Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2014, 22976-22991 [2014-09288]

Download as PDF 22976 Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices Medicare Integrity Contractor (NBI MEDIC). Developed by Health Integrity, LLC and licensed for one of its contracts—the NBI MEDIC—PLATOTM utilizes a cutting-edge advanced analytics fraud detection process in conjunction with a state-of-the-art webbased user interface tool to present fraud and abuse lead information visually to Medicare Part D plan sponsors. Summary data, based on National Prescription Drug Event Data and actions from all Part D plan sponsors, is shared with law enforcement, CMS, NBI MEDIC, and Part D plan sponsors to review historic actions taken against providers who are enrolled in the Medicare Part D program, which will assist in detecting and preventing fraud, waste, and abuse. Form Number: CMS–10517 (OCN: 0938New); Frequency: Monthly; Affected Public: Private sector—Business or other for-profits and Not-for-profit institutions; Number of Respondents: 1,550; Total Annual Responses: 1,550; Total Annual Hours: 18,600. (For policy questions regarding this collection contact Delois Newkirk at 410–786– 1247). Dated: April 22, 2014. Martique Jones, Deputy Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2014–09505 Filed 4–24–14; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–21 and CMS– 21B] Agency Information Collection Activities: Submission for OMB Review; Comment Request ACTION: Notice. The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:57 Apr 24, 2014 Jkt 232001 other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by May 27, 2014. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395–5806 OR Email: OIRA_submission@omb.eop.gov. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ Web site address at http://www.cms.hhs.gov/ PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Quarterly Children’s Health Insurance Program (CHIP) Statement of Expenditures for the Title XXI Program (CMS–21) and State Children’s Health Insurance Program Budget Report for the Title XXI Program State Plan Expenditures (CMS– 21B); Use: Form CMS–21 and form CMS–21B provide CMS with the information necessary to issue quarterly grant awards, monitor current year expenditure levels, determine the allowability of state claims for reimbursement, develop Children’s Health Insurance Program (CHIP) financial management information, provide for state reporting of waiver expenditures, and ensure that the federally established allotment is not exceeded. Further, these forms are necessary in the redistribution and reallocation of unspent funds over the federally mandated timeframes. Form Number: CMS–21 and CMS–21B (OCN: 0938–0731); Frequency: Quarterly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 448; Total Annual Hours: 7,840. (For policy questions regarding this collection contact Abraham John at 410–786– 4519). Dated: April 22, 2014. Martique Jones, Deputy Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2014–09507 Filed 4–25–14; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9085–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—January Through March 2014 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2014, relating to the Medicare and SUMMARY: E:\FR\FM\25APN1.SGM 25APN1 Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 22977 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. I. Background 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. 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. VerDate Mar<15>2010 16:57 Apr 24, 2014 Jkt 232001 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 III. How To Use the Notice This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at http:// www.cms.gov/manuals. Authority: (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare— Hospital Insurance, Program No. 93.774, Medicare—Supplementary Medical Insurance Program, and Program No. 93.714, Medical Assistance Program) Dated: April 16, 2014. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. E:\FR\FM\25APN1.SGM 25APN1 EN25AP14.000</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) Furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective communications with CMS regional offices, state governments, state Medicaid agencies, state survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National Association of Insurance Commissioners (NAIC), health insurers, and other stakeholders. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act) and Public Health Service Act. We also issue various manuals, memoranda, and mstockstill on DSK4VPTVN1PROD with NOTICES 22978 VerDate Mar<15>2010 Publication Dates for the Previous Four Quarterly Notices Jkt 232001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4725 Addendum I: Medicare and Medicaid Manual Instructions (January through March 2014) The eMS Manual System is used by eMS program components, partners, providers, contractors, Medicare Advantage organizations, and State Survey Agencies to administer eMS 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 eMS Program Manuals into a web user-friendly presentation and renamed it the eMS Online Manual System. E:\FR\FM\25APN1.SGM 25APN1 How to Obtain Manuals The Internet-only Manuals (lOMs) are a replica of the Agency's official record copy. Paper-based manuals are eMS manuals that were officially rcleascd in hardcopy. Thc majority ofthesc manuals werc transfcrrcd into thc Intcrnct-only manual (10M) or retircd. Pub 15-1, Pub 15-2 and Pub 45 arc cxccptions to this rulc and arc still active paper-based manuals. Thc remaining paper-bascd manuals arc for rcfcrencc purposes only. If you notice policy contained in the paper-based manuals that was not transferred to the 10M, send a message via the eMS Feedback tool. Those wishing to subscribe to old versions of eMS 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: =ct=-'-,===_-,-,-,,===, Those wishing to review transmittals and program memoranda can access this information at a local Federal Depository Library (FDL). Under EN25AP14.001</GPH> Manual/Subject/Publication Number Update to Pub. 100-01, Chapter 7 for Language-Only Changes for ICD-IO . "tandard 179 180 Manual Updates to ClarifY Skilled Nursing Facility (SNF), Inpatient Rehabilitation Facility (lRF), Home Health (HH), and Outpatient (OPT) Coverage Pursuant to Jimmo vs. Sebelius Aprepitant for Chemotherapy Induced Emesis Oral Anti-Nausea (Anti-Emetic) Drugs Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 16:57 Apr 24, 2014 We publish this notice at the end of each quarter reflecting information released by eMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: May 3, 2013 (78 FR 26038) July 26, 2013 (78 FR 45233), November 8, 2013 (78 FR 67153) and January 31, 2014 (79 FR 5419). 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 hyperlink to the website to access this information and a contact person for questions or additional information. the FDL program, government publications are sent to approximately 1,400 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 information about the location of the nearest regional depository library from any library. eMS 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 Changes to the Laboratory National Coverage Detennination (NCD) Edit Software for April 2014 (lCD-lO) use eMS-pub. 100-04, Transmittal No. 2852. Addendum I lists a uniquc CMS transmittal number for each instruction in our manuals or program memoranda and its subject number. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use infornlation in a transmittal in conjunction with infonnation 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 ..:.:...::.:...:.:-'-"-'==~"'-"'==~. mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Mar<15>2010 181 Jkt 232001 PO 00000 Frm 00037 Fmt 4703 ['r:;~s\;j\{? 159 ;~;~>{:'!~~\5" Sfmt 4725 E:\FR\FM\25APN1.SGM 25APN1 Pub 100-03, Chapter I, language-only update Foreword Purpose for National Coverage Determinations (NCD) Manual Routine COqts in Clinical Trials (Fffective .luly 9, 2007 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 Services Transtelephonic Monitoring of Cardiac Pacemakers Electrocardiographic Services Cardiac Output Monitoring By Thoracic Electrical Bioimpedance (TEB) Various Effective Dates Below Speech Generating Devices Cochlear Implantation (Effective April 4, 2005) Physician's Office Within an Imtitution - Coverage of Services and Supplies Incident to a Physician's Services Hospital and Skilled Nursing Facility Admission Diagnostic Procedures Hydrophilic Contact Lens for Corneal Bandage Photodynamic Therapy Ocular Photodynamic Therapy (OPT) - Eftective April 3, 2013 Photosensitive Drugs Verteporfin - Effective April 3, 2013 Hydrophilic Contact Lenses Laproscopic Cholecystectomy Certain Drugs Distributed by the National Cancer Institute Stem Cell Transplantation (Various Effective Dates Below Anticancer Chemotherapy for Colorectal Cancer (Effective JanualY 28, 20(5) Aharelix for the Treatment of Prostate Cancer (Effective March 15,2005) Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions Inpatient Hospital Stays for the Treatment of Alcoholism Chemical Aversion Therapy t()r Treatment of Alcoholism lese of Visual Tests Prior to and General Anesthesia During Cataract Surgery Withdrawal Treatments for Narcotic Addictions Laser Procedures Diathermy Treatment Lumbar Artificial Disc Replacement (LADR) (Effective August 14, 2007) Induced Lesions of Nerve Tracts Electrical Nerve Stimulators Supplies Used in the Delivery of Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Enteral and Parenteral Nutritional Therapy Nesiritide for Treatment of Heart Failure Patients (Effective March 2, 2006) Nebulized Beta Adrenergic Agonist Therapy for Lung Diseases - (Effective September 10, 2007 Screening PAP Smears and Pelvic Examinations for Early Detection of Cervical or Vaginal Cancer Computed Tomography (CT) Magnetic Resonance Imaging (MRl) (Various Effective Dates Below) Ultrasound Diagnostic Procedures (Effective May 22, 2007) FDG Positron Emission Tomography (PET) for Dementia and Neurodegenerative Diseases (Effective September 15, 2004) Positron Emission Tomography (PET) (FDG) for Oncologic Conditions (Various Effective Dates) 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 Treatment of Drug Abuse (Chemical Dependency) Wounds(Effective July 1,2004) Durahle Medical Equipment Reference List (Effective May 5, 2005) Hospital Beds Infusion Pumps Obsolete or Unreliable Diagnostic Tcsts Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 16:57 Apr 24, 2014 182 Pub. 100-02 Language-Only Update for ICD-I 0 Admission Requirements Partial Hospitalization Services Coverage oflntravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the Home Coverage of Outpatient Rehabilitation Therapy Services (Physical Therapy, Occupational Therapy, and Speech-Language Pathology Services) Under Medicallnsurallce Documentation Requirements for Therapy Services Glaucoma Screening Determining Whether or Not the Beneficiary is at High Risk for Developing Colorectal Cancer Screening Pap Smears Limitations for Coverage Implementing the Part B Inpatient Payment Policies from CMS-J599-F Medical and Other Health Services Furnished to Inpatients of Hospitals and Skilled Nursing Facilities Reasonable and Necessary Part A Hospital Inpatient Claim Denials Other Circumstances in Which Payment Cannot Be Madc Under Part A Hospital Inpatient Services Paid Only Under Part B Medical and Other Heahh Services Furnished to SNF Patients Medical and Other Health Services Furnishcd to Inpatients of Participating Ilospitals 22979 EN25AP14.002</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 22980 VerDate Mar<15>2010 160 Jkt 232001 162 163 PO 00000 164 Frm 00038 l~:<i~ 2850 ;:(, 'e,'","",,',,: Fmt 4703 Sfmt 4725 E:\FR\FM\25APN1.SGM 25APN1 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Common Edits and Enhancements Modules (CEM) Code Set Update Changes to the Laboratory National Coverage Determination (NCO) Edit Software for April 2014 (ICD-IO) Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) - April 2014 New Waived Tests Remittance Advice Remark and Claims Adjustment Reason Code and Medicare Remit Easy Print and PC Print Update Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Hcalthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLlA) Edits Claim Status Category and Claim Status Codes Update Applying the Therapy Caps to Critical Access Hospitals Part B Claims Submission under the Indirect Payment Procedure (lPP) 2014 Durable Medical Equipment Prosthetics, Orthotics, and Supplies Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction List 2014 Durable Medical Equipment Prosthetics, Orthotics, and Supplies Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction List Where to Report Modifiers on the Hospital Part B Claim General Rules for Reporting Outpatient Hospital Services Billing of General Rules for Reporting Outpatient Hospital Services or Autologous Stem Cell Transplants Optional Method for Outpatient Services: Cost-Based Facility Services Plus 2863 2864 2865 2g66 2867 2868 -~~--------~-"-"----~- 2851 2852 2853 2854 2855 2856 2857 2858 2859 2860 2861 2869 2870 2871 2872 115 percent Fee Schedule Payment for Professional Services Billing and Payment in a Physician Scarcity Area (PSA) Optional Method for Outpatient Services: Cost-Based Facility Services Plus 115 percent Fce Schedule Payment for Professional Services Identifying Primary Care Services Eligible for the PCIP Rill Review for Partial Hospitalization Services Received in Community Mental Health Centers (CMIlC) Line Item Dale of Service Reporting for Partial Hospitalization April 2014 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files Additional Data Reporting Requirements for Hospice Claims Data Required on the Institutional Claim to Medicare Contractor Changes to the Laboratory National Coverage Determination (NCO) Software for ICD-IO Codes Enforcement ofthe 5 day Payment Limit for Respite Care Under the Hospice Medicare Renefit Enforcement of the 5 day Payment Limit for Respite Care Under the Hospice Medicare Benefit Therapy Modifier Consistency Edits Application of Financial Limitations Discipline Specific Outpatient Rehabilitation Modifiers - All Claims Reporting of Service Units With HCPCS Rebilling Therapy Services for Hospital Inpatients Issued to a specific, audience not posted to Internet! Intranet due to Sensitivity of Instruction Addition of New Fields and Expansion of Existing Model I Discount Percentage Field in the Inpatient Hospital Provider Specific File (PSF) and Addition of New Fields and Renaming Payment Fields in the Inpatient Prospective Payment System (lPPS) Pricer Output Medicare National Coverage Determination (NCD) for Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease Coverage for PET Scans for Dementia and Neurodegenerative Diseases National Coverage Determination (NCO) for Single Chamber and Dual Chamber Permanent Cardiac Pacemakers Billing Requirements for Cardiac Pacemakers: Single and Dual Chamber Cardiac Pacemakers: Single and Dual Chamber Policy Cardiac Pacemaker Healthcare Common Procedure Coding System (HCpeS Codes Cardiac Pacemaker Covered ICD-9/ICD-l 0 Diagnosis Codes Cardiac Pacemaker Claims Require the KX Modifier Cardiac Pacemaker Claims Without the KX modifier Cardiac Pacemaker Non Covered ICD-9/ICD-l 0 Diagnosis Codes Cardiac Pacemaker Claims Non Covered ICD-9/ICD-IO Diagnosis Codes: Denial Messages Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 16:57 Apr 24, 2014 161 2862 EN25AP14.003</GPH> Medicare National Coverage Detennination (NCD) for Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease National Coverage Determination (NCD) for Single Chamber and Dual Chamber Permanent Cardiac Pacemakers Single and Dual Chamber Permanent Cardiac Pacemakers Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid Tumors Positron Emission Tomography (FDG PET) for Oncologic Conditions Aprepitant for Chemotherapy Induced Emesis Oral Agents for Chemotherapy-Induced Emesis Medicare National Coverage lJetennination (NCO) for Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease Beta Amyloid Positron Emission Tomography in Dementia and N, nmrlpopner'ltive Disease mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Mar<15>2010 2873 Jkt 232001 PO 00000 2875 Frm 00039 2876 Fmt 4703 2877 Sfmt 4725 E:\FR\FM\25APN1.SGM 2878 25APN1 2879 2880 2881 2882 2883 2884 2885 2XX6 2887 2888 2889 2XYO 2891 2892 2893 2894 2895 2896 2897 2898 Billing and Payment Instructions for A/B MAC or Fls HCPCS Codes for Oral Anti-Emetic Drugs Claims Processing Jurisdiction for Oral Anti-Emetic Drugs Oral Anti-Emetic Drugs Used as Full Replacement for Intravenous AntiEmetic Drugs as Part of a Cancer Chemotherapeutic Regimen Claim Status Category and Claim Status Codes Update Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to InterneVlntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnstruction Healthcare Provider Taxonomv Codes (HPTC) Update, April 2014 Common Edits and Enhancements Modules (CEM) Code Set Update Health Protessional Shortaae Area (HPSA) Post-payment Review Process Instructions for Downloading the Medicare ZIP Code File for July 2014 Quarterly Update to the Correct Coding Tnitiative (CCI) Edits, Version 20.2, EfTective July 1,2014 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction April 20 14 Update of the Hospital Outpatient Prospective Payment System (OPPS) Update to Pub. 100-04. Chapter 19 to Provide Language-Only Changes for ICD-IO and ASC X12 FI - Inpatient Acute Care - Medicare Part A - Claims Processing FI Payment Policy and Claims Processing Indirect Payment Procedure (lPP) - Payment to Entities that Provide Coverage Complementarv to Medicare Part J3 Indirect Payment Procedure (11'1') - Payment to Entities that Provide Coverage Complementary to Medicare Part B Update to Pub. 100-04 Chapter 13 to Provide Language-Only Changes for Updating ICD-IO and ASC XI2 ICD Coding for Diagnostic Tests Place of Service (POS) Instructions for the Professional Component (PC or Interpretation) and the I'echnical Component (TC) of Diagnostic Tests 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 Billing Requirements for CMS - Approved Clinical Trials and Coverage With Evidence Development Claims for PET Scans for Neurodegenerative Diseases, Previously Specified Cancer Indications, and All Other Cancer Indications Not Previously Specified Billing and Coverage Changes for PET Scans Effective for Services on or After April 3, 2009 Billing and Coverage Changes for PET Scans for Cervical Cancer Effective for Services on or After November 10, 2009 Billing and Coverage Changes for PET (KaF-18) Scans to IdentifY Bone Metastasis of Cancer Effective for Claims With Dates of Services on or After Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 16:57 Apr 24, 2014 2874 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid Tumors Billing Requirements for CMS-Approved Clinical Trials and Coverage with Evidence Development Claims for PET Scans for Neurodegenerative Diseases, Previously Specified Cancer Indications, and All Other Cancer Indications Not Previously Specified Billing and Coverage Changes for PET Scans Medicare Claims Processing Pub. 100-04 Chapter 25 Update Form Locators 43-81 l;niform Billing with Form CMS-1450 Disposition of Copies of Completed Forms General Instructions for Completion of Form CMS-1450 for Billing Form Locators 1-15 Form Locators 31-41 Uniform Bi11- Form CMS-1450 Issued to a specific audience, not posted to Internet/Intranet due to Contidentiality of Instruction Update to Pub 100-04, Claims Processing Manual, Chapter One Section 20.3/CMS No Longer Accepts Provider Requests For A Change of Fiscal Intermediary Solicitation of a Provider to Secure a Change of Fiscal Intermediary Communications CMS No Longer Accepts Provider Requests to Change Their Fiscal Intermediary Implementing the Part B Inpatient Payment Policies from CMS-1599-F Payment of Part B Services in the Payment Window for Outpatient Services Treated as Inpatient Services when Part A Payment Cannot Be Made Inpatient Part B Hospital Services Editing Of Hospital Part B Inpatient Services: Reasonable and Necessary P31i A Ilospitallnpatient Denials Editing Of Hospital Part B Inpatient Services: Other Circumstances in Whieh Payment Cannot Be Made under Part A Implantable Prosthetic Devices Indian Health Service/Tribal Hospital Inpatient Social Admits Payment Window for Outpatient Services Treated as Inpatient Services Correction CR - Advance Beneficiary Notice of None overage (ABN), Form CMS-R-131 ABN Scope flome Health Agency Use ofthe ABN General Notice Preparation Requirements 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 InternellIntranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Aprepitant for Chemotherapy Induced Emesis Aprepitant for Chemotherapy Induced Emesis 22981 EN25AP14.004</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 22982 VerDate Mar<15>2010 Jkt 232001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\25APN1.SGM 25APN1 EN25AP14.005</GPH> 2900 2901 2902 2903 2904 2905 2906 Beginning January 1,2008 Drugs, Biologicals, and Radiopharmaceuticals Reporting and Charging Requirements When a Device is Furnished Without Cost to the Hospital Prior to January I, 2014 Update to Pub. 100-04, Chapter 16 to Provide Language-Only Changes for Updating ICD-IO and ASC XI2 Update to Pub. 100-04, Chapters 7 and 8 to Provide Language-Only Changes for Updating ICD-I0 and ASC XI2 Hilling 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 Prospt:ctive Payment System Rale In-Facility Dialysis Bill Processing Procedures Required Information tor In-Facility Claims Paid Under the Composite Rate and the ESRD PPS Payment for lIemodialysis Sessions Ultrafiltration Lab Services Separately Billable ESRD Drugs Physician Billing Requirements to the Carrier Other Information Required on the Form CMS-ISOO for Epoetin Alfa (EPO) Other Infonnation Required on the Form CMS-1500 for Darbepoetin Alfa (Aranesp) (Jeneral Intermediary Rill Processing Procedures for Method I Home Dialysis Services Physician'S Services Furnished to a Dialysis Patient Away From Home or Usual Facility Physicians and Supplier (Nonfacility) Billing for ESRD Services/General Hilling tor Durable Medical Equipment (DME), OrthoticiProsthetic Devices, and Supplies (including Surgical Dressings) Pub 100-04, Chapter 28 language-only update for ASC XI2 version 5010. implementation ofMACs, and MAC coordination with Medigap, \1edicaid and Other Complementary Insurers. Medigap! Definition and Scope Assignment of Claims and Transfer Policy Requirements as of.luly 2012 Completion of the Claim Form Form CMS-ISOO/ ASC X 12 837 Professional COB Form CMS-1450/ASC XI2 837 Institutional COB MSN Messages Remittance Notice Mcssages Returned Mcdigap Notices Coordination of Medicare With Medigap and Other Complementary Health Insurance Policies Requests for Additional Information Release of Title XVIII Claims Information for \1edigap Insurance Purposes by Providers Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 16:57 Apr 24, 2014 2899 february 26,20 10 EMC Formats Payment Methodology and HCPCS Coding fI Payment for Low Osmolar Contrast \1aterial (LOCM) (Radiology) Pub 100-04, Language Only Update for Chapters Five and Six for Conversion toICD-IO Other Billing Situations Appli~ation 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 CORf 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 Billing 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 Benefits Exhaust and No-Payment Situations Part B Outpatient Rehabilitation and Comprehensive Outpatient Rehabilitation Facility (CORF) Services ~ General April 2014 Integrated Outpatient Code Editor (VOCE) Specifications Version 15.1 April 2014 Update of the Ambulatory Surgical Center (ASC) Payment System April 20 14 Update of the Ambulatory Surgical Center (ASC) Payment System April 2014 Update of the Hospital Outpatient Prospective Payment System (OPPS) Composite APCs HCPCS Codes Replacements Reporting and Charging Requirements When the Hospital Receives Full Credit lor the Replaced Device against the Cost of a More Expensive Replacement Device Prior to January I, 2014 Reporting Requirements When the Hospital Receives Partial Credit for the Replacement Device Prior to January I, 2014 Medicare Payment Adjustment Prior to January 1,2014 Reporting and Charging Requirements When a Device is furnished Without Cost to the Hospital or When the Hospital Receives a Full or Partial Credit tor the Replacement Device Beginning January I, 2014 Medicare Payment Adjustment Beginning January I, 2014 Billing and Payment for Observation Services Beginning January I. 2008 Billing and Payment for Direct Referral for Observation Care Furnished mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Mar<15>2010 Jkt 232001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\25APN1.SGM 2908 25APN1 2909 Summary of the ASC XI2 276/277 Claim Status Request and Response Process for A/I3 Medicare Administrative Contractors, DME MACs, CEDI Flat File Translation Requirements Transmission Mode Health Care Eligibility Benefit Inquiry and Response Implementation 2910 Update to Pub. 100-04. Medicare Claims Processing Manual, Chapter 11 to Provide Language-Only Changes for Updating lCD-to and ASC X12 Completing the Uniform \Institutional Provider) Bill (Form CMS 1450) for Hospice Election Data Required on the Institutional Claim to Medicare Contractor Medicare Summary Notice (MSN) Messages/ ASC X12 Remittance Advice Adjustment Reason and Remark Codes 2911 Manual Updates to Clarify Skilled Nursing Facility Advanced 13cneiiciary Notice (SNF ABN) Requirements Pursuant to Jimmo vs. Scbelius Proper Denial Paragraphs 2912 April Update to the CY 2014 Medicare Physician Fee Schedule Database (MPFSDB) 2913 Issued to a specitic audience, not posted to Internet/Intranet due to Confidentiality oflnstruction 2914 Health Professional Shortage Area (I IPSA) Post-payment Review Process Post-payment Review 2915 Medicare National Coverage Determination (NCD'! for Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegencrative Disease Coverage for PET Scans for Dementia and Neurodegenerative Diseases Calendar Year (CY) 2014 Annual Update for Clinical Laboratory Fee 2916 Schedule and Laboratory Services Subject to Reasonable Charge PaymentREVISION 2917 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction ,\: ii' '\;\,;;\'ls' ;~£~:'li~~';0~\ ::\1~\\l>0 ;:,11:< 99 Apply Front-End Edits to Electronic Correspondence Referral System (ECRS) Files Submitted Via ECRS Web and PDR Assistance Request Action Code J3N COBC Electronic Correspondence Referral System (ECRS) 100 The Medicare Contractors and the Shared Systems Shall Send the Correct Cost Avoided Indicator and Special Project Type to the Common Working File (CWF) so the Correct Savings is applied both to the Medicare Secondary Payer (MSP) Savings Report and the Originating Contractor ,;~:~t::(,\jf::\::~);;;i;i,; '~ 230 231 232 '\:," 99 :T\;;,\;~,;,,~k;'jl:;\i'i' 0~i, Notice of :--Jew Interest Rate for Medicare Overpayments and Underpayments-2nd qtr Notification for FY 2014 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 {i;!C~ Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 16:57 Apr 24, 2014 2907 Standard Medicare Charges for COB Records General Guidelines for A/13 MAC (A, 13, or HH) or DME MAC Transfer of Claims Information to Mcdigap Insurers Consolidation of the Claims Crossover Process Coordination of Benefits Agreement (COBA) Detailed Error Report Notification Process Coordination of Benetits Agreement (COBA) ASC X12 837 5010 Coordination of Benefits (COB) Flat File Errors Coordination of Bcncfits Agreement (COBA) Full Claim File Repair Process Coordination of Benefits Agreement (COBA) Eligibility File Claims Recovery Process Coordination of Benefits Agreement (COB A) Medigap Claim-Based Crossover Process Coordination ofI3enefits Agreement (COI3A) ASC Xl2 837 Coordination of Benefits (COB) Mapping National Council for Prescription Drug Programs (NCPDP) Version D.O Coordination of Benefits (COB) Mapping Requirements Electronic Transmission/ General Requirements Reserved Reserved Bencficiary Insurance Assignment Selection AlB MAC (A) Crossover Claim Requirements B MAC/DME MAC Crossover Claim Requirements Reserved Medigap Insurers Fraud Refen'al Outline of Complaint Referral Process Medigap Electronic Claims Transfer Agreements Clinical Laboratory Fee Schedule - Medicare Travel Allowance Fees for Collection of Specimens Travel Allowance Update to Pub. 100-04. Chapter 15 to Provide Language-Only Changes for Updating [CD-IO and ASC XI2 Medical Conditions List and Instructions General Billing Guidelines Coding Instructions for Paper and Electronic Claim Forms Fiscal Intermediary Shared System (FISS) Guidelines A/MAC Bill Processing Guidelines Effective April 1,2002, as a Result of Fee Schedule Implementation Detinition Medicare Claims Processing Pub. 100-04 Chapter 31 Update Health Care Claim Status Category Codes and Health Care Claim Status Codes for Use with the Health Care Claim Status Request and Response ASC X12 Claim Status Request and Response Background Eligihility Connectivity Workflow Claim Status Request/Response Transaction Standard Transmission Requirements Batch Transactions Online Direct Data Entry Interactive/Online (Non-DDE) ~,::;S\i:L:: "::::: ;\,i i'" Revised State Operations Manual (SOM) Appendices A, T, L, and W 22983 EN25AP14.006</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 22984 VerDate Mar<15>2010 Jkt 232001 505 506 PO 00000 507 508 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\25APN1.SGM 509 00 Disputing/Disagreeing With a CERT Decision Voluntary Refunds Handling Appeals Resulting From CERT Initiated Denials CERT Appeal Results Disseminating CERT Information Error Rate Reduction Plans (ERRPs) Contacting Non-Responders & Documentation Requests Late Documentation Received by the CERT Review Contractor Handling Overpayments and Underpayments Resulting From the CERT Removing Prohibition Requesting Additional Documentation During Prepayment and Postpayment Review Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality oflnstruction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Supplemental Medical Review Contractor Overview of Program Integrity and Provider Compliance Medicare Improper Payment Reduction Efforts - Provider Compliance Types of Contractors Improper Payment Prevention Goals Applicable Program Integrity Manual Sections Performance Metrics Types of Claims for Which Contractors Are Responsible Quality of(~are Issues and Potential Fraud Issues The MAC and SMRC Medical Review Program Goal of MAC and SMRC MR Program Provider Self Audits Coordination Among Contractors Maintaining the Confidentiality of MR Medical Records and Documents Medical Review Manager Contractor Medical Director (CMD) Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnstruction None 'l;;I,;,.,; i~':;2;{'ii< 00 :\Y 25APN1 116 None i.•'; ,sj;i;.;i~) r,1';i;::·.:>:\s:~:.1~~~;Ci';i'B\i;Z;:ili~ Conversion from ICD-9 to ICD-IO and from ASC XI2 Version 4010 to 5010 Expanded Alternative Verification Methodology Calibration ofthe CMS-HCC Risk Adjustment Models Model Similarities Operations Sources of Data Format Diagnosis Cluster Valid Diagnosis Codes Health Insurance Portability and Accountability Act (HIPAA) Glossary of Terms Rules for Payment of"Signific3nt Cost" NCDs and LCBs Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 16:57 Apr 24, 2014 EN25AP14.007</GPH> State Operations Manual (SOM) Appendix AA revisions for Intermediate Care Facilities for Individuals with Intellectual Disabilities (lCFIIIDJ. Psychiatric Hospitals-Interpretive Guidelines and Survey Procedures/Title AA-Psychiatric Hospitals-Interpretive Guidelines and Survey Procedures/BI12/§482.61(b)(2) Include a Medical History 101 State Operations Manual (SOM) Appendix I revisions for Intermediate Care Facilities tor Individuals with Intellectual Disabilities (ICFIlID) II-Survey Procedures and Interpretive Guidelines for Life Safety Code Surveys/Part [I-Interpretive Guidelines/ll. The Survey Tasks/Task 4Infonnation Gathering I-Survey Procedures and Interpretive Guidelines for Life Safety Code Surveys/Part II-Interpretive Guidelines/II. The Survey Tasks/Task 2Entrance Conference/On site Preparatory Activities I-Survey Procedures and Interpretive Guidelines for Life Safety Code 102 State Operations Manual (SOM) Appendix Q revisions for Intermediate Care Facilities lor Individuals with Intellectual Disabilities (ICF/IID). Q-Guidelines for Determining Immediate Jeopardy/Attachment C-Overview Recommended Key Components of Systemic Approach to Prevent Abuse and Neglect Q-Guidelines for Determining Immediate Jeopardy/Attachment A Q-Guidelines f1.Jr Determining Immediate JeopardyIVIII-Enforcement! ATermination for Title XIX-Only NFs, ICFs!lID Revised State Operations Manllal (SOM) Hospital Appendix A 103 Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. 104 State Operations Manual (SOM) Appendix M revisions for Intermediate Care Facilities tor Individuals with Intellectual Disabilities (lCFIIID) Revised Annpnri;y A, Interpretive Guidelines lor Hospitals, Condition of 105 Participatioll: Quality Assessment and Performance it!;(\ i.Vi ·,;1, \;~;i ':,;,;: \R';C':" '}{':\';~~;;;i,\~:1':;@;;\':~1~~;\ 501 Complex Medical Review Registration o[Entities Using the Indired Payment Procedure (lPP) 502 Registration Letters Indirect Payment Procedure Background Submission of Registration Applications Processing of Registration Applications Disposition of Registration Applications Revocation of Registration Changes of Information and Other Registration Transactions Indirect Payment Procedure Inter-Jurisdictional Reassignments 503 Revision to Chapter 12 of the Medicare Program Integrity Manual- The 504 Comprehensive Error Rate Testing Program. The Comprehensive Error Rate Testing (CERT) Program MAC Communication with the CERT Program Overview of the CERT Process Providing Sample Information to the CERT Review Contractor Providing Review Information to the CERT Review Contractor MAC Responsibility After Workload Transition Providing Feedback Information to the CERT Review Contractor 100 mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Mar<15>2010 .. ~:i\,~C))'l 1349 1350 Jkt 232001 PO 00000 ,~, ,!),,!,y;;,:\.;~:;.~>~~. 1351 Z:·:J\\\~,·i;~·::;:\;\},> '.:\i."\;;'·."~{; rRi :rl''';''~':~\~::·t'! \Y."'Y~:,;ii .• ~s~; 94 Affordable Care Act Bundled Payments for Care Improvement Initiative Recurring File Updates Models 2 and 4 April 2014 Update Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 95 oflnstruction 96 Issued to a speciJic audience, not posted to Internet/Intranet due to Confidentiality of Instruction MAPCP Demonstration - Update for ICD-IO 97 1352 00 k~ \;',:;:.';.;~:.< 1332 Frm 00043 1333 Fmt 4703 [~35 1334 1336 Sfmt 4725 1337 E:\FR\FM\25APN1.SGM 1338 1339 [340 1341 25APN1 1342 1343 1344 [345 1346 1347 1348 None ',.' ~:\~;;\\,;; .' ,.,{./jiL.!l'll¥ < ·,i,~i;;;::". 1353 1354 1355 :i:;\\);.\';'0:',i\\lij\;;,~\.~••":: Rescind and Replace of CR 8409: Reclassification of Certain Durable Medical Equipment from the Inexpensive and Routinely Purchased Payment Category to the Capped Rental Payment Category Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Occurrence Span Code 72; Identification of Outpatient Time Associated with an Inpatient Hospital Admission lmd Inpatient Claim for Payment Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Modifying the Daily Common Working File (CWF) to Medicare Beneficimy Database (MBD) File to Include Diagnosis Codes 011 the Health Insurance Portability and Accountabi[ity Act Eligibility Transaction System (HErS) 270/271 Transactions Encounter Data System Payer 10: Payer ID Creation for the Financial Alignment Demonstration for Medicare Medicaid Plans (MMPsJ Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction CWF Editing for Vaccines Furnished at Hospice - Correction Health lllsurance Portability and Accountability Act (HIPAA) EDI Front End Updates for July 2014 Changing Fiscal Intennediary Shared System (FfSS) Action on Informational Unsolicited Responses (I U Rs) From Canceled Claims to Adjustments Reporting principal and inkrest amounts when refunding previously recouped money on the Remittance Advice (RAJ Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Fee for Service Beneficiary Data Streamlining (FFS BDS) Implementing Operating Rule (OR)-Phase 1Il ERA Or Dual Delivery of ERA and Paper Remittance 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 Handling Bankrupt Suppliers within VMS 1356 1357 1358 1359 13()O 1361 1362 1363 Implementation ofNACHA Operating Rules [or Health Care Electronic Funds Transfers (EFT) Clarification of Remittance Advice Code Combination Reports Generated by Shared Systems [mplementation ofHIPAA Standards and Operating Rules for Health Care Electronic Funds Transfers Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity ofInstruction Interuational Classification of Diseases, lOth Revision (ICD-IO) Testing with Providers through the Common Edits and Enhancements Module (CEM) and Common Electronic Data Interchange (CEDI), Issued to a speciJic audience, not posted to Internet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnstruction ModifYing the Daily Common Working File (CWF) to Medicare Beneficiary Database (MBD) File to Include Diagnosis Codes on the Health Insurance Portability and Accountability Act Eligibility Transaction System (HETS) 270/271 Transaction [nternational Classification of Diseases, 10th Revision (ICD-10) Testing with Providers through the Common Edits and Enhancements Module (CEM) and Common Electronic Data Interchange (CEDI) Implement Operating Rules-Phase !II ERA EFT: CORE 360 Uniform Use of Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark Codes (RARC) Rule-Update from CAQH CORE-Oct. 1,2013 version 3.0.3 The Coordination of Benefits Contractor (COBC) to Remove and No Longer Apply Federal Tax Information (FTf) Received through the Internal Revenue Service (IRS), Social Security Administration (SSA), Centers for Medicare and Medicaid Services (eMS) Medicare Secondary Payer (MSP) Data Match Program 011 the Common Working File (CWF). Implement Operating Rules-Phase 1II ERA EFT: CORE 360 I lniform IJse of Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark Codes (RARC) Rule-Update from CAQH CORE-Oct. 1,2013 version 3.0.3 Implementation ofNACHA Operating Rules for Health Care Electronic Funds Transfers (EfT) Rescind and Replace ofCR 8409: Reclassitication of Certain Durable Medical Equipment from the Inexpensive and Routinely Purchased Payment Category to the Capped Renla I Payment Catego 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 from CAQH CORE-Feb. 1,2014 version 3.0.4 Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 16:57 Apr 24, 2014 Special Rules for the September 2000 NCD on Clinical Trials Category B Investigational Device Exemption (IDE) Trials Adjustment to MA Payments Under the CMS-HCC Risk Adjustment Models Role and Responsibilities of Plan Sponsors Issued to a specitic audience, not posted to Internet/Intranet due to Sensitivity ofInstruction 22985 EN25AP14.008</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 22986 VerDate Mar<15>2010 Jkt 232001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4725 For questions or additional information, contact Terri Plumb (410-786-4481). E:\FR\FM\25APN1.SGM 25APN1 Addendum III: CMS Rulings CMS Rulings are decisions of the Administrator that serve as precedent tinal 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 Ull/J.IIWWW'\';"''''!:fUV;r\.''!bUIdUUU:SFor questions or additional information, contact Tiffany Lafferty (410-786-7548). Addendum IV: Medicare National Coverage Determinations (January through March 2014) Addendum IV includes completed national coverage dctcrminations (NCDs), or rcconsidcrations of completcd NCDs, from thc 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 of the EN25AP14.009</GPH> decision. An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII ofthe Act), but does not include a determination of the code, if any, that is assigned to a particular covered item or service, or payment determination for a particular covered item or service. The entries below include information concerning completed decisions, as well as sections on program and decision memoranda, which also announce decisions or, in somc cascs, cxplain why it was not appropriatc to issuc an NCD. Infornlation 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: ~~~~~~!m:~~~~~1!g!"c For questions or additional information, contact Wanda Belle (4lO-786-7491). Title PET (FOG) for Solid Tumors Beta Amyloid PET in Dementia! Neurodenerative Disease Single-Chamber/DualChamber Permanent Cardiac Pacemakers Aprepitant tor Chemotherapy-Induced Emesis NCDM Section NCD220.6.17 Transmittal Number Issue Date Effective Date TRI62 02/06/2014 0611112013 NCO 220.6.18 TN160 02/06/2014 09/27/2013 NCD20.8 TN 161 02/06/2014 08113/2013 02/21/2014 0512912013 NCDllO.18 TNI63 , , Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (January through March 2014) Addendum V includes listings ofthe 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 ofthis quarterly notice, we list only the specific updates to the Category B IDEs as of the ending date of the period covered by this notice and a contact person for questions or additional infornlation. 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 Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 16:57 Apr 24, 2014 Addendum II: Regulation Documents Published in the Federal Register (January through March 2014) Regulations and Notices Regulations and notices are published in the daily Federal Register. To purchase individual copies or subscribe to the Federal Register, contact GPO at When ordering individual copies, it is necessary to cite either the date of publication or the volume numbcr and pagc numbcr. The Federal Register is available as an onlinc database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) through the present date and can be accessed at The following website provides information on how to access electronic editions, printed editions, and reference copies. This information is available on our website at: mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Mar<15>2010 IDE Jkt 232001 0130288 PO 00000 Frm 00045 0130292 0130300 UI30132 0130237 0110303 0140003 0130248 U13022~ 0130127 0140006 Fmt 4703 Sfmt 4725 Device Medtronic Activa PC+S System Cook Custom Aortic Endograft and Zenith t-Branch Endovascular Graft EXOGEN Ultrasound Bone Healing System Fucused Ultrasuund Stimulatur Fur Aesthetic Use lherapy Cool Flex Ablation Catheter Embosphere Microspheres Concert Implant Essure System for Permanent Birth Control SIR-Spere Microspheres SIR-Spheres :viicrospheres Brachytherapy Device Plus Delivery VIOl ICV Filter System Medtronic Tined Leads (Models 3889 and 3093) and the Medtronic Restoreprime Neurostimulatory (Model 37701) LUTONIX 035 Drug Coated Balloon PTA Catheter Nucleus 24 Auditory Brainstem Implant (ABI) Micra Transcatheter Pacemaker System Model MCI VROI Embozene Microspheres BrainSonix BX Pulsar 1001 Focused Ultrasonic Sentinel Cerebral Protection System Embospherc E:\FR\FM\25APN1.SGM 25APN1 0130244 GI40001 0130245 0130278 G130290 G130276 GI30205 0130172 ---------- _~i~~_3'YS~~!lI________ 0140014 RMY Contact Lens 0140013 FAME 3 Vascular Embolization Device GI30190 BB15909 Emergency Use - Treatment of using Haploidcntical Parental Adenovirus Specific I-Cells using the CliniMACS System (Cytokine Capture Reagent, Interferon-gamma) Vascular Sealing System 0130213 lmplany, Cochlear GI40019 GI40020 Dako PD-L! IHC pharmDx kit 0140021 Toronto EVLP System 0140025 COST A TUS SYSTEM G130223 Concentric Medical, Inc 0130287 Microtransponder, Inc GI30034 BIOFREEDOM Drug Couted Coronary Sten! System 0140028 Teosyal RHA 010bal Action (TP30L), Teosyal RHA Deep Lines (TP27L) GI40030 Bcst-CLI Gl40032 MolecularMD MRDX BCR-ABL TEST Start Date 01/03/2014 01108/2014 01/22/2014 01/22/2014 01/24/2014 01/30/2014 0113112014 Oli3112014 01/3112014 02/04/2014 02/04/2014 02106/2014 02/07/2014 02110/2014 02/11/2014 02112/2014 02114/2014 02/14/2014 02/2112014 --------02/2112014 02/2112014 02/26/2014 02/27/2014 Addendum VI: Approval Numbers for Collections of Information (January through March 2014) All approval numbers are available to the public at Reginfo.gov. Under the review process, approved information collection requests are assigned OMB control numbers. A single control number may apply to several related inf0l11lation collections. This infol1nation is available at For questions or additional information, contact Mitch Bryman (410-786-5258). Addendum VII: Medicare-Approved Carotid Stent Facilities, (January through March 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 infonnation is available at: For questions or additional information, contact Lori Ashby (410-786-6322). 'F~cility 02/28/2014 03/05/2014 03/06/2014 03/06/2014 03/12/2014 03/20/2014 03/20/2014 03/25/2014 03/26/2014 03/27/2014 03/27/2014 b;.i~Yi!'~;:·._·,~t'~.\'k" Provider - - Effective Number Date . Capital Regional Medical Centcr 2626 Capital Medical Boulevard Tallahassee, FL 32308 Berwick Hospital Center 701 E. 16th Street Berwick, PA 18603 Texas Heart Health and Vascular Hospital Arlington 811 Wright Street Arlington, TX 76012 Doctors Hospital 3651 Wheeler Road Augusta, GA 30909 Baylor Medical Center at McKinney 5252 W. University Drive. Hwy 380 At Lake Forest Drive McKinney, TX 75071 State );~0::.\~.:~!; §;~t\y;~i' 100254 02/27/2014 1316919699 02/27/2014 670071 02/27/2014 TX 110177 03/05/2014 GA 670082 03/24/2014 Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 16:57 Apr 24, 2014 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 information about the classes or categories, please refer to the notice published in the April 21, 1997 Federal Register (62 FR 19328). TX FL --=--PA 22987 EN25AP14.010</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 22988 VerDate Mar<15>2010 Facility Jkt 232001 Effective Date 500050 05/26/2005 WA 230070 06/22/2006 MI 1~;\;s;;;.~ FROM: Southwest Wasbington Medical Center TO: Peace Health Southwest Medical Center 400 N.E. Mother Joseph Place Vancouver, WA 98668 P.O. Box 1600 Covenant Healthcare 900 Cooper Avenue Saginaw, :\,11 48602 State ,~;%i.ii.?\ Facility PO 00000 Frm 00046 Fmt 4703 Sfmt 4725 E:\FR\FM\25APN1.SGM 25APN1 Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (January through March 2014) Addendum Vlll includes a list ofthe American College of Cardiology's National Cardiovascular Data Registry Sites. We cover implantable cardioverter defibrillators (ICDs) for certain clinical indications, as long as information about the procedures is reported to a central registry. Detailed descriptions of the covered indications are available in the NCD. In January 2005, CMS established the ICD Abstraction Tool through the Quality Network Exchange (QNet) as a temporary data collection mechanism. On October 27, 2005, CMS announced that the American College of Cardiology 's National Cardiovascular Data Registry (ACC-NCDR) ICD Registry satisfies the data reporting requirements in the NCD. Hospitals needed to transition to the ACC-NCDR ICD Registry by April 2006. 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 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 TCDs 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 EN25AP14.011</GPH> registry. The entire list offacilities that participate in the ACC-NCDR ICD registry can be found at -"-'~~~"""'~-'-'-"'=-'-"-"'''-'''''''''''-'-''= 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 by accessing our website and clicking on the link for the American College of Cardiology's National Cardiovascular Data Registry at: For questions or additional information, contact Marie Casey, BSN, MPH (410-786-7861). City Carolina Pines Regional Medical Center Charlotte Regional Medical Center ~n & Country Hospital Crossgates River Oaks Hospital St. Cloud Regional ~cdical Center Summit Medical Center Saint Mary's Mercy Medical Center Fisher-Titus Medical Center University Medical Center Geisinger Community Medical Center Tulare District Hospital Lake "lorman Regional Medical Center Methodist Mansfield Medical Center University of Texas Health Science Center at Tyler Mercy Hospital Ada Hospital total Cor St. Luke's Warren Campus Castle Rock Adventist New York Presbyterian - Weill Cornell Medical Center Santa Rosa Medical Center Shands Lake Shore Regional Medical Center Bayfront Health Spring Hill Williamson Memorial Hospital Pine Creek Medical Center New York Presbyterian Hospital-Columbia Central Carolina (TENET) Saint Vincent Medical Center North Children's Hospital of Los Angeles Northbank Surgical Center Children's Hospital of Philadelphia Mary Lanning Healthcare Mercy Tiffin Hospital Wilson Medical Center Signature Healthcare Brockton Hospital Norton Brownsboro Hospital State ::~.;~. 0:;;;i\:\1~~\\\i~lt: }.;.,.~ii~;ii;\):~~;;'? Hartsville Punta Gorda Tampa Brandon Saint Cloud Van Buren Grand Rapids Norwalk Lebanon Scranton Tulare Mooresville Mansfield Tyler Ada Sao Paulo Phillipsburg Castle Rock New York Milton Lake City Spring Hill Williamson Dallas New York Sanford Little Rock Los Angeles Salem Philadelphia Hastin"s Tit1in Wilson Brockton Louisville SC FL FL MS FL AR MI OH TN PA CA NC TX TX OK Brazil NJ CO NY FL fL FL WV TX NY NC AR CA OR PA NE OH NC MA KY Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 16:57 Apr 24, 2014 Provider Number mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Mar<15>2010 Facility ~:i;~'\';\.\i;;:;)<~:z~~ State !uum:~{!:f.;::~»)~,\):: ·"!i~:··Y¥;\\;<f\3 Jkt 232001 Dallas Henderson Roswell Glenwood Springs Denton Carrollton Temecula Blue Springs ,;\i. ;.·.)g!;;.;f~~l.t\ '·it~)j·~~;;:·";1~~·.·\~) PO 00000 Oconee Regional Medical Center Charlotte Regional Medical Center Crossgates River Oaks Hospital Shands Lake Shore Regional Medical Center IX NV NM CO IX TX CA MO Milledgeville Punta Gorda Brandon Lake City GA FL perfonued in the context of a clinical study. We have since recognized the National Oncologic PET Registry as one of these clinical studies. Therefore, in order for a beneficiary to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the registry. There were no additions, deletions, or editorial changes to the listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the January through March 2014 quarter. This information is available at For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564). MS FL Frm 00047 Fmt 4703 Addendum IX: Active CMS Coverage-Related Guidance Documents (January through March 2014) 'Ihere were no CMS coverage-related guidance documents published in the January through March 2014 quarter. To obtain the document, visit the eMS coverage website at Sfmt 4725 For questions or additional information, contact Lori Ashby (410-786-6322). E:\FR\FM\25APN1.SGM Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (January through March 2014) There were no special one-time notices regarding national coverage provisions published in the January through March 2014 quarter. This information is available at For questions or additional information, contact Lori Ashby (410-786-6322). 25APN1 Addendum XI: National Oncologic PET Registry (NOPR) (January through March 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 Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (January through March 2014) Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (VADs) 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 I, 2003, we issued our decision memorandum on VADs for the clinical indication of destination therapy. We determined that V ADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastmchlre to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for V ADs implanted as destination therapy. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred to the list of Medicare-approved facilities that meet our standards in the 3-month period. This information is available at For questions or additional information, contact Marie Casey, BSN, MPH (410-786-7861). Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 16:57 Apr 24, 2014 Walnut Hill Medical Center Coronado SurgerY Center Eastern New Mexico Medical Center Valley View Hospital [he Heart Hospital Baylor Denton Baylor Medical Cenler Carrollton Temecula Valley Hospital St Mary's Medical Center City Provider Number Moses H. Cone Memorial Hospital 1200 North Elm Street Greensboro NC 27401-1020 Mercy General Hospital 4UUl .J Street Sacramento. CA 95819 340091 050071 02/12/2014 CA 22989 EN25AP14.012</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 22990 VerDate Mar<15>2010 39-0270 02/26/2014 PA 190176 03/15/2013 LA 150056 11125/2003 i,1\;;i~;' Jkt 232001 FROM: Clarian Health Partners, Inc. (Methodist Hospital) TO: Indiana University Health, Inc. 1701 N. Senate Boulevard Indianapolis. IN 46206 '\',;\\,}i': IN PO 00000 Frm 00048 Fmt 4703 Sfmt 9990 E:\FR\FM\25APN1.SGM 25APN1 Addendum XIII: Lung Volume Reduction Surgery (LVRS) (January through March 2014) Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17,2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types offacilities 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 of Healthcare 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 offacilities for lung volume reduction surgery published in the January through March 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 (January through March 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, 2006, we issued our decision memorandum on bariatric surgery procedures. EN25AP14.013</GPH> We determined that bariatric surgical procedures are reasonable and necessary for Medicare beneficiaries who have a body-mass index (BMI) greater than or equal to 35, have at least one co-morbidity related to obesity and have been previously unsuccessful 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 January through March 2014 period. This information is available at For questions or additional information, contact Kate Tillman, RN, MAS (410-786-9252). Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (January through March 2014) There were no FOG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the January through March 2014 quarter. This intormation is available on our website at For questions or additional infonnation, contact Stuart Caplan, RN, MAS (410-786-8564). Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 16:57 Apr 24, 2014 Geisinger Wyoming Valley Medical Center 1000 East Mountain Drive Wilkes Barre, PA 18711 Tulane University Hospital and Clinic 14 J 5 Tulane Avenue New Orleans, LA 70112 Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices [FR Doc. 2014–09288 Filed 4–24–14; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–1466–N] Medicare Program: Notice of Two Membership Appointments to the Advisory Panel on Hospital Outpatient Payment Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: This notice announces two new membership appointments to the Advisory Panel on Hospital Outpatient Payment (the Panel). The two new appointments to the Panel will each serve a 4-year period. The new members will have terms that begin on February 16, 2014 and continue through February 15, 2018. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their relative payment weights. The Panel also addresses and makes recommendations regarding supervision of hospital outpatient services. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system. FOR FURTHER INFORMATION CONTACT: For additional information on the Panel meeting dates, agenda topics, copy of the charter, as well as updates to the Panel’s activities, search our Internet Web site: https://www.cms.gov/ Regulations-and-Guidance/Guidance/ FACA/AdvisoryPanelonAmbulatory PaymentClassificationGroups.html. For other information regarding the Panel, contact Carol Schwartz, the Designated Federal Officer (DFO) at CMS, Center for Medicare, Hospital and Ambulatory Policy Group, Division of Outpatient Care, 7500 Security Boulevard, Mail Stop C4–05–17, Baltimore, MD 21244– 1850, phone (410) 786–3985. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: I. Background The Department of Health and Human Services (the Secretary) is required by section 1833(t)(9)(A) of the Social Security Act (the Act) (42 U.S.C. 1395l(t)(9)(A)) and section 222 of the VerDate Mar<15>2010 16:57 Apr 24, 2014 Jkt 232001 Public Health Service Act (PHS Act) (42 U.S.C. 217a) to consult with an expert outside advisory panel on the clinical integrity of the Ambulatory Payment Classification groups and relative payment weights, which are major elements of the Medicare Hospital Outpatient Prospective Payment System (OPPS), and the appropriate supervision level for hospital outpatient services. The Panel is governed by the provisions of the Federal Advisory Committee Act (FACA) (Pub. L. 92–463), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory panels. The Panel Charter provides that the Panel shall meet up to 3 times annually. We consider the technical advice provided by the Panel as we prepare the proposed and final rules to update the OPPS for the following calendar year. The Panel shall consist of a chair and up to 19 members who are full-time employees of hospitals, hospital systems, or other Medicare providers. The Secretary or a designee selects the Panel membership based upon either self-nominations or nominations submitted by Medicare providers and other interested organizations. New appointments are made in a manner that ensures a balanced membership under the FACA guidelines. The Panel presently consists of the following members and a Chair. • Edith Hambrick, M.D., J.D., Chair, CMS Medical Officer. • Karen Borman, M.D., FACS. • Kari S. Cornicelli, C.P.A., FHFMA. • Brian D. Kavanagh, M.D., MPH. • Scott Manaker, M.D., Ph.D. • John Marshall, CRA, RCC, CIRCC, RT(R), FAHRA. • Jim Nelson, M.B.A., C.P.A., FHFMA. • Leah Osbahr, M.A., MPH. • Jacqueline Phillips. • Traci Rabine. • Michael Rabovsky, M.D. • Marianna V. Spanaki-Varela, MD, Ph.D., M.B.A. • Gale Walker. • Kris Zimmer. II. Provisions of the Notice We published a notice in the Federal Register on November 1, 2013, entitled ‘‘Medicare Program; Solicitation of Five Nominations to the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel)’’ (78 FR 65660). The notice solicited nominations for five new members to fill the vacancies on the Panel beginning September 30, 2013. As a result of that notice, we are announcing two new members to the Panel. The Panel currently consists of 15 members. The two new Panel PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 22991 members appointments are for 4-year terms beginning on February 16, 2014. New Appointments to the Panel The two new members of the Panel with terms beginning on February 16, 2014 and continuing through February 15, 2018 are as follows: • Wendy Resnick, FHFMA. • Johnathan Pregler, M.D. III. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35). Dated: April 17, 2014. Marilyn Tavenner, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2014–09289 Filed 4–24–14; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0555] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for the tracking of medical devices. DATES: Submit either electronic or written comments on the collection of information by June 24, 2014. ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of SUMMARY: E:\FR\FM\25APN1.SGM 25APN1

Agencies

[Federal Register Volume 79, Number 80 (Friday, April 25, 2014)]
[Notices]
[Pages 22976-22991]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09288]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9085-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--January Through March 2014

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

ACTION: Notice.

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SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from January through March 2014, relating 
to the Medicare and

[[Page 22977]]

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.
[GRAPHIC] [TIFF OMITTED] TN25AP14.000

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 http://www.cms.gov/manuals.

    Authority: (Catalog of Federal Domestic Assistance Program No. 
93.773, Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714, 
Medical Assistance Program)

    Dated: April 16, 2014.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.

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[FR Doc. 2014-09288 Filed 4-24-14; 8:45 am]
BILLING CODE 4120-01-P