Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2016, 51901-51914 [2016-18546]

Download as PDF 51901 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices marketing rights to a generic carisoprodol product that was recently approved by the FDA. Once it begins marketing generic carisoprodol, Mylan likely would have been the third supplier of generic carisoprodol tablets. Mylan is one of a limited number of suppliers capable of entering the United States market in the near future. II. Entry Entry into the three relevant markets would not be timely, likely, or sufficient in magnitude, character, and scope to deter or counteract the anticompetitive effects of the proposed acquisition. The combination of drug development times and regulatory requirements, including approval by the United States Food and Drug Administration (‘‘FDA’’), is costly and lengthy. mstockstill on DSK3G9T082PROD with NOTICES III. Effects The proposed acquisition likely would cause significant anticompetitive harm to consumers by eliminating competition between Mylan and Meda in the markets for 400 mg and 600 mg generic felbamate tablets. Market participants characterize generic felbamate tablets as commodity products, and prices are inversely correlated with the number of competitors in each market. As the number of suppliers offering a therapeutically equivalent drug increases, the price for that drug generally decreases due to the direct competition between the existing suppliers and each additional supplier. The proposed acquisition would combine two of three companies offering the 400 mg and 600 mg strengths of generic felbamate tablets, likely leading consumers to pay higher prices. In addition, the proposed acquisition likely would cause significant anticompetitive harm to consumers by eliminating future competition that would otherwise have occurred in the 250 mg generic carisoprodol market if Mylan and Meda remained independent. The evidence shows that anticompetitive effects are likely to result from the proposed acquisition due to the elimination of an additional independent entrant in the market for 250 mg generic carisoprodol. Customers expect that the price of this pharmaceutical product will decrease with new entry by Mylan. Thus, absent a remedy, the proposed acquisition will likely cause U.S. consumers to pay significantly higher prices for 250 mg generic carisoprodol tablets. IV. The Consent Agreement The proposed Consent Agreement remedies the competitive concerns raised by the acquisition in the markets at issue by requiring Mylan to divest all its rights and assets relating to 400 mg and 600 mg generic felbamate tablets to Alvogen. Founded in 2009, Alvogen is an international pharmaceutical company with commercial operations in thirty-four countries. In addition, the proposed Consent Agreement requires Mylan to return its rights to market generic carisoprodol tablets in the United States to Indicus, the abbreviated new drug application owner for this product. The Commission’s goal in evaluating possible purchasers of divested assets is to maintain the competitive environment that existed prior to the proposed acquisition. If the Commission determines that Alvogen is not an acceptable acquirer, or that the manner of the divestitures is not acceptable, the proposed Order requires Mylan to unwind the sale of rights to Alvogen and then divest the products to a Commission-approved acquirer within six months of the date the Order becomes final. The proposed Order further allows the Commission to appoint a trustee in the event the parties fail to divest the products as required. The proposed Consent Agreement and Order contain several provisions to help ensure that the divestitures are successful. The proposed Order requires that Mylan transfer its manufacturing technology for felbamate to Alvogen and provide transitional services to assist Alvogen in establishing its manufacturing capabilities and securing all of the necessary FDA approvals. The transitional services include technical assistance to manufacture the product in substantially the same manner and quality employed or achieved by Mylan, and advice and training from knowledgeable employees of Mylan. In addition, Mylan must supply Alvogen with 400 mg and 600 mg generic felbamate tablets until Alvogen is able to manufacture generic felbamate successfully in commercial quantities. To remedy competitive concerns raised by the acquisition in the market for generic 250 mg carisoprodol tablets, the proposed Order requires Mylan to terminate its agreement with Indicus that gives Mylan the exclusive right to market and sell in the United States all strengths of carisoprodol tablets manufactured by Indicus. Indicus has existing relationships with suppliers of generic drugs that it can and expects to use to replace Mylan as its marketing partner for its carisoprodol products. The purpose of this analysis is to facilitate public comment on the proposed Consent Agreement, and it is not intended to constitute an official interpretation of the proposed Order or to modify its terms in any way. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2016–18563 Filed 8–4–16; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9098–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—April Through June 2016 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 April through June 2016, 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. SUMMARY: Addenda I II III IV V Contact CMS Manual Instructions ....................................................................................................... Regulation Documents Published in the Federal Register .................................................. CMS Rulings ......................................................................................................................... Medicare National Coverage Determinations ...................................................................... FDA-Approved Category B IDEs .......................................................................................... VerDate Sep<11>2014 17:42 Aug 04, 2016 Jkt 238001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Ismael Torres ..................... Terri Plumb ......................... Tiffany Lafferty ................... Wanda Belle, MPA ............. John Manlove ..................... E:\FR\FM\05AUN1.SGM 05AUN1 Phone number (410) (410) (410) (410) (410) 786–1864 786–4481 786–7548 786–7491 786–6877 51902 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices Addenda Contact 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 ................................................................................................................... Mitch Bryman ..................... Sarah Fulton, MHS ............ Sarah Fulton, MHS ............ JoAnna Baldwin, MS .......... JoAnna Baldwin, MS .......... Stuart Caplan, RN, MAS .... Linda Gousis, JD ................ Sarah Fulton, MHS ............ Sarah Fulton, MHS ............ Stuart Caplan, RN, MAS .... Annette Brewer .................. SUPPLEMENTARY INFORMATION: I. Background mstockstill on DSK3G9T082PROD 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 VerDate Sep<11>2014 17:42 Aug 04, 2016 Jkt 238001 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 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 00063 Fmt 4703 Sfmt 4703 Phone number (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) 786–5258 786–2749 786–2749 786–7205 786–7205 786–8564 786–8616 786–2749 786–2749 786–8564 786–6580 accessibility. In addition, many of the 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: July 27, 2016. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–P E:\FR\FM\05AUN1.SGM 05AUN1 mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 Jkt 238001 PO 00000 Frm 00064 Fmt 4703 Addendum 1: Medicare and Medicaid Manual Instructions (April through June 2016) 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 instmctions, 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\05AUN1.SGM 05AUN1 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 tlris nile and are still active paper-based manuals. The remaining paper-based manuals are for reference pmposes only. If you notice policy contained in the paper-based manuals that was not transferred to the 10M, send a message via the CMS Feedback tool. Those wishing to subscribe to old versions of CMS manuals should contact the National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-6050). You can download copies of the listed material free of charge at: https://cms.gov/manuals. How to Review Transmittals or Program Memoranda Those wishing to review transmittals and program memoranda can access this information at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. This information is available at https://www.gpo.gov/libraries/ In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most federal government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing entitled Medicare and Medicaid Manual Instructions. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the manual for Medicare Internet Only Manual Publication 100-04 Chapter 26- Completing and Processing Form CMS-1500 Data Set (CMS-Pub. 100-04) Transmittal No. 3490. Addendum I lists a unique CMS transmittal number for each instmction in our manuals or program memoranda and its subject number. A transmittal may consist of a single or mtutiple instmction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manual. For the purposes of this quarterly notice, we list only the specific updates to the list of manual instmctions that have occurred in the 3-month period. This information is available on our website at www.cms.gov/Manuals. Transmittal Number 99 100 222 Manual/Subject/Publication Number Medicare General Iilfomtion (CMS-Puh 100-01) Medicare Fee-for-Service Change Request Correction and Rescind Process Medicare fee-for-Service Change Request Correction and Rescind Process Change Management Process (Electronic Change Information Management Portal Medicare Benefit Policy (CMS-Pub. 100-02) Revisions to Private Contracting/Opt-Out Manual Sections Due to the Mt:dicart: Access and CHIP Reauthorization Act of 2015 (MACRA) Nonparticipating Physicians or Practitioners Who Opt-Out of Medicare Physicians or Practitioners Who Choose to Opt-Out of Medicare Opt-Out Relationship to Noncovered Services Maintaining Infonnation on Opt-Out Physicians Informing Medicare Managed Care Plans of the Identity of the Opt-Out Physicians or Practitioners Emergency and Urgent Care Situations Mandatory Claims Submission Cancellation of Opt-Out I I Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 17:42 Aug 04, 2016 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: August 3, 2015 (80 FR 45980) November 13, 2015 (80 FR 70218), February 4, 2016 (81 FR 6009) and May 9, 2016 (81 FR 28072). 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. 51903 EN05AU16.026</GPH> mstockstill on DSK3G9T082PROD with NOTICES 51904 VerDate Sep<11>2014 224 Medicare National Coverage Detei'lliinidiori (CMS~PU.b~ 100~03) Jkt 238001 191 192 193 PO 00000 Stem Cell Transplantation for .\1ultiple Myeloma, Myelofibrosis, Sickle Cell Disease, and Myelodysplastic Syndromes Percutaneous Left Atrial Appendage Closure (LAAC) Stem Cell Transplantation for .\1ultiple Myeloma, Myelofibrosis, Sickle Cell Disease, and Myelodysplastic Syndromes Stem Cell Transplantation9Formerly 110.8.1)(Various Effective Dates Below) 3504 :Medicare Clllin"l! ProcessiDg(CMS-PU.b.l00-04) Frm 00065 3490 3491 Fmt 4703 3492 3493 Sfmt 4725 3494 E:\FR\FM\05AUN1.SGM 3495 3496 3497 3498 3499 05AUN1 3500 3501 3502 EN05AU16.027</GPH> 3503 Medicare Internet Only Manual Publication 100-04 Chapter 26- Completing and Processing Form CMS-1500 Data Set Paymt:nt for Purchast:d Durablt: Mt:dical Equipmt:nt, Prosthdics, Orthotics, and Supplies (DMEPOS) Furnished to Medicare Beneficiaries Residing Outside the U.S. -Expatriate Beneficiaries Issued to a specific audience. not posted to Intemet/Intranet due to Confidentiality ofTnstruction Payment Change for Group 3 Complex Rehabilitative Power Wheelchair Accessories and Scat and Back Cushions under Section 2 of the Patient Access and Medicare Protection Act (PAMPA) Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity Instruction Indian Health Services (IHS) Hospital Payment Rates for Calendar Year 2016 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issut:d to a spt:cific audit:nct:, not postt:d to Inlt:mt:i/Intrant:t dut: to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP): Additional Instructions for the Implementation of Round 2 Recompete of the DMEPOS CBP and National Mail Order (NMO) Recompete Payment of a Part of a DMEPOS Item Payment for Capped Rental Items Payment for Inexpensive or Routinely Purchased Items Payment for Repair and Replacement of Beneficiary-Owned Equipment Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Making Principal Diagnosis Codes Mandatorv for Notice of Election (NOE) 3505 3506 3507 3508 3509 3510 to be Accepted Completing the Uniform (Institutional Provider) Bill (Form CMS 1450) for Hospice Election Service Intensity Add-on (SIA) Payments Frequency of Billing and Same Day Billing Billing ofVaccine Services on Hospice Claims Payer Only Codes Utilized by Medicare Hospice Claims for Vaccine Services Billing Requirements Claims Submitted to MACs Using Institutional Fom1ats Payment for Pneumococcal Pneumonia Virus, Influenza Virus, and Hepatitis B Virus Vaccines and Their Administration on Institutional Claims Institutional Claims Submitted by Home Health Agencies and Hospice Payment Procedures for Renal Dialysis Facilities (RDF) Revision of the Method to Calculate the Length of Stay (LOS) Edit for Continuous Invasive Mechanical Ventilation for Greater than 96 Consecutive Hours Medicare Code Editor (MCE) Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction JW Modifier: Dmg amount discarded/not administered to any patient Discarded Drugs and Biologicals Stem Cell Transplantation for Multiple Myeloma, Myelofibrosis, Sickle Cell Disease, and Myclodysplastic Syndromes St= Cdl Transplantation Billing for Stem Cell Transplantation Billing tor Autologous Stem Cell Transplants Billing for Allogeneic Stem Cell Transplants Stem Cell Transplantation Updates to Pub. 100-04, Chapters 1 and 16 to Correct Remittance Advice Messages Claims Processing Instructions for Payment Jurisdiction An AlB MAC (B) Receives a Claim for Services that are in Another AlB MAC (B)'s Payment Jurisdiction An AlB MAC (B) Receives a Claim for Services that are in a DME Payment Jurisdiction A DME MAC Receives a Claim for Services that are in an AlB MAC (B) Payment Jurisdiction An AlB MAC (B) Receives a Claim for an RRB Beneficiary An AlB MAC (B) or DME MAC Receives a Claim for a UMWA Beneficiary A DME MAC receives a Paper Claim with Items or Services that are in Another DME MAC's Payment Jurisdiction Deported Medicare Beneficiaries Processing Claims for Services ofParticipating Physicians or Suppliers Charges for Missed Appointlllents Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 17:42 Aug 04, 2016 223 Early Termination of Opt-Out Appeal Claims Denial Notices to Opt-Ont Physicians and Practitioners Clarification of Inpatient Psychiatric Facilities (IPF) Requirements for Certification, Recertification and Delayed/Lapsed Certification and Recertification Update to Pub. 100-02, Chapter 11 End-Stage Renal Disease (ESRD) for Calendar Year (CY) 2016 mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 Jkt 238001 PO 00000 3512 Frm 00066 3513 3514 Fmt 4703 3515 3516 3517 Sfmt 4725 3518 3519 E:\FR\FM\05AUN1.SGM 3520 3521 05AUN1 3522 3523 3524 3528 3529 1510 3531 3532 3533 3534 3535 3536 3537 3538 3539 3540 3541 3542 3543 1544 3545 17.2 3525 3526 1527 Common Edits and Enhancements Modules (CEM) Code Set Update Issued to a specitlc audience, not posted to IntemeVIntranet due to Confidentiality of Instruction Claim Status Category and Claim Status Codes 1 Jpdate 3546 1547 3548 Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - July CY 2016 Update Instructions for Downloading the Medicare ZIP Code File for October 2016 .TW Modifier: Drug amount discarded/not administered to any patient Discarded Drugs and Biologicals July 2016 Update of the Ambulatory Surgical Center (ASC) Payment System Annual Update of the Intemational Classification of Diseases, Tenth Revision, Clinical Moditlcation (IClJ-10-CM) Payments to Home Health Agencies That Do Not Submit Required Quality Data Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiality of Instruction Payment Change for Group 3 Complex Rehabilitative Power Wheelchairs Accessories and Seat and Back Cushions under Section 2 ofthe Patient Access and Medicare Protection Act (PAMPA) Issued to a specific audience, not posted to IntemeV Intranet due to Sensitivity Instruction Corrections to Chapter 1 of the Medicare Claims Processing 'v!anual Claims Submitted for Items or Services Fumished to Medicare Beneficiaries in State or Local Custody Under a Penal Authority Application to Special Claim Types Payer Ouly Codes Utilized bv Medicare JW Modifier: Drug amount discarded/not administered to any patient Discarded Drugs and Biologicals Issued to a specific audience, not posted to hitemeVhitranet due to Confidentiality of Instruction Billing ofVaccine Services on Hospice Claims Hospice Claims for Vaccine Services Rilling Requirements Claims Submitted to MACs Using Institutional Formats Payment for Pneumococcal Pneumonia Virus, Influenza Virus, and Hepatitis B Virus Vaccines and Their Administration on Institutional Claims Institutional Claims Submitted by Home Health Agencies and Hospices Payment Procedures for Renal Dialysis Facilities (RDF) Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiality of Instruction Issued to a specitlc audience, not posted to hitemeVhitranet due to Confidentiality of Instruction New Physician Specialty Code for Dentist Physician Specialty Codes Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiality of Instruction October Quarterly Update to 2016 Annual Update ofHCPCS Codes Used tor Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement New Physician Specialty Code for Dentist Issued to a specific audience, not posted to IntemeVIntranet due to Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 17:42 Aug 04, 2016 3511 Coding That Results from Processing Noncovered Charges Handling Incomplete or Invalid Claims AlB MAC (B) Data Element Requirements Conditional Data Element Requirements for AlB MACs and DMEMACs AIR MAC (R) Specific Requirements for Certain Specialties/Services General Explanation of Payment Assignment Required Physician Notification of Denials Reasons for Denial - Physician Office Laboratories Out-of-Compliance Changes to the Fiscal Intermediary Shared System (FISS) Inpatient Provider Specific File (PSF) for Low-Volume Hospital Payment Adjustment Factor and New Inpatient Prospective Payment System (IPPS) Pricer Output Field for Islet Isolation Add-on Payment A/Provider Specific File Procedure for Medicare Contractors to Perform and Record Outlier Reconciliation Adjustments Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiality of h1struction Percutaneous Left Atrial Appendage Closure (LAAC) Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to IntemeVIntranet due to Sensitivity Instruction Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes- July 2016 Update Corrections to Chapter 1 of the Medicare Claims Processing 'v!anual Claims Submitted for Items or Services Fumished to Medicare Beneficiaries in State or Local Custody Under a Penal Authority Application to Special Claim Type Payer Only Codes Utilized by Medicare 2016 Durable Medical Equipment Prosthetics, Orthotics, and Supplies Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction List Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Update to Intemet-Ouly-Manual Publication 100-04, Chapter 18, Section 30.6 Screening Pap Smears: Diagnoses Codes July 2016 Update ofthe Hospital Outpatient Prospective Payment System (OPPS) Billing Instructions for IMRT Planning and Delivery July 2016 Integrated Outpatient Code Editor (IIOCE) Specifications Version 51905 EN05AU16.028</GPH> mstockstill on DSK3G9T082PROD with NOTICES 51906 VerDate Sep<11>2014 3549 Jkt 238001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4725 E:\FR\FM\05AUN1.SGM 3552 05AUN1 3553 3554 3555 117 118 266 267 268 269 154 155 156 157 643 644 645 646 647 648 649 650 651 652 EN05AU16.029</GPH> Medicare Secondary Payer (CMS-Pub. 100-05) None Remote Identity Prootlng (Rll)P) and Multi-Factor Authentication (MFA) for Electronic Correspondence Referral System (ECRS) Web Users Individuals Not Subject to the Limitation on Medicare Secondary Payment (MSP) Medicare Fillllllcial Mamtgement (CMS-Pub. 100-06) Notice of"\few Interest Rate for Medicare Overpayments and Underpayments -3rd Qtr Notification for FY 20 16 Notice of \few Interest Rate for Medicare Overpayments and Underpayments -3rd Qtr Notification for FY 2016 New Physician Specialty Code for Dentist New Physician Specialty Code for Dentist Physician/Limited License Physician Specialty Codes Meilieare State Operation Mimual (CMS-Pub. 100-07) Revisions to the State Operations Manual (SOM)- Chapter 2 Fxit Conference A Introductory Remarks B Ground Rules C Presentation of Finding D Closure Limitations on Technical Assistance Afforded by Surveyors Revisions to the State Operations Manual (SOM) -Chapter 5 Survey Exit Conference and Report to the Provider/Supplier Task 7: Exit Conference Post-Survey Certification Actions for Nursing Homes Survey Protocol for Long Tenn Care Facilities- Pmt 1/IV Deficiency Categorization/E. Psychosocial Outcome Severity Guide Revisions to the State Operations Manual (SOM) -Appendix PP- Guidance to Surveyors for Long Term Care Facilities Medleare.Prow-am.Intell)ity (CMS-Pub. 100-08) Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Inteniet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of h1struction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality ofTnstruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Medical Review of Skilled Nursing Facility Prospective Payment System (SNF PPS) Bills Issued to a specific audience, not posted to Intemet/Intranet due to I I I I Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 17:42 Aug 04, 2016 3550 3551 Confidentiality of Instruction Pub. 100-04, Chapter 29- Appeals of Claims Decisions Update: Revisions to Timeliness Requirements for Forwarding Misfiled Appeal Requests, Reconsideration Request Fonn, and Guidelines for Writing Appeals Correspondence Glossary CMS Decisions Subject to the Administrative Appeals Process Who May Appeal Steps in the Appeals Process: Overview Where to Appeal Conditions and Examples That May Establish Good Cause for Late Filing by Beneficiaries Amount in Controversy General Requirements Principles for Determining Amount in Controversy Parties to an Appeal How to Make and Revoke an Appointment Appeals of Claims Involving Excluded Providers, Physicians, or Other Suppliers Reading Levels General Information Filing a Request for Redetennination Time Limit for Filing a Request for Redetermination T11e Redetennination The Redetermination Decision Dismissals Medicare Redetermination Notice (For Partly or Fully Unfavorable Redeterminations Filing a Request for a Reconsideration Time Limit for Filing a Request for a Reconsideration Contractor Responsibilities -General QIC Jurisdictions Tracking Cases Requests for an AU Hearing New Waived Tests July Quarterly Update for 2016 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule July 2016 Update of the Hospital Outpatient Prospective Payment System (OPPS) New Condition Code for Reporting Home Health Episodes With No Skilled Visits Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) - October 2016 Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update FY 2017 mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 149 17:42 Aug 04, 2016 1641 1642 1643 Jkt 238001 1644 PO 00000 1645 1646 Frm 00068 1647 Fmt 4703 1648 1649 Sfmt 4725 1650 1651 E:\FR\FM\05AUN1.SGM 1652 05AUN1 1653 1654 1655 1656 1657 1658 1659 Instruction Issued to a specific audience, not posted to lnterneV Intranet due to Sensitivity Instruction .One.Tbne Notification (CMS-Pub. 100-20) Issued to a specific audience, not posted to InterneV Intranet to Sensitivity of Instruction Implementation of the Award for Jurisdiction A Durable Medical Equipment (DME) Medicare Administrative Contractor ('viAC) Workload Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of Instruction Reclassification of Certain Durable Medical Equipment HCPCS Codes Included in Competitive Bidding Programs (CBP) from the Inexpensive and Routinely Purchased Payment Category to the Capped Rental Payment Category Analysis of the Combined Common Edits/Enhancements Module (CCEM) 3rd Party Software Upgrade (Jaspersoft) reporting software for the Combined Common Edits/Enhancement Module (CCEM) Payment Change for Group 3 Complex Rehabilitative Power Wheelchairs Accessories and Seat and Back Cushions under Section 2 of the Patient Access and Medicare Protection Act (PAMPA) for Home Health Claims Issued to a specific audience, not posted to IntemeV Intranet to Sensitivity of Instruction Phase 2 of Updating the Fiscal Intermediary Shared System (FISS) to Make Payment for Drugs and Biologicals Services for Outpatient Prospective Payment System (OPPS) Providers Shared System Enhancement 2015: Archive/Remove Inactive Medicare Demonstration Projects National Provider Identifier Crosswalk System (NPICS) Retirement Analysis Only- Engage Shared Systems Maintainers and Medicare Administrative Contractors (MACs) in Meetings and Correspondence Related to the NPICS Retirement with the Stakeholders Analysis Only: To Obtain a Rough Onler of Magnitudt: (ROM) from Durablt: Medical Equipment Medicare Administrative Contractors (DME MACs), GDIT/VMS, the National Supplier Clearinghouse (NSC) and the Common Electronic Data Interchange (CEDI) Contractor to Develop and Implement a Process for DME MAC Provider Self-Service Internet Portal Authentication of Medicare Providers Using EDI Enrollment Data Elements New State Code for AZ, ID, NY, and WV System Changes to Implement Section 231 ofthe Consolidated Appropriations Act, 2016, Temporary Exception for Certain Severe Wound Discharges From Certain Long-Tenn Care Hospitals (LTCHs) Recurring calls with the Fiscal Intermediary Shared System (FISS) for any indepth discussions Issued to a specific audience, not posted to Inten1eV Intranet to Sensitivity of Instruction Issuing Continuing Compliance Letters to Specific Providers and Suppliers Coding Revisions to National Coverage Determinations Convert Assembler Code to COBOL or Best Coding Language to Improve Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices Confidentiality of Instruction Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to IntemeVIntranet due to 654 Confidentiality of Instruction ·Medicare Contractor Beneficiary and Provider Cbmmunicatiom (CMS·Pub. 100·09) I None Medicare Qrudity Improvement Orgaiiliatimi (CMS- Pub. 100-10) QIO Manual Chapter II - Hospital Payment Monitoring Program (HPMP) 25 QIO Manual Chapter 2- Eligibility 26 QIO Manual Chapter 12 "Communications, Outreach, and Program-related 27 Infonnation Activities" Medicare End Stae:e Renal Disease Network 011!aiiliations (CMS Pub 100-14) I None Medicaid Proe:ram Intce:rltv Disease ~etwork Ore:anizatiom (CMS Pub 100-15) None Medicare Managed Care (CMS-Pub.100-16) 121 Chapter 4, Benefits and Beneficiary Protections General Requirements Basic Rule Exceptions to Requirements forMA plans to Cover FFS Benefits Types of Benefits Hospice Coverage Uniformity Anti-Discrimination Review for Discrimination and Steering Confidentiality Multiple Plan Otlerings and Benefit Caps Payment for Investigational Device Exemption (IDE) Studies Return to Enrollee's Home Skilled Nursing Facility (SNF) Therapy Caps and Exceptions 122 Chapter 14, Contract Determinations and Appeals Medimre Bw;ine~S~~ Partners Svstems SecuritJr (CMS-Pub. 100-17) None Demomtrations (Cl\IS-Pub. 100-19) 142 Affordable Care Act Bundled Payments for Care Improvement InitiativeRecurring File Updates Models 2 and 4 July 2016 Updates 143 Implementing Payment Changes for I'CIITP (frontier Community Health Integration Project), Mandated by Section 123 ofMIPPA 2008 and as Amended by Section 3126 of the ACA of2010 (This CR Rescinds and Replaces CR8683) Issued to a specific audience, not posted to InterneV Intranet to 144 Confidentiality of Instruction Update to the Common Working File Edits for G9678- Oncology Care 145 Model Service 146 Oncology Care Model (OCM) Monthly Enhanced Oncology Services (MEOS) Payment Inmlementation Issued to a specific audience, not posted to IntemeV Intranet due to Sensitivity 147 Instruction 148 Issued to a specific audience, not posted to InterneV Intranet due to Sensitivity 653 51907 EN05AU16.030</GPH> mstockstill on DSK3G9T082PROD with NOTICES 51908 VerDate Sep<11>2014 1660 1662 1663 Jkt 238001 1664 PO 00000 1665 1666 1667 Frm 00069 1668 Fmt 4703 1669 Sfmt 4725 E:\FR\FM\05AUN1.SGM 05AUN1 EN05AU16.031</GPH> 1670 57 Addendum II: Regulation Documents Published in the Federal Register (April through June 2016) Regulations and Notices Regulations and notices are published in the daily Federal Register. To purchase individual copies or subscribe to the Federal Register, contact GPO at www.gpo.gov/fdsys. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number. The Federal Register is available as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) through the present date and can be accessed at https://www.gpoaccess.gov/fr/. The following website https://www.archives.gov/federal-register/ provides information on how to access electronic editions, printed editions, and reference copies. This information is available on our website at: https://www. ems. govI quarterlyprovidempdates/downloads/Re gs2Q16QPU.pdf For questions or additional information, contact Terri Plumb (410-786-4481). Addendum III: CMS Rulings (Aptil through June 2016) 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 !2..!±1Ldl..l.!.J!:!..!!~!!.!±.~l:..!L~c!±!ili!!!~ For questions or additional information, contact Tiffany Lafferty (410-786-7548). Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 17:42 Aug 04, 2016 1661 MCS System Maintainability and Sustainability, Analysis only. Shared Savings Program (SSP) Accountable Care Organization (ACO) QualifYing Stay Edits Issued to a specific audience, not posted to InterueV Intranet to Sensitivity of Instruction Issued to a specific audience, not posted to InterueV Intranet to Sensitivity of Instruction Issued to a specific audience, not posted to Internet/ Intranet to Confidentiality of Instruction Reporting Medicare Administrative Contractor (MAC) Provider Education Website Analytic Data to the Provider Customer Service Program Contractor Information Database (PCID) Coding Revisions to National Coverage Determinations (NCDs) Issued to a specific audience, not posted to InterueV Intranet to Sensitivity of Instruction Issued to a specific audience, not posted to InterueV Intranet to Sensitivity of Instruction National Provider Identifier Crosswalk System (NPICS) Retirement Analysis Only- Engagt: Shart:d Syslt:ms Maintaint:rs and Mt:dicart: Administratiw Contractors (MACs) in Meetings and Correspondence Related to the NPICS Retirement with the Stakeholders Guidance on Implementing System Edits for Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Shared System Enhancement 2014- Identification of Fiscal Intermediary Standard System (FISS) Obsolete Reports - Analysis Only Medicare Qualitv Reportine; Incentive P.roe;.ranJS (CMS- Pub. 100-22) Payments to Home Health Agencies That Do Not Submit Required Quality Data lnfonnation Security Acceptable Risk Safeguards (CMS-Pub. 100-25) I None mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 Jkt 238001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4725 Title E:\FR\FM\05AUN1.SGM 05AUN1 Percutaneous Left Atrial Appendage Closure (LAAC) Stem Cell Transplantation for Multiple Myeloma, Myelofibrosis, Sickle Cell Disease, and Myelodysplastic Syndromes number. For the purposes of this quarterly notice, we list only the specific updates to the Category BIDEs as of the ending date of the period covered by this notice and a contact person for questions or additional information. For questions or additional information, contact John Manlove (410-7866877). Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved investigational device exemption (IDE). Category A refers to experimental IDEs, and Category B refers to non-experimental IDEs. To obtain more infonnation about the classes or categories, please refer to the notice published in the April21, 1997 Federal Register (62 FR 19328). IDE Gl60051 Gl60053 Gl60058 0160056 Gl60054 Gl60061 Gl60065 NCDM Section Transmittal Number Issue Date Effective Date NCD 20.34 Rl92 05/06/2016 02/08/2016 Gl60063 Gl60064 Gl60074 0160067 01127/2016 Gl40102 Gl60066 Gl60071 Gl60072 NCD ll0.23 Rl91 04/29/2016 Addendum V: FDA-A11proved Category B Investigational Device Exemptions (IDEs) (April through June 2016) 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 Gl60073 Gl60077 Gl60078 Gl60081 BB16430 Gl20246 Gl50199 Gl60082 Gl60084 G040175 Device Brainsway Deep TMS System utilizing the H2-coil Closing the Loop on Tremor: A Responsive Deep Brain Stimulator for the Treatment of Essential Tremor True Beam, True Beam STx, Edge Allurion Elipse Device Repetitive Transcanial Magnetic Stimulation (rTMS) for Obsessive-Compulsive Disorder Spatz3 Adjustable Balloon System iNod Biopsy Needle, iNod Ultrasound Catheter, iNod Ultrasound Imaging System, iNod Motor Drive Unit, iNod Sled HEMOBLAST Bellows Hemostatic Agent Sight Sciences VISCO 360 Viscosurgical System MAD IT S-ICD Clinical Study NeoChord Artificial Chordae Delivery System, Model DSlOOO ThermoCool SmartTouch SF Catheter Embosphere Microspheres NeuroBlate System Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP) trial MED-EL Synchrony cochlear implant with the FLEX28 electrode array Orbera Intragastric Balloon SJM MRI Diagnostic Imaging Registry \VIRION Embolic Protection System (EPS) DryThaw-MTS1-C Exablate Transcranial MRGFUS Thalmotomy Treatment Model SC9 Posterior Chamber Intraocular Lens DBS Leads, Activa PC Stimulator, DBS Extension Revanesse Ultra+ (with lidocaine) Relay Thoracic Stend Graft with Transport Delivery System Sta11 Date 04113/2016 04/14/2016 04/14/2016 04/lS/2016 04/20/2016 04/20/2016 04/2112016 04/22/2016 04/22/2016 04/26/2016 04/27/2016 04/27/2016 04/27/2016 04/29/2016 04/29/2016 04/29/2016 05/04/2016 05/05/2016 05/06/2016 05/08/2016 05113/2016 05113/2016 05/14/2016 05/17/2016 05/20/2016 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 17:42 Aug 04, 2016 Addendum IV: Medicare National Coverage Determinations (April through June 2016) Addendum IV includes completed national coverage determinations (NCDs), or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions arc 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 decision. An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII of the Act), but does not include a 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. Information on completed decisions as well as pending decisions has also been posted on the CMS website. For the purposes of tlris quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available at: www.cms.gov/medicarecoverage-database/. For questions or additional information, contact Wanda Belle, MPA (410-786-7491). 51909 EN05AU16.032</GPH> mstockstill on DSK3G9T082PROD with NOTICES 51910 VerDate Sep<11>2014 IDE Start Date 05/25/2016 05/25/2016 05/25/2016 05/26/2016 06/01/2016 Frm 00071 06/01/2016 06/01/2016 06/02/2016 06/03/2016 06/14/2016 06/15/2016 06/22/2016 06/22/2016 06/22/2016 06/22/2016 06/23/2016 Sfmt 4725 Addendum VI: Approval Numbers for Collections of Information (April through June 2016) 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 information collections. This information is available at www.reginfo.gov/public/do/PRAMain. For questions or additional information, contact Mitch Bryman (410-786-5258). E:\FR\FM\05AUN1.SGM Fmt 4703 Gl60113 05AUN1 EN05AU16.033</GPH> 06/24/2016 Addendum VII: Medicare-Approved Carotid Stent Facilities, (April through June 2016) 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: https://www. ems. gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Facility Provider Effective Number Date The following facilities are new listings for this quarter. South Georgia Medical Center 1306896253 04/12/2016 2501 N. Patterson Street Valdosta, GA 31602 Baptist Memorial Hospital- North Mississippi 250034 04/12/2016 (Baptist North Mississippi) 2301 South Lamar Boulevard Oxford, MS 38655 Aurora Medical Center - Oshkosh 060112 04/21/2016 855 North Westhaven Drive Oshkosh, WI 54904 The following facility has editorial changes (in bold). 23-0066 12/21/2005 FROM: Mercy General Health Partners TO: Mercy Health Partners 1500 East Sherman Boulevard Muskegon, MI49444 State GA MS WI MI Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (April through June 2016) Addendum VIII includes a list of the American College of Cardiology's National Cardiovascular Data Registry Sites. We cover implantable cardioverter defibrillators (ICDs) for certain clinical indications, as long as information about the procedures is reported to a central registry. Detailed descriptions of the covered indications are available in the NCD. In January 2005, CMS established the lCD 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) TCD Registry satisfies the data reporting requirements in the NCD. Hospitals needed to transition to the ACC-NCDR lCD 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 lCD procedure. Details of the clinical indications that arc covered by Medicare Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices Jkt 238001 Gl60093 Gl60094 Gl60049 Gl60001 Gl60107 Gl60105 Gl60109 Gl60111 Gl50137 Gl60060 Gl60110 PO 00000 17:42 Aug 04, 2016 Gl60087 Gl50241 Gl60013 Gl60089 Gl60092 Device for treatment of thoracic aortic aneurysms. Aspen System Ellipse ICD and Durata and Optisure high voltage lead system Bio Ventrix Revivent TC System NovoTTF-lOOM System Bioness StimRouter Neuromodulation System, StimRouter Lead Kit, StimRouter Surgical Tool Kit, StimRouter Clinician Kit, StimRouter User Kit OVT TSolution One TK.A. EnligHTN Renal Denervation System Covera Vascular Covered Stent ZiftLift System therascreen BRAF V600E RGQ PCR Kit Covera Vascular Covered Stent MET Exon 14 Skipping Test JUVEDERM VOLUMA XC ClariCore Biopsy System TIVUS System, Multidirectional TIVUS Catheter (also referred as TTv1 JS Catheter), TTV1 TS Console SAFE - PCI in STEMI for Seniors mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 and their respective data reporting requirements are available in the Medicare NCD Manual, which is on the CMS website at Jkt 238001 PO 00000 Frm 00072 Fmt 4703 Facility I City Sfmt 4725 E:\FR\FM\05AUN1.SGM 05AUN1 The following facilities are new listings for this quarter. Memorial Hermann Sugar Land Sugar Land Tennova-North Knoxville Medical Center Powell Wichita Ambulatory Surgery Center Wichita Alexandria Alexandria Ambulatory Surgery Center Baytown Ambulatory Surgery Center Baytown Watertown Medical Center, LLC Watertown Nason Medical Center, LLC Roaring Spring Trios Health Kennewick Memorial Hermann Pearland Pearland North Metro Medical Center Jacksonville Ohio Valley General Hospital McKees Rocks HHCASC, LLC St. Louis St. Bernard Parish Hospital Chalmette Palms of Pasadena Hospital St. Petersburg Melrose-Wakefield Hospital Melrose Saint Anne's Hospital Fall River United Hospital System Kenosha Watsonville Connnunity Hospital Watsonville Bristol Regional Medical Center Bristol UPMC McKeesport McKeesport Lafayette General Southwest Lafayette State TX TN KS LA TX WI PA WA TX AZ PA MO LA FL MA MA WI CA TN PA LA Addendum IX: Active CMS Coverage-Related Guidance Documents Addendum XI: National Oncologic PET Registry (NOPR) (April through June 2016) Addendum XI includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission tomography (PET) scans for particular oncologic indications when they are performed in a facility that participates in the NOPR. In January 2005, we issued our decision memorandum on positron emission tomography (PET) scans, which stated that CMS would cover PET scans for particular oncologic indications, as long as they were performed in the context of a clinical study. We have since recognized the National Oncologic PET Registry as one of these clinical studies. Therefore, in order for a beneficiary to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the registry. There were no additions, deletions, or editorial changes to the listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the 3-month period. This information is available at https://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 17:42 Aug 04, 2016 A provider can use either of two mechanisms to satisfy the data reporting requirement. Patients may be emolled either in an Investigational Device Exemption trial studying ICDs as identified by the FDA or in the ACC-NCDR lCD registry. Therefore, for a beneficiary to receive a Medicare-covered lCD implantation for primary prevention, the beneficiary must receive the scan in a facility that participates in the ACC-NCDR lCD registry. The entire list of facilities that participate in the ACC-NCDR lCD registry can be found at www.ncdr.com/webncdr/common For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. 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: www.ncdr.com/webncdr/common. For questions or additional information, contact Sarah Fulton, MHS (410 786 27 49). (April through June 2016) CMS issued a guidance document on November 20, 2014 titled "Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development Document". Although CMS has several policy vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS's implementation of coverage with evidence development (CED) through the national coverage determination process. The document is available at https://www. ems. gov/medicare-coverage-database/details/medicarecoverage-document-details.aspx?MCDld=27. There are no additional Active CMS Coverage-Related Guidance Documents for the 3-month period. For questions or additional information, contact JoAnna Baldwin, MS (410-786-7205). Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (April through June 2016) There were no special one-time notices regarding national coverage provisions published in the 3-month period. This information is available at www.cms.hhs.gov/coverage. For questions or additional information, contact JoAnna Baldwin, MS (410-786 7205). 51911 EN05AU16.034</GPH> mstockstill on DSK3G9T082PROD with NOTICES 51912 VerDate Sep<11>2014 Jkt 238001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4725 Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (April through June 2016) 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 1, 2003, we issued our decision memorandum on V ADs for the clinical indication of destination therapy. We determined that VADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. We are providing only the specific updates to the list of Medicareapproved facilities that meet our standards that have occurred in the 3-month period. This information is available at https://www. ems. gov/MedicareApprovedF acilitie/VAD/list. asp#TopOfPage. For questions or additional information, contact Linda Gousis, JD, (410-786-8616). E:\FR\FM\05AUN1.SGM Date Approved Provider Number The following faciHiies are new Jisiings for ibis quarier. Saint Cloud Hospital 240036 04113/2016 1406 Sixth Avenue North Facility 05AUN1 Saint Cloud. MN 56303 Lubbock County Hospital District 450686 06/17/2016 602 Indiana Avenue Lubbock, TX 79415 Fresno Community Hospital and 1104906569 11105/2014 'v!edical Center 2823 Fresno Street Fresno, CA 93721 The followinll; facility is beffiv removed as ofthis quarter. Albany Medical Center Hospital 111/06/2013 133-0013 43 New Scotland Avenue Albany, NY State MN TX CA INY Addendum XIII: Lung Volume Reduction Surgery (LVRS) (April through June 2016) Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (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 L VRS; and • Medicare approved for lung transplants. Only the first two types arc in the list. There were no updates to the listing of facilities for lung volume reduction surgery published in the 3-month period. This infonuation is available at www. ems. gov/MedicareApprovedF acilitie/LVRS/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-27 49). Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (April through June 2016) 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. 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: (1) 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 (ESCOE) (program standards and requirements in effect on February 15, 2006). Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 17:42 Aug 04, 2016 EN05AU16.035</GPH> For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 Jkt 238001 PO 00000 Frm 00074 Fmt 4703 Sfmt 9990 E:\FR\FM\05AUN1.SGM Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (April through June 2016) There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the 3-month period. This information is available on our website at www.cms.gov/MedicareApprovedFacilitie/PETDT!list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). 05AUN1 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 17:42 Aug 04, 2016 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 3-month period. This information is available at www. ems. gov/MedicareApprovedF acilitie/B SF/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). 51913 EN05AU16.036</GPH> 51914 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices [FR Doc. 2016–18546 Filed 8–4–16; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10243] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. AGENCY: 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 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 September 6, 2016. 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: mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:42 Aug 04, 2016 Jkt 238001 1. Access CMS’ Web site address at https://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 publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: Testing Experience and Functional Tools: Functional Assessment Standardized Items (FASI) Based on the CARE Tool; Use: In 2012, CMS funded a project entitled, Technical Assistance to States for Testing Experience and Functional Tools (TEFT) Grants. One component of this demonstration is to amend and test the reliability of a setting-agnostic, interoperable set of data elements, called ‘‘items,’’ that can support standardized assessment of individuals across the continuum of care. Items that were created for use in post-acute care settings using the Continuity Assessment Record and Evaluation (CARE) tool have been adopted, modified, or supplemented for use in community-based long-term services and supports (CB–LTSS) programs. This project will test the reliability and validity of the function-related assessment items, now referred to as Functional Assessment Standardized Items (FASI), when applied in community settings, and in various PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 populations: Elders (65 years and older); younger adults (18–64) with physical disabilities; and adults of any age with intellectual or developmental disabilities, with severe mental illness, or with traumatic brain injury. Individual-level data will be collected two times using the TEFT FASI Item Set. The first data collection effort will collect data that can be analyzed to evaluate the reliability and validity of the FASI items when used with the five waiver populations. Assessors will conduct functional assessments in client homes using the TEFT FASI Item Set. Changes may be recommended to individual TEFT FASI items, to be made prior to releasing the TEFT FASI items for use by the states. The FASI Field Test Report will be released to the public. The second data collection will be conducted by the states to demonstrate their use of the FASI data elements. The assessment data could be used by the states for multiple purposes. They may use the standardized items to determine individual eligibility for state programs, or to help determine levels of care within which people can receive services, or other purposes. In the second round of data collection, states will demonstrate their proposed uses, manage their FASI data collection and conduct their own analysis, to the extent they propose to do such tasks. The states have been funded under the demonstration grant to conduct the round 2 data collection and analysis. These states will submit reports to CMS describing their experience in the Round 2 data collection, including the items they collected, how they planned to use the data, and the types of challenges and successes they encountered in doing so. The reports may be used by CMS in their evaluation of the TEFT grants. Subsequent to the publication of our 60-day Federal Register notice (May 2, 2016; 81 FR 26235), we have made several minor modifications to the form. The changes are intended to further protect participant identification and improve the response efficiency by removing several checkboxes that we were using for item screening purposes. The instructions were revised accordingly. The revisions have no impact on our 60-day burden estimates. Form Number: CMS–10243 (OMB control number: 0938–1037); Frequency: On occasion; Affected Public: Individuals and Households; Number of Respondents: 5,650; Total Annual Responses: 5,650; Total Annual Hours: 2,825. (For policy questions regarding this collection contact Allison Weaver at 410–786–4924.) E:\FR\FM\05AUN1.SGM 05AUN1

Agencies

[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)]
[Notices]
[Pages 51901-51914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18546]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9098-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--April Through June 2016

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 April through June 2016, 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 number
----------------------------------------------------------------------------------------------------------------
I CMS Manual Instructions.............  Ismael Torres...........................  (410) 786-1864
II Regulation Documents Published in    Terri Plumb.............................  (410) 786-4481
 the Federal Register.
III CMS Rulings.......................  Tiffany Lafferty........................  (410) 786-7548
IV Medicare National Coverage           Wanda Belle, MPA........................  (410) 786-7491
 Determinations.
V FDA-Approved Category B IDEs........  John Manlove............................  (410) 786-6877

[[Page 51902]]

 
VI Collections of Information.........  Mitch Bryman............................  (410) 786-5258
VII Medicare-Approved Carotid Stent     Sarah Fulton, MHS.......................  (410) 786-2749
 Facilities.
VIII American College of Cardiology--   Sarah Fulton, MHS.......................  (410) 786-2749
 National Cardiovascular Data Registry
 Sites.
IX Medicare's Active Coverage-Related   JoAnna Baldwin, MS......................  (410) 786-7205
 Guidance Documents.
X One-Time Notices Regarding National   JoAnna Baldwin, MS......................  (410) 786-7205
 Coverage Provisions.
XI National Oncologic Positron          Stuart Caplan, RN, MAS..................  (410) 786-8564
 Emission Tomography Registry Sites.
XII Medicare-Approved Ventricular       Linda Gousis, JD........................  (410) 786-8616
 Assist Device (Destination Therapy)
 Facilities.
XIII Medicare-Approved Lung Volume      Sarah Fulton, MHS.......................  (410) 786-2749
 Reduction Surgery Facilities.
XIV Medicare-Approved Bariatric         Sarah Fulton, MHS.......................  (410) 786-2749
 Surgery Facilities.
XV Fluorodeoxyglucose Positron          Stuart Caplan, RN, MAS..................  (410) 786-8564
 Emission Tomography for Dementia
 Trials.
All Other Information.................  Annette Brewer..........................  (410) 786-6580
----------------------------------------------------------------------------------------------------------------


SUPPLEMENTARY INFORMATION: 

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 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: July 27, 2016.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P

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[FR Doc. 2016-18546 Filed 8-4-16; 8:45 am]
 BILLING CODE 4120-01-C
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