysis Patient Away From Home or 68259 EN14NO14.006</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 68260 VerDate Sep<11>2014 3067 3069 Jkt 235001 3070 3071 3072 PO 00000 3073 Frm 00052 3074 Fmt 4703 3076 3075 Sfmt 4725 E:\FR\FM\14NON1.SGM 14NON1 EN14NO14.007</GPH> 3077 3078 3079 3080 3081 3082 3083 3084 3085 3086 Update-Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Fiscal Year (FY) 2015 Form CMS-1500 Instructions: Revised for Form Version 02/12 Items 14-33 Provider of Service or Supplier Information Items 1-11 Patient and Insured Information Items 11 a-13 Patient and Insured Information Ilealth Insurance Claim Form CMS-1500 Intensive Cardiac Rehabilitation Program -Benson-Henry Institute Cardiac Wellness Update to Pub. I 00-04, Chapter 17 to Provide Language-Only Changes for Updating ICD-10 and ASC Xl217/100/ The Competitive Acquisition Program (CAP) for Drugs and Biologicals Not Paid on a Cost or Prospective Payment Basis Submitting the Prescription Order Numbers and No Pay Modifiers Hospital Billing For Take-Home Drugs Hospital Outpatient Payment Under OPl'S for New, Unclassilled Drugs and Biologicals After FDA Approval But Before Assignment of a ProductSpecific Drug or Biological HCPCS Code Claims Processing Rules for F.SAs Administered to Cancer Patients for AntiAnemia Therapy Intravenous Immune Globulin MS'J/Remillance Messages for Immunosuppressive Drugs Requirements for Billing A/B MAC (A) for Immunosuppressive Drugs Billing and Payment Instructions for A/B MACs (A) MSN Denial/Claim Adjustment and Remark Messages for Anti-Emetic Drugs HCPCD Codes for Oral Anti-Emetic Drugs MSN/Ciaim Adjustment Message Codes for Oral Cancer Drug Denials Claims Processing Requirements -General Billing Drugs Electronically- NCPDP Foreword Formats for Submitting Claims to Electronic Submission Requirements liiPAA Standards for Claims Paper Claims Where to Purchase HIPAA Standard Implementation Guides Paper Formats for Institutional Claims Paper Formats for Professional and Supplier Claims Remittance Advices Payment Jurisdiction Among Local A/B MACs for Services Paid Under the Physician Fee Schedule and Anesthesia Services Claims Processing Instructions for Payment Jurisdiction Payment to Physician or Other Supplier for Diagnostic Tests Subject to the Anti- Markup Payment Limitation/ Claims Submitted to AlB MACs (B) Billing Procedures for Entities Qualified to Receive Payment on Basis of Reassignment/ lor A/B MACs(B) Processed Claims Billing for Diagnostic Tests (Other Than Clinical Diagnostic Laboratory Tests) Subject to the Anti-Markup Payment Limitation/ Claims Submitted to AB/MACs(B) Billing Form as Request for Payment Beneficiary Request for Payment on Provider Record- Institutional Claims Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 3068 Long Term Care Hospital (L TCH) PPS Changes Issued to a specitic audience, not posted to Internet/ Intranet due to Confidentiality of Instruction Quarterly l Jpdate tor the Durable Medical Equipment, Prosthetics. Orthotics Supplies (DMEPOS) Competitive Bidding Program (CBP)- January 2015 Issued to a specific audience, not posted to Internet/ Intranet due to Conlidenlialily ofTnslruction New Waived Tests Manual Update to Clarify Claims Processing tor Laboratory Services Travel Allowance Independent Laboratory Specimen Drawing Jurisdiction of Laboratory Claims January 2015 Quarterly Average Sales Price (ASP) Medicare Pan B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files New Physician Specialty Code for lnterventional Cardiology Non-Physician Specialty Codes Physician Specialty Codes Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction Date Correction to Diagnosis Code Reporting on Religious Nonmedical Health Care Institution (RNHCI) Claims Update to Pub. 100-04, Chapter 15 to Provide Language-Only Changes for Updating lCD-I 0, ASC X 12, and Medicare Administrative Contractors (MAC) Implementation Medical Conditions List and Instructions Definitions Coding Instructions tor Paper and Electronic Claim Forms Fiscal Intermediary Shared System (FISS) Guidelines A/B MAC (A) Bill Processing Guidelines Effective April L 2002, as a Result of Fee Schedule Implementation General Billing Guidelines Maintenance and Update of the Temporary Hook Created to Hold OPPS Claims that Include Certain Drug HCPCS Codes October 2014 Update of the Ambulatory Surgical Center (ASC) Payment System Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction October 2014 Update of the Hospital Outpatient Prospective Payment System (OPPS) Update to Pub. 100-04, Chapter 23 to Provide Language-Only Changes for Conversion to ICD-10 Reporting !CD Diagnosis and Procedure Codes Relationship of Diagnosis Codes and Date of Service Inpatient Claim Diagnosis Reporting Outpatient Claim Diagnosis Reporting lCD Procedure Code Coding for Outpatient Services and Physician Offices General Rules for Diagnosis Codes mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 Jkt 235001 PO 00000 Frm 00053 3088 Fmt 4703 3089 3090 3091 Sfmt 4725 E:\FR\FM\14NON1.SGM 14NON1 3092 3093 3094 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction 3095 ';v,•,'.;;;,,\\1, ~;Fl:{; 101 102 103 104 105 106 .0:\!t,J·~•:t.~ .... 237 238 239 240 241 242 243 ''" ··Iii 0 '·•\ \\\It~ i)~i •~\ /1, ~I..i\i~;i ;.s~IJ'\) Additional Electronic Correspondence Referral System (ECRS) Reason Codes Electronic Correspondence Referral System (ECRS) Electronic Correspondence Referral System (ECRS) Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Internet/ Intranet due to Conlidentiality of Instruction Electronic Correspondence Referral System (ECRS) notification regarding Defense of Marriage Act (DOMA) and ICD-10 changes Medicare Secondary Payer (MSP) Group Health Plan (GHP) Working Aged Policy-- Definition of"Spouse"; Same-Sex Mnrr;""''~ ;. ;~~:~ '<' · Notice of :--Jew Interest Rate tor Medicare Overpayments and Underpayments - 4th Qtr. Notification for FY 2014 New Physician Specialty Code for Interventional Cardiology Exhibit Pari D(l )/Claims Processing Timeliness- All Claims Classification of Claims for Counting Physician/Limited License Physician Specialty Codes Non-Physician Practitioner/Supplier Specialty Codes Part E/Interest Payment Data Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instmction Transitioning Medicare Administrative Contractor (MAC) Workloads to the New Banking Contractor(s) Recovery Auuil Program Tnu;king Appeab and Reopenings Tracking Appeals and Reopeuings Medicare Financial Management Manual, Chapter 7, Internal Controls List of CMS Contractor Control Objectives OMR Circular A-123, Appendix A: Internal Controls Over Financial Reporting (ICOFR) Ceriilication Statement CPIC- Report of Internal Control Deficiencies Statement on Standards for Allestation Engagements (SSAE) Number 16, Reporting on Controls at Service Providers Submission, Review, and Approval of Corrective Action Plans Corrective Action Plan (CAP) Reports CMS Finding Numbers Quarterly CAP Report Certification Package for Internal Controls (CPIC) Requirements Notice of New Interest Rate for Medicare Overpayments and Underpayments - 1st Qtr Notification for FY 2015 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 3087 ASC X12 837 Institutional Claim Format Definition of a Claim for Payment Policy and Billing Instructions for Condition Code 44 General Information on Non-covered Charges on Institutional Claims Determining Start Date of Timely Filing Period-- Date of Service Form Prescribed by CMS Accordance with CMS Instructions Handling Incomplete or Invalid Submissions Claims Forms Cv!S 1490S and CMS-1450 Data Element Requirements Matrix Payer Only Codes Utilized by Medicare B MAC(B) Specific Requirements tor Certain Specialties/ Services Consistency Fdits for Institutional Claims Inpatient Part A Hospital Adjustment Bills Conditional Data Element Requirements for A/B MACs (B) and DME MACs 2015 Annual Update for the Health Professional Shortage Area (HPSA) Bonus Payments 2015 Annual Update ofHealthcare Common Procedure Coding System (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Update Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction Ambulance Inflation Factor for CY 2015 and Productivity Adjustment Update to Pub. 100-04 Chapter 13 to Provide Language-Only Changes tor Updating ICD-10 and ASC Xl2 !CD Coding for Diagnostic Tests A/B MAC (A)Payment tor Low Osmolar Contrast Material (LOCM) (Radiology) Special Billing Instructions for RHCs and FQHCs Payment Requirements Medicare Summary Notices (MSN ), Reason Codes, and Remark Codes Billing Instructions Coverage for PET Scans for Dementia and Neurodegenerative Diseases Place of Service (POS) Instructions for the Professional Component (PC or Interpretation) and the Technical Component (TC) of Diagnostic Tests Billing and Coverage Changes for PET Scans Billing and Coverage Changes for PET Scans for Cervical Cancer Effective for Services on or After November I 0, 2009 Billing and Coverage Changes tor PET (1\aF-18) Scans to IdentitY Bone Metastasis of Cancer Effective for Claims With Dates of Services on or After February 26, 20 I 0 EMC Formats Payment Methodology and HCPCS Coding Billing Requirements for C:MS Approved Clinical Trials and Coverage With Evidence Development Claims for PET Scans for Neurodegeneralive Diseases, Previously Specified Cancer lndicatiom, and All Other Cancer Indications Not Previously Specified Annual Medicare Physician Fee Schedule (MPFS) Files Delivery and Implementation Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instruction 68261 EN14NO14.008</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 68262 VerDate Sep<11>2014 r;,~;;' \? 119 Jkt 235001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4725 E:\FR\FM\14NON1.SGM 14NON1 EN14NO14.009</GPH> 121 122 123 1':.\;nrt"~l ,;;':.:~'"'~.~ Rehabilitation Agencies -Fire Alarm Systems Standard: Disaster Plan Standard: Safety of Patients Revisions to State Operations Manual (SOM) Chapter 5 Maximum Time Frames Related to the Federal Onsite Investigation of Complaints/Incidents Priority Definitions for Nursing Homes, Deemed and Non-Deemed NonLong Term Care Providers/Suppliers, and EMTALA Immediate Jeopardy (for Nursing Homes, Deemed and Non-Deemed NonLong Term Care Providers/Suppliers, and EMTALA) Non-Immediate Jeopardy- High Priority (tor Nursing Homes and Deemed and Non-Deemed Non-Long Term Care Providers/Suppliers) Non-Immediate Jeopardy- Medium Priority (tor Nursing Homes and Deemed and Nun-Deemed Non-Long Term Care Provid<.:rs/Supplicrs) Non-Immediate Jeopardy- Low Priority (for Nursing Homes and Deemed and Non-Deemed Non-Long Term Care Providers/Suppliers) Administrative Review/Offsite Investigation (for Nursing Homes and Deemed and Non-Deemed Non-Long Term Care Providers/Suppliers) Referral Immediate (for Nursing Homes, Deemed and Non-Deemed NonLong Term Care Providers/Suppliers, and EMTALA) Referral- Other (for Nursing Homes, Deemed and Non-Deemed Non-Long Term Care Providers/Suppliers, and EMTALA) No Action Necessary (for Nursing Homes, Deemed and Non-Deemed NonLong Term Care Providers/Suppliers, and EMTALA) Priority Assignment for Nursing Homes, Deemed and Non-Deemed Non1,ong Term Care Providers/Suppliers, and EMT AI ,A Update to State Operations Manual (SOM), Publication 100-07, Chapter 3, to Provide Language-Only Changes for Updating ICD-10 Specific Criteria for Psychiatric Units/31 06B 1 - Patient Criteria Revisions to State Operations Manual (SOM), Appendix A Survey Protocol, Regulations and Interpretive Guidelines for Hospitals Medicaid Provisions Clinical Laboratory Improvement Amendments (CLIA Look-Behind Authority Certification Related Functions of SA Accredited CLIA Laboratories CMS and AO Information Exchange Regarding Deemed Providers/Suppliers (Excluding CLlA) AO Reporting Requirements RO Requirements for Review of AO Reporting RO Reporting Requirements to AOs Assisting Applicant Providers and Suppliers Initial Certification "Kits Deemed Status Providers Suppliers, Exduding CLIA Provider-Based Determinations Medicare Health Care Provider Supplier Enrollment Approval or Denial Enrollment Denial Based on MAC Review Approval or Denial of Certification Based on Survey Findings Reconsideration of Denial Deemed Providers/Suppliers, Excluding CLlA Deemed Providers/Suppliers Except CLlA-Additional Information Surveys of New Providers and Suppliers Effective Date of Medicare Provider Agreement or Approval for Suppliers Reasonable Assurance Surveys Effective Date of Provider Agreement After Reasonable Assurance Non-deemed Hospitals Recertification ofNon-deemed Hospitals Deemed Status: Hospitals Accredited by an Accrediting Organization with a CMS-approved Medicare Hospital or Medicare Psychiatric Hospital Accreditation Program Notice that a Participating Hospital Has Been Accredited and Recommended for Deemed Status Recertification Medicaid Provisions Clinkal Laboratory Improvement Amendments (CLIA Look-Behind Authority Certification Related Functions of SA Accredited CLlA Laboratories CMS and AO Information Exchange Regarding Deemed Providers/Suppliers (Excluding CLIA) AO Reporting Requirements RO Requirements for Review of AO Reporting RO Reporting Requirements to AOs Assisting Applicant Providers and Suppliers Initial Certification "Kits Deemed Status Providers Suppliers. Excluding CLIA Provider-Based Determinations Medicare Health Care Provider Supplier Enrollment Approval or Denial Enrollment Denial Based on MAC Review Approval or Denial of Certification Based on Survey Findings Reconsideration of Denial Deemed Providers/Suppliers, Excluding CUA Deemed Providers/Suppliers Except CLIA-Additional Information Surveys ofl\ew Providers and Suppliers Effective Date of Medicare Provider Agreement or Approval for Suppliers Reasonable Assurance Surveys Effective Date of Provider Agreement After Reasonable Assurance Non-deemed Hospitals Recertification of Non-deemed Hospitals Deemed Status: Hospitals Accredited by an Accrediting Organization with a CMS-approved Medicare Hospital or Medicare Psychiatric Hospital Accreditation Program Notice that a Participating Hospital Has Been Accredited and Recommended tor Deemed Status Recertification Notification of Withdrawal or Loss of Accreditation Psychiatric Ho~tals and Deemed Status Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 120 ;;.c~,.·.)c; mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 Jkt 235001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4725 E:\FR\FM\14NON1.SGM 14NON1 Representative Sample Validation Surveys of Deemed Providers Suppliers Substantial Allegation Validation Surveys of Deemed Providers Suppliers SA Preparation for Validation Survey Provider Supplier Authorization for Validation Survey Provider Supplier Refusal to Permit Validation Survey Forwarding Validation Survey Records to RO Actions Following Validation Survey Providers Suppliers Found in Compliance Following Validation Survey 3/3254B-Providcrs Suppliers Found Not in Compliance with One or More Conditions Following Validation Survey and \loncompliance Constitutes Immediate Jeopardy Condition-level Deficiencies That Do Not Pose Immediate Jeopardy Plans of Correction Termination or Other Adverse Accreditation Action for a Deemed Provider or Supplier Reinstatement to Accrediting Accreditation Organization Jurisdiction RO Provision oflnformation to Accrediting Organizations Psychiatric Hospitals and Deemed Status Medicaid-Only Hospitals Initial Certification of Medicaid-Only Hospitals Certification Surveys of Medicaid-Only Hospitals Change in Certification Termination Complaint Investigation Determining Compliance with OASIS Transmission Requirements HHAs Seeking Initial Certification Participation through Deemed Status Exceptions to Demonstrating Compliance with OASIS Submission Requirements Prior to Approval Compliance Dates and PPS Instructions for Handling Medicare Patients in HHAs Seeking Initial Certification Instructions to New HHAs Concerning all Other Patients Survey Team Workload Completion Instructions for Certification and Transmittal, Form CMS-1539 RO Completion Instructions for Certification and Transmittal, Fmm CMS1539, Items 19- 32 Medicaid-Only Certification Change in Certification Medicaid NF and Medicaid Distinct Part NF Providers Seeking to Participate as Medicare SNF Provider Medicare- and \lledicaid-Participating Hospitals Seeking to Become Medicaid-Only Hospital 2/2777D3-Medicaid-Only Hospitals Seeking to Participate in Medicare and Medicaid 2/2778-0bjectives of RO Certification Review CMS Certification Numbers for Medicaid Providers Effective Dale of Provider Agreement, Fonn CMS-1561, and Supplier Approval Compliance with All Federal Requirements All Health and Safety Standards Are Not Met on the Day of the Survey Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 Medicaid-Only Hospitals Initial Certification of Medicaid-Only Hospitals Certification Surveys of Medicaid-Only Hospitals Change in Certification Termination Complaint Investigation Determining Compliance with OASIS Transmission Requirements HHAs Seeking Initial Certification Participation through Deemed Status Exceptions to Demonstrating Compliance with OASIS Submission Requirements Prior to Approval Compliance Dates and PPS Instructions for Handling Medicare Patients in HHAs Seeking Initial Certification Instructions to New HHAs Concerning all Other Patients Survey Team Workload Completion Instructions for Certification and Transmittal, Fom1 CMS-1539 RO Completion Instructions for Certification and Transmittal, Form CMS1539, Items 19-32 Medicaid-Only Certification Change in Certification Medicaid NF and Medicaid Distinct Part NF Providers Seeking to Participate as Medicare SNF Provider Medicare- and :vtedicaid-Participating Hospitals Seeking to Become Medicaid-Only Hospital 2/2777D3-Medicaid-Only Hospitals Seeking to Participate in Medicare and Medicaid 2/2778-0bjectives of RO Certification Review CMS Certification Numbers for Medicaid Providers EtTective Date ofProvider Agreement, Form CMS-1561, and Supplier Approval Compliance with All Federal Requirements All Health and Safety Standards Are Not Met on the Day of the Survey CMS Authority to Terminate Medicare and Medicaid Participation Termination of Title XIX-Only NFs, ICFslliD, Hospitals and Psychiatric Hospitals Termination Action Based Upon Onsite Survey by RO, or Validation Survey of a Deemed Provider or Supplier by RO or SA Services for which Federal Financial Participation (FFP) May Be Temporarily Continued After Termination of a Medicaid Provider or Nonrenewal or Cancellation of an ICFIIID Provider Agreement Processing of Immediate Jeopardy Terminations fermination Procedures Substantial Noncompliance; No Immediate Jeopardy (Medicare) Termination of Psychiatric Hospitals Termination Action Based on Onsite Survey of Medicare Provider or Supplier (Excluding SNFs) Conducted by RO Stall Plan ofCotTection (PoC) General Information on IPPS Exclusion Deemed Providers and Suppliers Validation Surveys - General Objective ofValidation Surveys 68263 EN14NO14.010</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 68264 VerDate Sep<11>2014 534 535 536 537 Jkt 235001 538 539 PO 00000 540 Frm 00056 541 542 543 Fmt 4703 Sfmt 4725 544 545 E:\FR\FM\14NON1.SGM :v'l )}\\ None )?;§f;~[~,'l ,,~' :;;s;1,::;~.s\~~;si!:•; Update to Pub. I 00-10, Chapters 04 and 07 to Provide Language-Only Cl1angcs for Updating ICD-10 18 , t'IIII~1Jj;,;;•~(•i'i~ '.lc::£·•· None 14NON1 526 527 528 529 530 531 I 532 EN14NO14.011</GPH> Documentation for Durable Medical Equipment Prosthetics, Orthotics and Supplies (DMEPOS) Repair Claims Claims that are related Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality of Instruction Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality of Instruction Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality ofinstruction Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality of lnstmction Cardiac Rehabilitation Programs for Chronic Heart Failure Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR) Claims that are related Requesting Additional Documentation During Prepayment and Postpayment Review Claims that arc related Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality of lnstrnction Defending Medical Review Decisions at Administrative Law Judge (ALJ) Hearings The ALJ Hearing Collaboration Participation in the ALI Hearing Party in the ALJ Hearing Defending Medical Review Decisions at Administrative Law Judge (ALJ) Hearings 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 Confid.,nti~lity of Instmction 533 Issued to a specific audience not posted to Internet/ Intranet due to Conlidcntiality of Instruction Provider Notice on MAC Web Sites Proof of Delivery--Supplier Documentation Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality of lnstrnction Cardiac Rehabilitation Programs for Chronic Heart Failure Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR) Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality oflnstruction Incorporation of Various Form CMS-855 Processing Activities into Pub. I 0008, Program Integrity Manual (PIM), Chapter 15 ·'' •·•·•····;' None .••.. ··"·~"'·'if{.'i; .~~ None \ .•.. .•;•••'·~~~·' ·\~\·.·~·~·:•\;~:\!5 .• IMt::•'li"''l'•' \\;\is\;i.J;~;·,~i~\ ;;;'l\if~.· None !}:/•~•· ?;i~ 'i~s.:,r;,((~·~;,~;~., 1~1 0~;••;i;~··~·~·~(".';·•! i'i (P•;~.:'~h"'~:. Nunc ~ii,••l'.i~$,•1\ ;. ;.:· . . . ·. t•:••:;~·;: ····~ :2:;\~~0t•·;··{~·~iis:z'••i Implementation of a Prospective Payment System (PPS) for Federally 1395 Qualified Health Centers (FQIICs) 1396 Clarification of Remittance Advice Code Combination Reports Generated by • . ·••·· · · Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 CMS Authority to Terminate Medicare and Medicaid Participation rermination of Title XIX-Only NFs, lCFs!IID, Hospitals and Psychiatric Hospitals Termination Action Based Upon Onsite Survey by RO, or Validation Survey of a Deemed Provider or Supplier by RO or SA Services for which Federal Financial Participation (FFP) May Be Temporarily Continued After Termination of a Medicaid Provider or Nonrenewal or Cancellation of an ICF/IID Provider Agreement Processing of Immediate Jeopardy Terminations Termination Procedures- Substantial Noncompliance; No Immediate Jeopardy (Medicare) Termination of Psychiatric Hospitals Termination Action Based on Onsite Survey of Medicare Provider or Supplier (Excluding SNfs) Conducted by RO Staff Plan of Correction (PoC) Generallntormation on IPPS Exclusion Deemed Providers and Suppliers Validation Surveys- General Objective of Validation Surveys Representative Sample Validation Surveys of Deemed Providers Suppliers Substantial Allegation Validation Surveys of Deemed Providers Suppliers SA Preparation for Validation Survey Provider Supplier Authorization for Validation Survey Provider Supplier Refusal to Permit Validation Survey Forwarding Validation Survey Records to RO Actions Following Validation Survey Providers Suppliers Found in Compliance following Validation Survey 3!3254B-Providcrs Suppliers Found Not in Compliance with One or More Conditions Following Validation Survey and \loncompliance Constitutes Immediate Jeopardy Condition-level Deficiencies That Do Not Pose Immediate Jeopardy Plans of Conection Termination or Other Adverse Accreditation Action for a Deemed Provider or Supplier Reinstatement to Accrediting Accreditation Organization Jurisdiction RO Provision oflnformation to Accrediting Organizations mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 1399 1400 Jkt 235001 1402 PO 00000 1401 1404 1403 Frm 00057 1405 1406 Fmt 4703 1407 Sfmt 4725 1408 E:\FR\FM\14NON1.SGM 1410 1409 1411 1412 ___ ~i41_3 1414 14NON1 1415 1416 1417 1418 1419 1420 Shared Systems Consolidation of HIULAS Organizations tor a MAC- Organization Merges Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality of Instructions Federally Qualified Health Centers Prospective Payment System- Recurring File Updates Issued to a specific audience not posted to Internet/ Intranet due to Sensitivity of Instructions Fee for Service Beneficiary Data Streamlining (FFS BDS)- Phase IIAuxiliary Data Issued to a specific audience not posted to Intemet/ Intranet due to Sensitivity oflnstructions Change in Applying Co-insurance and Lifetime Reserve (L TR) Amounts on Informational Only Claims with Condition Code (CC) 04 Modify the Daily Common Working File (CWF) to Medicare Beneticiary Database (MBD) File to no longer include Preventive Healthcarc Common Procedure Coding System (HCPCS) Codes that have been terminated. Diagnosis Reporting on Home Health Claims Coding System (HCPCS) Codes that have been terminated. Add Smoking Cessation Initial Session Date to the Common Working File (CWF) to Medicare Beneticimy Database (MBD) Extract File. Inpatient Hospital Claims and Medicare Secondary Payer (MSP) Claims with Medicare Coinsurance Days and/or Medicare Lifetime Reserve Days Occurring in the Seventh or More Calendar Years- Analysis and Design Only Fee for Service Beneficiary Data Streamlining (FFS BDS) Updates to Operational Issues !DR Shared Systems Daily Claims Feeds Expansion to Accommodate Ambulance Data Elements Instructions for Removing Logic Involving the IUR Implemented with CR8271 Removal of User-Controlled Effective Dale lu Apply Therapy Caps to Critical Access Hospital (CAH) Claims Modifying FISS Part B Claims Overlap Edit~ela~ to CJIIIS-1592::!'_ _ _ _ Medicare Remit Easy Print (MREP) Enhancement Health Insurance Portability and Accountability Act (HIPAA) EDT Front End Updates for January 2015 Issued to a specific audience not posted to Internet/ Intranet due to Sensitivity of Instructions Issued to a specitic audience not posted to Internet/ Intranet due to Sensitivity oflnstructions Issued to a specific audience not posted to Internet/ Intranet due to Sensitivity of Instructions Implement Operating Rules- Phase III ERA EFT: CORE 360 Uniform Use of Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark Codes (RARC) Rule- Update ftom CAQH CORE- July 1, 2014 version 3.1.1 Clarification of Remittance Advice Code Combination Reports Generated by Shared Systems DMEPOS Competitive Bidding Program (CBP): Correction to VMS 1421 1422 1421 1424 1425 1426 1427 l42X 1429 ~)~~!\\~~~~~ 25 26 27 28 29 30 31 32 33 34 Processing of Wheelchair Accessory Claims for Round 2 Revised Modification to the Medically Lnlikely Edit (MUE) Program Specific Modifiers for Distinct Procedural Services lntemational Classification of Diseases, I Oth Revision (lCD-I 0) TestingAcknowledgement Testing with Providers !DR Shared Systems Daily Claims Feeds Expansion to Accommodate Medical Review Data Element Issued to a specific audience, not posted to Internet/lntranet due to a Sensitivity of Instruction Issued to a specific audience, not posted to lnternet/lntranet due to a Sensitivity of lnstmction Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity oflnstruction Correction to Hospice Notice of Kevocation Processing Fee for Service Beneficiary Data Streamlining (FFS BDS) Updates to Operational Issues ).~'·~·<;,;),;~\~ Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality of Instructions Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality of Instructions Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality oflnstructions Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality of Instructions Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality of Instructions Issued to a specific audience not posted to Internet/ Intranet due to Confidentiality oflnstructions Language-Only Changes for Updating ICD-1 0 and ASC X12 Language in Pub 100-22, Chapters 1 and 2 Coding and Reporting Principles for Claims-Based Reporting Issued to a speci fie audience not posted to Internet/ Intranet due to Confidentiality of Instructions Issued to a specific audience not posted to Internet/ Intranet due to ConJidentiality oflnstructions Addendum II: Regulation Documents Published in the Federal Register (July through September 2014) Regulations and Notices Regulations and notices are published in the daily Federal Register. To purchase individual copies or subscribe to the Federal When ordering individual Register, contact GPO at copies, it is necessary to cite either the date of publication or the volume number and page number. Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 1397 1398 68265 EN14NO14.012</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 68266 VerDate Sep<11>2014 ~~~~~~~~ ~ Jkt 235001 following website provides infonnation on how to access electronic editions, printed editions, and reference copies. This information is available on our website at: PO 00000 For questions or additional infonnation, contact Terri Plumb (410-786-4481 ). Frm 00058 Fmt 4703 Sfmt 4725 Addendum III: CMS Rulings CMS Rulings are 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 unp.11 vv wvv .L"'"·!:b"v' ''""'!:bmauu""For questions or additional infom1ation, contact Tiffany Lafferty (41 0-786-7548). E:\FR\FM\14NON1.SGM 14NON1 Addendum IV: Medicare National Coverage Determinations (July through September 2014) 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 title, the date the publication was issued, and the effective date ofthe decision. An NCD is a detennination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVlll of the Act), but does not include a detennination 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. Infom1ation on completed decisions as well as pending decisions has also been posted on the CMS website. For the purposes of this quarterly notice, we list only the specific updates that have occurred in the 3-month period. This information is available at: 2::..!~~~~~"-~~~~~~-~~~ For questions or additional information, contact Wanda Belle (410-786-7491 ). Title NCDM Section Issue Date Effective Date NCD 20.10 Rl71 07/18/2014 02/18/2014 NCD20.9 RI72 08/29/2014 10/30/201 NCD210.13 Cardiac Rehabilitation Programs -Chronic Heart Failure Bridge-toti Destination Transmittal Number R174 09/05/2014 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 EN14NO14.013</GPH> 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 06/02/2014 Ua..-..'""-t-;t-;.,r Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (July through September 2014) 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 the 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 April 21, 1997 Federal Register (62 FR 19328). IDE G140004 Gl40016 Device INFUSE Bone Graft Veniti Vici Venous Stet System l2mm x 60mm x IOOcm, 12mm x 90mm x IOOcm, 12mm x 120mm x !OOcm, 14mm x 60mm x I OOcm, 14mm x 60mm x 1OOcm, 14mm x 120mm x 1OOcm, 16mm x 60mm x I OOcm, 16mm x 90mm x 1OOcm, 16mm x 120mm x I OOcm Start Date 07/02/2014 07/02/2014 i mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 Gl40110 Gl40111 Jkt 235001 Gl40113 PO 00000 Gl40114 G140116 G140117 Frm 00059 0140090 Gl40123 Gl40079 0140124 Fmt 4703 Gl40132 Gl40131 Sfmt 4725 Gl40103 E:\FR\FM\14NON1.SGM 0140135 Gl40138 Gl40145 0140139 0140140 Gl40141 14NON1 (1140136 Gl40037 Gl30154 0130282 0140149 G140152 0140098 Gl40153 Gl40155 G140157 Gl40159 DLBCL IHC Classification PARHMDX Assay TEOSYAL RHA Ultradeep (TPUL) Repair of Complex Abdominal Aortic Aneurysms Using Custom Made Device (CMD) Ancora LLC lnterbody Fusion Device TransMedics Organ Care System-Heart; TransMedics Organ Care System Heart Console; TransMedics OCS Heart Perfusion Set; TransMcdics OCS Hcan Perfusion Module; TransMedics OCS Heart Solution Set THORATEC HEARTMATE lil LEFT VENTRICULAR ASSIST SYSTEM (L VAS) VLcAblate System Apollo Onyx Delivery Micro Catheter Protocol2013-0232: Pilot Study ofRobotic-Assisted Harvest Of The Latissimus Dorsi Muscles Lotus Valve System miraDry Svstem Therakos Cellex Photopheresis System Abbott Sensor Based Glucose Monitoring System -Personal and Pro Low Dose External Beam Irradiation Heterotopic lmplantatin of The Edwards-Sapien XT Transcatheter Valve in The Interim Vena Cava For 'T'he Treatment of Severe Tricuspid Regurgitation (Hover) Trial Boston Scientific Precision Plus Spinal Cord Stimulator System with Artisan Epidural Array NovoTTF-IOOA System LiteStream Balloon Expandable Vascular Covered Stent Barostim NEO Implantable Pulse Generator (lPG) Model 2 I 02, Barostim NEO Carotid Sinus Lead (CSL) Model1036 and 1037, Programmer System Model90!0 Dako PD-L I 22C3 pharmDx kit Spincology Intcrbody Fusion System (SIFS) Turbo-Elite RX Laser Athcrcctomy Catheters 410-154,4140159, 417-156, 420-159; Turbo-Elite OJW Laser A1therectomy Catheters 410-1 SO, 414-152, 420-006, 423-001, 425-011 The Mitral Trial Extremity Exsanguination Device (EED) Exalherm-TBH Samfilcon A Soft (hydrophilic) Contact Lens Bipolar-VI: Bipolar Catheter Ablation Novilase System Tablo Hemodialvsis Svstem High-Resolution MicroenJoseopy (HRME) in patienb with adenocarcinoma in-situ (AIS) of the cervix EPI Procolon Glucoclear System St Jude Medical ~1ultiprogra111 Sti111u1ator (NITS) Syste111 07/03/2014 07/09/2014 07/16/2014 07/14/2014 07/23/2014 07/24/2014 07/25/2014 07/25/2014 07/31/2014 08/01/2014 08/07/2014 08/07/2014 08/08/2014 08/15/2014 08/20/2014 08/22/2014 08/22/2014 08/27/2014 08/28/2014 08/28/2014 08/28/2014 08/28/2014 Addendum VI: Approval Numbers for Collections of Information (July through September 2014) All approval numbers are available to the public at Reginbgov. Under the review process, approved information collection requests are assigned OMB control numbers. A single control number may apply to several related information collections. This information is available at For questions or additional information, contact Mitch Bryman (410-786-5258). Addendum VII: Medicare-Approved Carotid Stent Facilities, (July through September 2014) Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing 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: For questions or additional information, contact Lori Ashby ( 410-nl6-6322 ). Provider Number 09/04/2014 09/05/2014 09/05/2014 09/05/2014 09/08/2014 09/10/2014 09/11/2014 09/12/2014 09/17/2014 09/19/2014 09/19/2014 1265877567 4507[8 1871935072 290 I Swann Avenue Tampa FL 33609-4057 FROM: University Hospital TO: UC Medical Center 234 Goodman Street Cincinnati, OH 45219-2364 360003 10/11/2005 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 Gl40121 Gl40106 0140108 I OH 68267 EN14NO14.014</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 68268 VerDate Sep<11>2014 Provider Number Effective Date State FROM: St. John's Regional Medical Center TO: Mercy Hospital Joplin 2817 St. John's Boulevard Joplin, MO 64804 260001 04/19/2005 MO American College of Cardiology's National Cardiovascular Data Registry at: For questions or additional information, contact Marie Casey, BSN, MPH (410-786-7861 ). City Jkt 235001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 E:\FR\FM\14NON1.SGM Addendum Vlll: American College of Cardiology's National Cardiovascular Data Registry Sites (July through September 2014) 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 ofthe 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) lCD Registry satisfies the data reporting requirements in the NCO. Hospitals needed to transition to the ACC-NCDR lCD 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 are available in the Medicare NCD Manual, which is on the CMS website at 14NON1 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 ~Y~Jl£ill::'QQJ.n0:Y£lm£ill!:£QJ:illllQ!l For the purposes of this quarterly notice, we arc providing only the specific updates that have occurred in the 3-month period. This information is available by accessing our website and clicking on the link for the Baptist Health Medical Center Centinela Ho~tal Medical Center Providence Saint John's Health Center Interfaith Medical Center Putnam Community Medical Center Kearney Regional Medical Center Oak Bend Medical Center West Valley Medical Center Texas Regional Medical Center at Sunnyvale Banner Ogallala Community Hospital Pinnacle Health System: West Shore Hospital Emanuel Medical Center Huntsville Memorial Ho~tal Kaiser Foundation Hospital-Santa Rosa Weirton Medical Center Scott & White HealthCare-Round Rock North Little Rock Inglewood Santa Monica Brooklyn Palatka Kearney Richmond Caldwell Sunnyvale Ogallala Harrisburg Turlock Huntsville Santa Rosa Weilion Round Rock Stale I AR CA CA NY FL NE I I I I TX lD TX NE PA CA TX CA wv TX E~i~~f~:~~~~f~~~~~dical Ct:~~-!:1:~------- I ~e~~~Jl!l~-------t-~~---Connecticut Children's Medical Center SSM Cardinal Glennon Children's Medical Campbell County Memorial Scott & White Hospital - College Station Guadalupe Regional Medical Center I Hartford St. Louis Gillette College Station Seguin I CT MO WY TX TX Addendum IX: Active CMS Coverage-Related Guidance Documents (July through September 2014) There were no CMS coverage-related guidance documents published in the July through September 2014 quarter. To obtain the document, visit the CMS coverage website at For questions or additional information, contact JoAnna Baldwin (41 0-786-7205). Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (July through September 2014) There were no special one-time notices regarding national coverage provisions published in the July through September 2014 quarter. Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices 17:37 Nov 13, 2014 EN14NO14.015</GPH> Facility mstockstill on DSK4VPTVN1PROD with NOTICES For questions or additional infommtion, contact Marie Casey, BSN, MPH (410-786-7861). Sfmt 4725 For questions or additional information, contact Stuart Caplan, RN, MAS (41 0-786-8564). Jkt 235001 PO 00000 Frm 00061 E:\FR\FM\14NON1.SGM 14NON1 Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (July through September 2014) 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 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 VA Ds used as destination therapy are reasonable and necessary only if performed in facilities that have been detennined 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 VADs implanted as destination therapy. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred to the list of Medicare-approved Provider Number Memorial Regional Hospital I I 0-0038 3501 Johnson Street Hollywood, FL 33021 I 50-0030 PeaceHealth Medical Center 101 West 8th Avenue Sookane, WA 99220 9117/2014 WA Addendum XIII: Lung Volume Reduction Surgery (L VRS) (July through September 2014) Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage tor 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 (LVRS): • 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 ofHealthcare Organizations (JCAHO)) under their Disease Specific Certification Program for LVRS; 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 July through September 2014 quarter. This information is available at For questions or additional information, contact Marie Casey, BSN, MPH (410-786-7861 ). Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (July through September 2014) Addendum XIV includes a listing of Medicare-approved facilities 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, Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices Addendum XI: National Oncologic PET Registry (NOPR) (July through September 2014) 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 perfonned 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 tacility that participates in the registry. There were no additions, deletions, or editorial changes to the listing ofNational Oncologic Positron Emission Tomography Registry (NOPR) in the July through September 2014 quarter. This infonnation is available at 17:37 Nov 13, 2014 facilities that meet our standards in the 3-month period. This information is available at Fmt 4703 VerDate Sep<11>2014 This information is available at For questions or additional infonnation, contact JoAnna Baldwin (410 786 7205). 68269 EN14NO14.016</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 68270 PO 00000 Frm 00062 Fmt 4703 Sfmt 9990 E:\FR\FM\14NON1.SGM 14NON1 Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (July through September 2014) There were no FOG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the July through September 2014 quarter. This information is available on our website at For questions or additional information, contact Stuart Caplan, RN, MAS (41 0-786-8564). Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices Jkt 235001 [FR Doc. 2014–26989 Filed 11–13–14; 8:45 am] 17:37 Nov 13, 2014 BILLING CODE 4120–01–C VerDate Sep<11>2014 EN14NO14.017</GPH> 2006, we issued our decision memorandum on bariatric surgery procedures. W c 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 with medical treatment for obesity. This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (I) certified by the American College of Surgeons (ACS) as a Levell 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 for bariatric surgery that have been certified by ACS and/or ASMBS in the July through September 2014 period. This information is available at For questions or additional information, contact Jamie Hermansen (410-786-2064).

Agencies

[Federal Register Volume 79, Number 220 (Friday, November 14, 2014)]
[Notices]
[Pages 68253-68270]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26989]



[[Page 68253]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9087-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--July Through September 2014

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 July through September 2014, relating 
to the Medicare and Medicaid programs and other programs administered 
by CMS.

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

------------------------------------------------------------------------
             Addenda                     Contact           Phone No.
------------------------------------------------------------------------
I CMS Manual Instructions........  Ismael Torres.....     (410) 786-1864
II Regulation Documents Published  Terri Plumb.......     (410) 786-4481
 in the Federal Register.
III CMS Rulings..................  Tiffany Lafferty..     (410) 786-7548
IV Medicare National Coverage      Wanda Belle.......     (410) 786-7491
 Determinations.
V FDA-Approved Category B IDEs...  John Manlove......     (410) 786-6877
VI Collections of Information....  Mitch Bryman......     (410) 786-5258
VII Medicare-Approved Carotid      Lori Ashby........     (410) 786-6322
 Stent Facilities.
VIII American College of           Marie Casey, BSN,      (410) 786-7861
 Cardiology-National                MPH.
 Cardiovascular Data Registry
 Sites.
IX Medicare's Active Coverage-     JoAnna Baldwin....     (410) 786-7205
 Related Guidance Documents.
X One-time Notices Regarding       JoAnna Baldwin....     (410) 786-7205
 National Coverage Provisions.
XI National Oncologic Positron     Stuart Caplan, RN,     (410) 786-8564
 Emission Tomography Registry       MAS.
 Sites.
XII Medicare-Approved Ventricular  Marie Casey, BSN,      (410) 786-7861
 Assist Device (Destination         MPH.
 Therapy) Facilities.
XIII Medicare-Approved Lung        Marie Casey, BSN,      (410) 786-7861
 Volume Reduction Surgery           MPH.
 Facilities.
XIV Medicare-Approved Bariatric    Jamie Hermansen...     (410) 786-2064
 Surgery Facilities.
XV Fluorodeoxyglucose Positron     Stuart Caplan, RN,     (410) 786-8564
 Emission Tomography for Dementia   MAS.
 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 Web site or the appropriate data 
registries that are used as our resources. This information is the most 
current up-to-date information and will be available earlier than we 
publish our quarterly notice. We believe the Web site list provides 
more timely access for beneficiaries, providers, and suppliers. We also 
believe the Web site offers a more convenient tool for the public to 
find the full list of qualified providers for these specific services 
and offers more flexibility and ``real time'' accessibility. In 
addition, many of the Web sites have listservs; that is, the public can 
subscribe and receive immediate notification of any updates to the Web 
site. These listservs avoid the need to check the Web site, as 
notification of updates is automatic and sent to the subscriber as they 
occur. If assessing a Web site proves to be difficult, the contact 
person listed can provide information.

III. How To Use the Notice

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

    Dated: November 7, 2014.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P

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[FR Doc. 2014-26989 Filed 11-13-14; 8:45 am]
BILLING CODE 4120-01-C

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