81_FR_52052 81 FR 51901 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2016

81 FR 51901 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2016

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

Federal Register Volume 81, Issue 151 (August 5, 2016)

Page Range51901-51914
FR Document2016-18546

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.

Federal Register, Volume 81 Issue 151 (Friday, August 5, 2016) 
[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)]
[Notices]
[Pages 51901-51914]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

    Dated: July 27, 2016.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
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[FR Doc. 2016-18546 Filed 8-4-16; 8:45 am]
 BILLING CODE 4120-01-C

Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 51901 marketing rights to a generic with new entry by Mylan. Thus, absent To remedy competitive concerns carisoprodol product that was recently a remedy, the proposed acquisition will raised by the acquisition in the market approved by the FDA. Once it begins likely cause U.S. consumers to pay for generic 250 mg carisoprodol tablets, marketing generic carisoprodol, Mylan significantly higher prices for 250 mg the proposed Order requires Mylan to likely would have been the third generic carisoprodol tablets. terminate its agreement with Indicus supplier of generic carisoprodol tablets. that gives Mylan the exclusive right to IV. The Consent Agreement Mylan is one of a limited number of market and sell in the United States all suppliers capable of entering the United The proposed Consent Agreement strengths of carisoprodol tablets States market in the near future. remedies the competitive concerns manufactured by Indicus. Indicus has raised by the acquisition in the markets existing relationships with suppliers of II. Entry at issue by requiring Mylan to divest all generic drugs that it can and expects to Entry into the three relevant markets its rights and assets relating to 400 mg use to replace Mylan as its marketing would not be timely, likely, or sufficient and 600 mg generic felbamate tablets to partner for its carisoprodol products. in magnitude, character, and scope to Alvogen. Founded in 2009, Alvogen is The purpose of this analysis is to deter or counteract the anticompetitive an international pharmaceutical facilitate public comment on the effects of the proposed acquisition. The company with commercial operations in proposed Consent Agreement, and it is combination of drug development times thirty-four countries. In addition, the not intended to constitute an official and regulatory requirements, including proposed Consent Agreement requires interpretation of the proposed Order or approval by the United States Food and Mylan to return its rights to market to modify its terms in any way. Drug Administration (‘‘FDA’’), is costly generic carisoprodol tablets in the and lengthy. United States to Indicus, the abbreviated By direction of the Commission. new drug application owner for this Donald S. Clark, III. Effects Secretary. product. The proposed acquisition likely The Commission’s goal in evaluating [FR Doc. 2016–18563 Filed 8–4–16; 8:45 am] would cause significant anticompetitive possible purchasers of divested assets is BILLING CODE 6750–01–P harm to consumers by eliminating to maintain the competitive competition between Mylan and Meda environment that existed prior to the in the markets for 400 mg and 600 mg proposed acquisition. If the Commission generic felbamate tablets. Market determines that Alvogen is not an DEPARTMENT OF HEALTH AND participants characterize generic acceptable acquirer, or that the manner HUMAN SERVICES felbamate tablets as commodity of the divestitures is not acceptable, the products, and prices are inversely Centers for Medicare & Medicaid proposed Order requires Mylan to correlated with the number of unwind the sale of rights to Alvogen Services competitors in each market. As the and then divest the products to a [CMS–9098–N] number of suppliers offering a Commission-approved acquirer within therapeutically equivalent drug six months of the date the Order Medicare and Medicaid Programs; increases, the price for that drug becomes final. The proposed Order Quarterly Listing of Program generally decreases due to the direct further allows the Commission to Issuances—April Through June 2016 competition between the existing appoint a trustee in the event the parties suppliers and each additional supplier. fail to divest the products as required. AGENCY: Centers for Medicare & The proposed acquisition would The proposed Consent Agreement and Medicaid Services (CMS), HHS. combine two of three companies Order contain several provisions to help ACTION: Notice. offering the 400 mg and 600 mg ensure that the divestitures are strengths of generic felbamate tablets, successful. The proposed Order requires SUMMARY: This quarterly notice lists likely leading consumers to pay higher that Mylan transfer its manufacturing CMS manual instructions, substantive prices. technology for felbamate to Alvogen and and interpretive regulations, and other In addition, the proposed acquisition provide transitional services to assist Federal Register notices that were likely would cause significant Alvogen in establishing its published from April through June anticompetitive harm to consumers by manufacturing capabilities and securing 2016, relating to the Medicare and eliminating future competition that all of the necessary FDA approvals. The Medicaid programs and other programs would otherwise have occurred in the transitional services include technical administered by CMS. 250 mg generic carisoprodol market if assistance to manufacture the product in FOR FURTHER INFORMATION CONTACT: It is Mylan and Meda remained substantially the same manner and possible that an interested party may independent. The evidence shows that quality employed or achieved by Mylan, need specific information and not be anticompetitive effects are likely to and advice and training from able to determine from the listed result from the proposed acquisition knowledgeable employees of Mylan. In information whether the issuance or due to the elimination of an additional addition, Mylan must supply Alvogen regulation would fulfill that need. independent entrant in the market for with 400 mg and 600 mg generic Consequently, we are providing contact 250 mg generic carisoprodol. Customers felbamate tablets until Alvogen is able persons to answer general questions expect that the price of this to manufacture generic felbamate concerning each of the addenda pharmaceutical product will decrease successfully in commercial quantities. published in this notice. mstockstill on DSK3G9T082PROD with NOTICES Addenda Contact Phone number I CMS Manual Instructions ....................................................................................................... Ismael Torres ..................... (410) 786–1864 II Regulation Documents Published in the Federal Register .................................................. Terri Plumb ......................... (410) 786–4481 III CMS Rulings ......................................................................................................................... Tiffany Lafferty ................... (410) 786–7548 IV Medicare National Coverage Determinations ...................................................................... Wanda Belle, MPA ............. (410) 786–7491 V FDA-Approved Category B IDEs .......................................................................................... John Manlove ..................... (410) 786–6877 VerDate Sep<11>2014 17:42 Aug 04, 2016 Jkt 238001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\05AUN1.SGM 05AUN1

51902 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices Addenda Contact Phone number VI Collections of Information ..................................................................................................... Mitch Bryman ..................... (410) 786–5258 VII Medicare-Approved Carotid Stent Facilities ........................................................................ Sarah Fulton, MHS ............ (410) 786–2749 VIII American College of Cardiology—National Cardiovascular Data Registry Sites .............. Sarah Fulton, MHS ............ (410) 786–2749 IX Medicare’s Active Coverage-Related Guidance Documents ............................................... JoAnna Baldwin, MS .......... (410) 786–7205 X One-Time Notices Regarding National Coverage Provisions ............................................... JoAnna Baldwin, MS .......... (410) 786–7205 XI National Oncologic Positron Emission Tomography Registry Sites .................................... Stuart Caplan, RN, MAS .... (410) 786–8564 XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities ................. Linda Gousis, JD ................ (410) 786–8616 XIII Medicare-Approved Lung Volume Reduction Surgery Facilities ....................................... Sarah Fulton, MHS ............ (410) 786–2749 XIV Medicare-Approved Bariatric Surgery Facilities ................................................................ Sarah Fulton, MHS ............ (410) 786–2749 XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ........................ Stuart Caplan, RN, MAS .... (410) 786–8564 All Other Information ................................................................................................................... Annette Brewer .................. (410) 786–6580 SUPPLEMENTARY INFORMATION: Health Service Act. We also issue accessibility. In addition, many of the various manuals, memoranda, and Web sites have listservs; that is, the I. Background statements necessary to administer and public can subscribe and receive The Centers for Medicare & Medicaid oversee the programs efficiently. immediate notification of any updates to Services (CMS) is responsible for Section 1871(c) of the Act requires the Web site. These listservs avoid the administering the Medicare and that we publish a list of all Medicare need to check the Web site, as manual instructions, interpretive rules, notification of updates is automatic and Medicaid programs and coordination statements of policy, and guidelines of sent to the subscriber as they occur. If and oversight of private health general applicability not issued as assessing a Web site proves to be insurance. Administration and oversight regulations at least every 3 months in difficult, the contact person listed can of these programs involves the the Federal Register. provide information. following: (1) Furnishing information to Medicare and Medicaid beneficiaries, II. Format for the Quarterly Issuance III. How To Use the Notice health care providers, and the public; Notices and (2) maintaining effective This quarterly notice provides only This notice is organized into 15 communications with CMS regional the specific updates that have occurred addenda so that a reader may access the offices, state governments, state in the 3-month period along with a subjects published during the quarter Medicaid agencies, state survey hyperlink to the full listing that is covered by the notice to determine agencies, various providers of health available on the CMS Web site or the whether any are of particular interest. care, all Medicare contractors that appropriate data registries that are used We expect this notice to be used in process claims and pay bills, National as our resources. This is the most concert with previously published Association of Insurance Commissioners current up-to-date information and will notices. Those unfamiliar with a (NAIC), health insurers, and other be available earlier than we publish our description of our Medicare manuals stakeholders. To implement the various quarterly notice. We believe the Web should view the manuals at http:// statutes on which the programs are site list provides more timely access for www.cms.gov/manuals. based, we issue regulations under the beneficiaries, providers, and suppliers. Dated: July 27, 2016. authority granted to the Secretary of the We also believe the Web site offers a Department of Health and Human more convenient tool for the public to Kathleen Cantwell, Services under sections 1102, 1871, find the full list of qualified providers Director, Office of Strategic Operations and 1902, and related provisions of the for these specific services and offers Regulatory Affairs. Social Security Act (the Act) and Public more flexibility and ‘‘real time’’ BILLING CODE 4120–01–P mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 17:42 Aug 04, 2016 Jkt 238001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\05AUN1.SGM 05AUN1

mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 Publication Dates for the Previous Four Quarterly Notices arrangements to transfer material to a local library not designated as an We publish this notice at the end of each quarter reflecting FDL. Contact any library to locate the nearest FDL. This information is 17:42 Aug 04, 2016 information released by CMS during the previous quarter. The publication available at http://www.gpo.gov/libraries/ dates of the previous four Quarterly Listing of Program Issuances notices In addition, individuals may contact regional depository libraries are: August 3, 2015 (80 FR 45980) November 13, 2015 (80 FR 70218), that receive and retain at least one copy of most federal government February 4, 2016 (81 FR 6009) and May 9, 2016 (81 FR 28072). We are publications, either in printed or microfilm form, for use by the general Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices providing only the specific updates that have occurred in the 3-month public. These libraries provide reference services and interlibrary loans; period along with a hyperlink to the website to access this information and a however, they are not sales outlets. Individuals may obtain information Jkt 238001 contact person for questions or additional information. about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing Addendum 1: Medicare and Medicaid Manual Instructions entitled Medicare and Medicaid Manual Instructions. To help FDLs locate PO 00000 (April through June 2016) the materials, use the CMS publication and transmittal numbers. For The CMS Manual System is used by CMS program components, example, to find the manual for Medicare Internet Only Manual Publication partners, providers, contractors, Medicare Advantage organizations, and 100-04 Chapter 26- Completing and Processing Form CMS-1500 Data Set State Survey Agencies to administer CMS programs. It offers day-to-day (CMS-Pub. 100-04) Transmittal No. 3490. Frm 00064 operating instmctions, policies, and procedures based on statutes and Addendum I lists a unique CMS transmittal number for each regulations, guidelines, models, and directives. In 2003, we transformed the instmction in our manuals or program memoranda and its subject number. CMS Program Manuals into a web user-friendly presentation and renamed A transmittal may consist of a single or mtutiple instmction(s). Often, it is Fmt 4703 it the CMS Online Manual System. necessary to use information in a transmittal in conjunction with information currently in the manual. For the purposes of this quarterly How to Obtain Manuals notice, we list only the specific updates to the list of manual instmctions Sfmt 4725 The Internet-only Manuals (IOMs) are a replica of the Agency's that have occurred in the 3-month period. This information is available on official record copy. Paper-based manuals are CMS manuals that were our website at www.cms.gov/Manuals. officially released in hardcopy. The majority of these manuals were E:\FR\FM\05AUN1.SGM transferred into the Internet-only manual (10M) or retired. Pub 15-1, Pub Transmittal Manual/Subject/Publication Number 15-2 and Pub 45 are exceptions to tlris nile and are still active paper-based Number Medicare General Iilfomtion (CMS-Puh 100-01) I manuals. The remaining paper-based manuals are for reference pmposes 99 Medicare Fee-for-Service Change Request Correction and Rescind Process only. If you notice policy contained in the paper-based manuals that was 100 Medicare fee-for-Service Change Request Correction and Rescind Process not transferred to the 10M, send a message via the CMS Feedback tool. Change Management Process (Electronic Change Information Management Those wishing to subscribe to old versions of CMS manuals should Portal contact the National Technical Information Service, Department of Medicare Benefit Policy (CMS-Pub. 100-02) I 222 Revisions to Private Contracting/Opt-Out Manual Sections Due to the 05AUN1 Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone Mt:dicart: (703-605-6050). You can download copies of the listed material free of Access and CHIP Reauthorization Act of 2015 (MACRA) Nonparticipating charge at: http://cms.gov/manuals. Physicians or Practitioners Who Opt-Out of Medicare Physicians or Practitioners Who Choose to Opt-Out of Medicare Opt-Out Relationship to Noncovered Services How to Review Transmittals or Program Memoranda Maintaining Infonnation on Opt-Out Physicians Those wishing to review transmittals and program memoranda can Informing Medicare Managed Care Plans of the Identity of the Opt-Out access this information at a local Federal Depository Library (FDL). Under Physicians or Practitioners the FDL program, government publications are sent to approximately 1,400 Emergency and Urgent Care Situations Mandatory Claims Submission designated libraries throughout the United States. Some FDLs may have Cancellation of Opt-Out 51903 EN05AU16.026</GPH>

FO6GLG Early Termination of Opt—Out to be Accepted Appeal Completing the Uniform (Institutional Provider) Bill (Form CMS 1450) for Claims Denial Notices to Opt—Out Physicians and Practitioners Hospice Election 223 Clarification of Inpatient Psychiatric Facilities (IPF) Requirements for Service Intensity Add—on (SIA) Payments Certification, Recertification and Delayed/Lapsed Certification and Frequency of Billing and Same Day Billing Recertification 3503 Billing of Vaccine Services on Hospice Claims 224 Update to Pub. 100—02, Chapter 11 End—Stage Renal Disease (ESRD) for Payer Only Codes Utilized by Mcedicare Calendar Year (CY) 2016 Hospice Claims for Vaceine Services saononN/ 910z ‘g jsnSny ‘KepHU4/TIST ‘ON ‘I8 ‘TOA /JoistSay jedopaq . Medicare National Coverage Determination (CMS—Pub. 100—03 Billing Requirements 191 Stem Cell Transplantation for Multiple Myeloma, Myelofibrosis, Sickle Cell Claims Submitted to MACs Using Institutional Formats Disease, and Myelodysplastic Syndromes Payment for Preumococcal Pneumonia Virus, Influenza Virus, and Hepatitis 192 Percutancous Left Atrial Appendage Closure (LAAC) B Virus Vaccines and Their Administration on Institutional Claims 193 Stem Cell Transplantation for Multiple Myeloma, Myelofibrosis, Sickle Cell Institutional Claims Submitted by Home Health Agencies and Hospice Disease, and Myelodysplastic Syndromes Payment Procedures for Renal Dialysis Facilities (RDF) Stem Cell Transplantation9Formerly 110.8.1)(Various Effective Dates 3504 Revision of the Method to Calculate the Length of Stay (LOS) Edit for Below) Continuous Invasive Mechanical Ventilation for Greater than 96 Consecutive Medicare Claims Processing (CMS—Pub, 100—04) _ Hours 3490 Medicare Internet Only Manual Publication 100—04 Chapter 26 — Completing Medicare Code Editor (MCE) and Processing Form CMS—1500 Data Set 3505 Issued to a specific audience, not posted to Internet/Intranet due to 3491 Payment for Purchased Durable Medical Equipment, Prostheli¢s, Ortholics, Confidentiality of Instruction and Supplies (DMEPOS) Furnished to Medicare Beneficiaries Residing 3506 Issued to a specific audience, not posted to Internet/Intranet due to Outside the U.S. — Expatriate Beneficiaries Confidentiality of Instruction 3492 Issued to a specific audience, not posted to Internet/Intranet due to 3507 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Confidentiality of Instruction 3493 Payment Change for Group 3 Complex Rehabilitative Power Wheelchair 3508 JW Modifier: Drug amount discarded/not administered to any patient Accessorics and Scat and Back Cushions under Seetion 2 of the Patient Discarded Drugs and Biologicals Access and Medicare Protection Act (PAMPA) 3509 Stem Cell Transplantation for Multiple Myeloma, Myelofibrosis, Sickle Cell 3494 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Discase, and Myclodysplastic Syndromes Instruction Stem Cell Transplantation 3495 Indian Health Services (IHS) Hospital Payment Rates for Calendar Year 2016 Billing for Stem Cell Transplantation 3496 Issued to a specific audience, not posted to Internet/Intranet due to Billing for Autologous Stem Cell Transplants Confidentiality of Instruction Billing for Allogeneic Stem Cell Transplants Stem Cell Transplantation 3497 Issued to a specific audience, not posted to Inteme/Intranet due to 3510 Updates to Pub. 100—04, Chapters 1 and 16 to Correct Remittance Advice Confidentiality of Instruction Messages 3498 Issued to a specific audience, not posted to Internet/Intranet due to Claims Processing Instructions for Payment Jurisdiction Confidentiality of Instruction An A/B MAC (B) Receives a Claim for Services that are in Another A/B 3499 Issued to a specific audience, not posted to Internet/Intranet due to MAC (B)‘s Payment Jurisdiction Confidentiality of Instruction An A/B MAC (B) Receives a Claim for Services that are in a DME Payment 3500 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Jurisdiction Competitive Bidding Program (CBP): Additional Instructions for the A DME MAC Receives a Claim for Services that are in an A/B MAC (B) Implementation of Round 2 Recompete of the DMEPOS CBP and National Payment Jurisdiction Mail Order (NMO) Recompete An A/B MAC (B) Receives a Claim for an RRB Beneficiary Payment of a Part of a DMEPOS Item An A/B MAC (B) or DME MAC Receives a Claim for a UMWA Payment for Capped Rental Items Beneficiary Payment for Inexpensive or Routinely Purchased Items A DME MAC receives a Paper Claim with Items or Services that are in Payment for Repair and Replacement of Beneficiary—Owned Equipment Another DME MAC‘s Payment Jurisdiction 3501 Issued to a specific audience, not posted to Internet/Intranet due to Deported Medicare Beneficiaries Confidentiality of Instruction Processing Claims for Services of Participating Physicians or Suppliers 3502 Making Principal Diagnosis Codes Mandatory for Notice of Election (NOE) Charges for Missed Appointments

mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 Coding That Results from Processing Noncovered Charges 3528 Quarterly Update to the Medicare Physician Fee Schedule Database Handling Incomplete or Invalid Claims (MPFSDB) - July CY 2016 Update 17:42 Aug 04, 2016 AlB MAC (B) Data Element Requirements 3529 Instructions for Downloading the Medicare ZIP Code File for October 2016 Conditional Data Element Requirements for AlB MACs and DMEMACs 1510 .TW Modifier: Drug amount discarded/not administered to any patient AIR MAC (R) Specific Requirements for Certain Specialties/Services Discarded Drugs and Biologicals General Explanation of Payment 3531 July 2016 Update of the Ambulatory Surgical Center (ASC) Payment System Assignment Required 3532 Annual Update of the Intemational Classification of Diseases, Tenth Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices Physician Notification of Denials Revision, Clinical Moditlcation (IClJ-10-CM) Reasons for Denial - Physician Office Laboratories Out-of-Compliance 3533 Payments to Home Health Agencies That Do Not Submit Required Quality Jkt 238001 3511 Changes to the Fiscal Intermediary Shared System (FISS) Inpatient Provider Data Specific File (PSF) for Low-Volume Hospital Payment Adjustment Factor 3534 Issued to a specific audience, not posted to IntemeVIntranet due to and New Inpatient Prospective Payment System (IPPS) Pricer Output Field Confidentiality of Instruction for Islet Isolation Add-on Payment A/Provider Specific File 3535 Payment Change for Group 3 Complex Rehabilitative Power Wheelchairs Procedure for Medicare Contractors to Perform and Record Outlier PO 00000 Accessories and Seat and Back Cushions under Section 2 ofthe Patient Reconciliation Adjustments Access and Medicare Protection Act (PAMPA) 3512 Issued to a specific audience, not posted to IntemeVIntranet due to 3536 Issued to a specific audience, not posted to IntemeV Intranet due to Sensitivity Confidentiality of Instruction Instruction 3513 Issued to a specific audience, not posted to IntemeVIntranet due to Frm 00066 3537 Corrections to Chapter 1 of the Medicare Claims Processing 'v!anual Confidentiality of Instruction Claims Submitted for Items or Services Fumished to Medicare Beneficiaries 3514 Issued to a specific audience, not posted to IntemeVIntranet due to in State or Local Custody Under a Penal Authority Confidentiality of h1struction Application to Special Claim Types 3515 Percutaneous Left Atrial Appendage Closure (LAAC) Payer Ouly Codes Utilized bv Medicare Fmt 4703 3516 Issued to a specific audience, not posted to IntemeVIntranet due to 3538 JW Modifier: Drug amount discarded/not administered to any patient Confidentiality of Instruction Discarded Drugs and Biologicals 3517 Issued to a specific audience, not posted to IntemeVIntranet due to Sensitivity 3539 Issued to a specific audience, not posted to hitemeVhitranet due to Instruction Sfmt 4725 Confidentiality of Instruction 3518 Quarterly Healthcare Common Procedure Coding System (HCPCS) 3540 Billing ofVaccine Services on Hospice Claims Drug/Biological Code Changes- July 2016 Update Hospice Claims for Vaccine Services 3519 Corrections to Chapter 1 of the Medicare Claims Processing 'v!anual Rilling Requirements Claims Submitted for Items or Services Fumished to Medicare Beneficiaries E:\FR\FM\05AUN1.SGM Claims Submitted to MACs Using Institutional Formats in State or Local Custody Under a Penal Authority Payment for Pneumococcal Pneumonia Virus, Influenza Virus, and Application to Special Claim Type Hepatitis B Payer Only Codes Utilized by Medicare Virus Vaccines and Their Administration on Institutional Claims 3520 2016 Durable Medical Equipment Prosthetics, Orthotics, and Supplies Institutional Claims Submitted by Home Health Agencies and Hospices Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction Payment Procedures for Renal Dialysis Facilities (RDF) List 3541 Issued to a specific audience, not posted to IntemeVIntranet due to 3521 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Confidentiality of Instruction 3542 Issued to a specific audience, not posted to IntemeVIntranet due to 05AUN1 3522 Update to Intemet-Ouly-Manual Publication 100-04, Chapter 18, Section 30.6 Confidentiality of Instruction Screening Pap Smears: Diagnoses Codes 3543 Issued to a specitlc audience, not posted to hitemeVhitranet due to 3523 July 2016 Update ofthe Hospital Outpatient Prospective Payment System Confidentiality of Instruction (OPPS) 1544 New Physician Specialty Code for Dentist Billing Instructions for IMRT Planning and Delivery Physician Specialty Codes 3524 July 2016 Integrated Outpatient Code Editor (IIOCE) Specifications Version 3545 Issued to a specific audience, not posted to IntemeVIntranet due to 17.2 Confidentiality of Instruction 3525 Common Edits and Enhancements Modules (CEM) Code Set Update 3546 October Quarterly Update to 2016 Annual Update ofHCPCS Codes Used tor 3526 Issued to a specitlc audience, not posted to IntemeVIntranet due to Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement Confidentiality of Instruction 1547 New Physician Specialty Code for Dentist 1527 Claim Status Category and Claim Status Codes 1 Jpdate 3548 Issued to a specific audience, not posted to IntemeVIntranet due to 51905 EN05AU16.028</GPH>

mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 51906 Confidentiality of Instruction Medicare Secondary Payer (CMS-Pub. 100-05) I 3549 Pub. 100-04, Chapter 29- Appeals of Claims Decisions Update: Revisions to 117 None Remote Identity Prootlng (Rll)P) and Multi-Factor Authentication 17:42 Aug 04, 2016 Timeliness Requirements for Forwarding Misfiled Appeal Requests, (MFA) for Electronic Correspondence Referral System (ECRS) Web Users Reconsideration Request Fonn, and Guidelines for Writing Appeals 118 Individuals Not Subject to the Limitation on Medicare Secondary Payment Correspondence (MSP) Glossary Medicare Fillllllcial Mamtgement (CMS-Pub. 100-06) I CMS Decisions Subject to the Administrative Appeals Process 266 Notice of"\few Interest Rate for Medicare Overpayments and Underpayments Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices Who May Appeal -3rd Qtr Notification for FY 20 16 Steps in the Appeals Process: Overview 267 Notice of \few Interest Rate for Medicare Overpayments and Underpayments Jkt 238001 Where to Appeal -3rd Qtr Notification for FY 2016 Conditions and Examples That May Establish Good Cause for Late Filing 268 New Physician Specialty Code for Dentist by Beneficiaries 269 New Physician Specialty Code for Dentist Amount in Controversy General Requirements Physician/Limited License Physician Specialty Codes Principles for Determining Amount in Controversy PO 00000 Meilieare State Operation Mimual (CMS-Pub. 100-07) I Parties to an Appeal Revisions to the State Operations Manual (SOM)- Chapter 2 154 How to Make and Revoke an Appointment Fxit Conference A Appeals of Claims Involving Excluded Providers, Physicians, or Other Introductory Remarks Suppliers Frm 00067 B Ground Rules Reading Levels C Presentation of Finding General Information D Closure Filing a Request for Redetennination Limitations on Technical Assistance Afforded by Surveyors Time Limit for Filing a Request for Redetermination 155 Revisions to the State Operations Manual (SOM) -Chapter 5 Fmt 4703 T11e Redetennination Survey Exit Conference and Report to the Provider/Supplier The Redetermination Decision Task 7: Exit Conference Dismissals 156 Post-Survey Certification Actions for Nursing Homes Medicare Redetermination Notice (For Partly or Fully Unfavorable Sfmt 4725 Survey Protocol for Long Tenn Care Facilities- Pmt 1/IV Deficiency Redeterminations Categorization/E. Psychosocial Outcome Severity Guide Filing a Request for a Reconsideration Time Limit for Filing a Request for a Reconsideration 157 Revisions to the State Operations Manual (SOM) -Appendix PP- Guidance Contractor Responsibilities -General to Surveyors for Long Term Care Facilities E:\FR\FM\05AUN1.SGM QIC Jurisdictions Medleare.Prow-am.Intell)ity (CMS-Pub. 100-08) I Tracking Cases 643 Issued to a specific audience, not posted to Intemet/Intranet due to Requests for an AU Hearing Confidentiality of Instruction 3550 New Waived Tests 644 Issued to a specific audience, not posted to Inteniet/Intranet due to 3551 July Quarterly Update for 2016 Durable Medical Equipment, Prosthetics, Confidentiality of Instruction Orthotics and Supplies (DMEPOS) Fee Schedule 645 Issued to a specific audience, not posted to Intemet/Intranet due to 3552 July 2016 Update of the Hospital Outpatient Prospective Payment System Confidentiality of Instruction (OPPS) 646 Issued to a specific audience, not posted to Intemet/Intranet due to 3553 New Condition Code for Reporting Home Health Episodes With No Skilled Confidentiality of h1struction 05AUN1 Visits 647 Issued to a specific audience, not posted to Intemet/Intranet due to 3554 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics Confidentiality of Instruction and Supplies (DMEPOS) Competitive Bidding Program (CBP) - October 648 Issued to a specific audience, not posted to Intemet/Intranet due to 2016 Confidentiality ofTnstruction 3555 Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System 649 Issued to a specific audience, not posted to Intemet/Intranet due to (PPS) Pricer Update FY 2017 Confidentiality of Instruction 650 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction 651 Medical Review of Skilled Nursing Facility Prospective Payment System (SNF PPS) Bills 652 Issued to a specific audience, not posted to Intemet/Intranet due to EN05AU16.029</GPH>

Confidentiality of Instruction Instruction 653 Issued to a specific audience, not posted to Internet/Intranet due to 149 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Confidentiality of Instruction Instruction 654 Issued to a specific audience, not posted to Internet/Intranet due to \One Time Notification (CMS—Pub. 100—20 Confidentiality of Instruction 1641 Issued to a specific audience, not posted to Internet/ Intranetto Sensitivity of ‘Medicare Contractor Beneficiary and Provider Communications (CMS—Pub. 100—09) Instruction 1642 Implementation of the Award for Jurisdiction A Durable Medical Equipment Medicare Qualit ganization (CMS— Pub. 100—10) (DME) Medicare Administrative Contractor (MAC) Workload saononN/ 910z ‘g jsnSny ‘KepHU4/TIST ‘ON ‘I8 ‘TOA /JoistSay jedopaq 25 QIO Manual Chapter 11 — Hospitl Payment Monitoring Program (HPMP) 1643 Issued to a specific audience, not posted to Internet/ Intranct to Sensitivity of 26 QIO Manual Chapter 2 — Eligibility Instruction 27 QIO Manual Chapter 12 "Communications, Outreach, and Program—related 1644 Reclassification of Certain Durable Medical Equipment HCPCS Codes Information Activities" Included in Competitive Bidding Programs (CBP) from the Inexpensive and Medicare End Stage Renal Disease Network Organizations (CMS Pub 100—14 Routinely Purchased Payment Category to the Capped Rental Payment s None Category Medicaid Program Integrity Disease Network Org: 1645 Analysis of the Combined Common Edits/Enhancements Module (CCEM) [1 Medicare Managed Care (CMS—Pub. 100—16 1646 3rd Party Software Upgrade (Jaspersoft) reporting software for the Combined Common 121 Chapter 4, Benefits and Beneficiary Protections Edits/Enhancement Module (CCEM) General Requirements 1647 Payment Change for Group 3 Complex Rehabilitative Power Wheelchairs Basic Rule Accessories and Seat and Back Cushions under Section 2 of the Patient Exceptions to Requirements for MA plans to Cover FFS Benefits Access and Medicare Protection Act (PAMPA) for Home Health Claims Types of Benefits 1648 Issued to a specific audience, not posted to Internet/ Intranetto Sensitivity of Hospice Coverage Instruction Uniformity 1649 Phase 2 of Updating the Fiscal Intermediary Shared System (FISS) to Make Anti—Discrimination Payment for Drugs and Biologicals Services for Outpatient Prospective Review for Discrimination and Steering Confidentiality Payment System (OPPS) Providers Multiple Plan Offerings and Benefit Caps 1650 Shared System Enhancement 2015: Archive/Remove Inactive Medicare Payment for Investigational Device Exemption (IDE) Studies Demonstration Projects Return to Enrollee‘s Home Skilled Nursing Facility (SNF) 1651 National Provider Identifier Crosswalk System (NPICS) Retirement Analysis Therapy Caps and Exceptions Only — Engage Shared Systems Maintainers and Medicare Administrative 122 Chapter 14, Contract Determinations and Appeals Contractors (MAC‘s) in Meetings and Correspondence Related to the NPICS Medicare Business Partners Systems Security (CMS—Pub. 100—17 Retirement with the Stakeholders _2 None 1652 Analysis Only: To Obtain a Rough Order of Magnitude (ROM) from Durable Demonstrations (CMS—Pub. 100—19) Medical Equipment Medicare Administrative Contractors (DME MACs), 142 Affordable Care Act Bundled Payments for Care Improvement Initiative — GDIT/VMS, the National Supplier Clearinghouse (NSC) and the Common Recurring File Updates Models 2 and 4 July 2016 Updates Electronic Data Interchange (CEDI) Contractor to Develop and Implement a 143 Implementing Payment Changes for FCIIIP (Frontier Community Mealth Process for DME MAC Provider Self—Service Internet Portal Authentication Integration Project), Mandated by Section 123 of MIPPA 2008 and as of Medicare Providers Using EDI Enrollment Data Elements Amended by Section 3126 of the ACA of 2010 (This CR Rescinds and 1653 New State Code for AZ, ID, NY, and WV Replaces CR8683) 1654 System Changes to Implement Section 231 of the Consolidated 144 Issued to a specific audience, not posted to Internet/ Intranetto Appropriations Act, 2016, Temporary Exception for Certain Severe Wound Confidentiality of Instruction Discharges From Certain Long—Term Care Hospitals (LTCHs) 145 Update to the Common Working File Edits for 69678 — Oncology Care 1655 Recurring calls with the Fiscal Intermediary Shared System (FISS) for any in— Model Service depth discussions 146 Oncology Care Model (OCM) Monthly Enhanced Oncology Services 1656 Issued to a specific audience, not posted to Internet/ Intranetto Sensitivity of (MEOS) Payment Implementation Instruction 147 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 1657 Issuing Continuing Compliance Letters to Specific Providers and Suppliers Instruction 1658 Coding Revisions to National Coverage Determinations 148 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 1659 Convert Assembler Code to COBOL or Best Coding Language to Improve LO6IG

8061S MCS System Maintainability and Sustainability, Analysis only. information on how to access electronic editions, printed editions, and 1660 Shared Savings Program (SSP) Accountable Care Organization (ACO) reference copies. Qualifying Stay Edits 1661 Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of This information is available on our website at: Instruction http://www.cms. gov/quarterlyproviderupdates/downloads/Regs— 1662 Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of 2Q16QPU.pdf Instruction For questions or additional information, contact Terri Plumb 1663 Issued to a specific audience, not posted to Internet/ Intranet to saononN/ 910z ‘g jsnSny ‘KepHU4/TIST ‘ON ‘I8 ‘TOA /JoistSay jedopaq (410—786—4481). Confidentiality of Instruction 1664 Reporting Medicare Administrative Contractor (MAC) Provider Education Addendum III:; CMS Rulings Website Analytic Data to the Provider Customer Service Program Contractor Information Database (PCID) (April through June 2016) 1665 Coding Revisions to National Coverage Determinations (NCDs) CMS Rulings are decisions of the Administrator that serve as 1666 Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of precedent final opinions and orders and statements of policy and Instruction interpretation. They provide clarification and interpretation of complex or 1667 Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of ambiguous provisions of the law or regulations relating to Medicare, Instruction 1668 National Provider Identifier Crosswalk System (NPICS) Retirement Analysis Medicaid, Utilization and Quality Control Peer Review, private health Only — Engage Shared Systems Maintainers and Medicare Administrative insurance, and related matters. Contractors (MACs) in Meetings and Correspondence Related to the NPICS The rulings can be accessed at http://www.cms. gov/Regulations— Retirement with the Stakeholders and—Guidance/Guidance/Rulings. For questions or additional information, 1669 Guidance on Implementing System Edits for Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) contact Tiffany Lafferty (410—786—7548). 1670 Shared System Enhancement 2014 — Identification of Fiscal Intermediary Standard System (FISS) Obsolete Reports — Analysis Only Medicare Quality Reporting Incentive Programs (CMS— Pub. 100—22 57 Payments to Home Health Agencies That Do Not Submit Required Quality Data Information Security Acceptable Risk Safeguards (CMS—Pub. 100—2 None 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 http:/www.gpoaccess.gov/fr/index.html. The following website http://www.archives.gov/federal—register/ provides

mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 number. For the purposes of this quarterly notice, we list only the specific Addendum IV: Medicare National Coverage Determinations updates to the Category BIDEs as of the ending date of the period covered 17:42 Aug 04, 2016 (April through June 2016) by this notice and a contact person for questions or additional information. Addendum IV includes completed national coverage For questions or additional information, contact John Manlove (410-786- determinations (NCDs), or reconsiderations of completed NCDs, from the 6877). quarter covered by this notice. Completed decisions arc identified by the Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices section of the NCD Manual (NCDM) in which the decision appears, the fall into one of three classes. To assist CMS under this categorization Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices title, the date the publication was issued, and the effective date of the process, the FDA assigns one of two categories to each FDA-approved Jkt 238001 decision. An NCD is a determination by the Secretary for whether or not a investigational device exemption (IDE). Category A refers to experimental particular item or service is covered nationally under the Medicare Program IDEs, and Category B refers to non-experimental IDEs. To obtain more (title XVIII of the Act), but does not include a detennination of the code, if infonnation about the classes or categories, please refer to the notice any, that is assigned to a particular covered item or service, or payment published in the April21, 1997 Federal Register (62 FR 19328). PO 00000 determination for a particular covered item or service. The entries below include information concerning completed decisions, as well as sections on IDE Device Sta11 Date program and decision memoranda, which also announce decisions or, in Gl60051 Brainsway Deep TMS System utilizing the H2-coil 04113/2016 Frm 00070 Gl60053 Closing the Loop on Tremor: A Responsive Deep Brain 04/14/2016 some cases, explain why it was not appropriate to issue an NCD. Stimulator for the Treatment of Essential Tremor Information on completed decisions as well as pending decisions has also Gl60058 True Beam, True Beam STx, Edge 04/14/2016 been posted on the CMS website. For the purposes of tlris quarterly notice, 0160056 Allurion Elipse Device 04/lS/2016 Fmt 4703 we are providing only the specific updates that have occurred in the Gl60054 Repetitive Transcanial Magnetic Stimulation (rTMS) for 04/20/2016 3-month period. This information is available at: www.cms.gov/medicare- Obsessive-Compulsive Disorder Gl60061 Spatz3 Adjustable Balloon System 04/20/2016 coverage-database/. For questions or additional information, contact Gl60065 iNod Biopsy Needle, iNod Ultrasound Catheter, iNod 04/2112016 Sfmt 4725 Wanda Belle, MPA (410-786-7491). Ultrasound Imaging System, iNod Motor Drive Unit, iNod Sled Title NCDM Transmittal Issue Date Effective Gl60063 HEMOBLAST Bellows Hemostatic Agent 04/22/2016 Section Number Date Gl60064 Sight Sciences VISCO 360 Viscosurgical System 04/22/2016 E:\FR\FM\05AUN1.SGM Percutaneous Left Atrial Gl60074 MAD IT S-ICD Clinical Study 04/26/2016 Appendage Closure NCD 20.34 Rl92 05/06/2016 02/08/2016 0160067 NeoChord Artificial Chordae Delivery System, Model 04/27/2016 (LAAC) DSlOOO Stem Cell Gl40102 ThermoCool SmartTouch SF Catheter 04/27/2016 Transplantation for Gl60066 Embosphere Microspheres 04/27/2016 Multiple Myeloma, Gl60071 NeuroBlate System 04/29/2016 Myelofibrosis, Sickle NCD ll0.23 Rl91 04/29/2016 01127/2016 Gl60072 Influence of Cooling duration on Efficacy in Cardiac Arrest 04/29/2016 Cell Disease, and Patients (ICECAP) trial 05AUN1 Myelodysplastic Gl60073 MED-EL Synchrony cochlear implant with the FLEX28 04/29/2016 Syndromes electrode array Gl60077 Orbera Intragastric Balloon 05/04/2016 Addendum V: FDA-A11proved Category B Investigational Device Gl60078 SJM MRI Diagnostic Imaging Registry 05/05/2016 Gl60081 \VIRION Embolic Protection System (EPS) 05/06/2016 Exemptions (IDEs) (April through June 2016) BB16430 DryThaw-MTS1-C 05/08/2016 Addendum V includes listings of the FDA-approved Gl20246 Exablate Transcranial MRGFUS Thalmotomy Treatment 05113/2016 investigational device exemption (IDE) numbers that the FDA assigns. The Gl50199 Model SC9 Posterior Chamber Intraocular Lens 05113/2016 listings are organized according to the categories to which the devices are Gl60082 DBS Leads, Activa PC Stimulator, DBS Extension 05/14/2016 assigned (that is, Category A or Category B), and identified by the IDE Gl60084 Revanesse Ultra+ (with lidocaine) 05/17/2016 G040175 Relay Thoracic Stend Graft with Transport Delivery System 05/20/2016 51909 EN05AU16.032</GPH>

mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 51910 IDE Device Start Date All facilities must at least meet our standards in order to receive coverage for treatment of thoracic aortic aneurysms. for carotid artery stenting for high risk patients. For the purposes of this Gl60087 Aspen System 05/25/2016 17:42 Aug 04, 2016 Gl50241 Ellipse ICD and Durata and Optisure high voltage lead system 05/25/2016 quarterly notice, we are providing only the specific updates that have Gl60013 Bio Ventrix Revivent TC System 05/25/2016 occurred in the 3-month period. This information is available at: Gl60089 NovoTTF-lOOM System 05/26/2016 http://www. ems. gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage Gl60092 Bioness StimRouter Neuromodulation System, StimRouter 06/01/2016 For questions or additional information, contact Sarah Fulton, MHS Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices Lead Kit, StimRouter Surgical Tool Kit, StimRouter Clinician (410-786-2749). Kit, StimRouter User Kit Jkt 238001 Gl60093 OVT 06/01/2016 Gl60094 TSolution One TK.A. 06/01/2016 Facility Provider Effective State Number Date Gl60049 EnligHTN Renal Denervation System 06/02/2016 The following facilities are new listings for this quarter. Gl60001 Covera Vascular Covered Stent 06/03/2016 South Georgia Medical Center 1306896253 04/12/2016 GA Gl60107 ZiftLift System 06/14/2016 PO 00000 2501 N. Patterson Street Valdosta, GA 31602 Gl60105 therascreen BRAF V600E RGQ PCR Kit 06/15/2016 Baptist Memorial Hospital- North Mississippi 250034 04/12/2016 MS Gl60109 Covera Vascular Covered Stent 06/22/2016 (Baptist North Mississippi) Gl60111 MET Exon 14 Skipping Test 06/22/2016 2301 South Lamar Boulevard Oxford, MS 38655 Frm 00071 Gl50137 JUVEDERM VOLUMA XC 06/22/2016 Aurora Medical Center - Oshkosh 060112 04/21/2016 WI Gl60060 ClariCore Biopsy System 06/22/2016 855 North Westhaven Drive Oshkosh, WI 54904 Gl60110 TIVUS System, Multidirectional TIVUS Catheter (also 06/23/2016 The following facility has editorial changes (in bold). referred as TTv1 JS Catheter), TTV1 TS Console 23-0066 12/21/2005 MI FROM: Mercy General Health Partners Fmt 4703 Gl60113 SAFE - PCI in STEMI for Seniors 06/24/2016 TO: Mercy Health Partners 1500 East Sherman Boulevard Muskegon, MI49444 Addendum VI: Approval Numbers for Collections of Information Addendum VIII: Sfmt 4725 (April through June 2016) American College of Cardiology's National Cardiovascular Data All approval numbers are available to the public at Reginfo.gov. Registry Sites (April through June 2016) Under the review process, approved information collection requests are Addendum VIII includes a list of the American College of E:\FR\FM\05AUN1.SGM assigned OMB control numbers. A single control number may apply to Cardiology's National Cardiovascular Data Registry Sites. We cover several related information collections. This information is available at implantable cardioverter defibrillators (ICDs) for certain clinical www.reginfo.gov/public/do/PRAMain. For questions or additional indications, as long as information about the procedures is reported to a information, contact Mitch Bryman (410-786-5258). central registry. Detailed descriptions of the covered indications are available in the NCD. In January 2005, CMS established the lCD Addendum VII: Medicare-Approved Carotid Stent Facilities, Abstraction Tool through the Quality Network Exchange (QNet) as a (April through June 2016) temporary data collection mechanism. On October 27, 2005, CMS 05AUN1 Addendum VII includes listings of Medicare-approved carotid announced that the American College of Cardiology's National stent facilities. All facilities listed meet CMS standards for performing Cardiovascular Data Registry (ACC-NCDR) TCD Registry satisfies the data carotid artery stenting for high risk patients. On March 17, 2005, we issued reporting requirements in the NCD. Hospitals needed to transition to the our decision memorandum on carotid artery stenting. We determined that ACC-NCDR lCD Registry by April 2006. carotid artery stenting with embolic protection is reasonable and necessary Effective January 27, 2005, to obtain reimbursement, Medicare only if performed in facilities that have been determined to be competent in NCD policy requires that providers implanting ICDs for primary prevention performing the evaluation, procedure, and follow-up necessary to ensure clinical indications (that is, patients without a history of cardiac arrest or optimal patient outcomes. We have created a list of minimum standards for spontaneous arrhythmia) report data on each primary prevention lCD facilities modeled in part on professional society statements on competency. procedure. Details of the clinical indications that arc covered by Medicare EN05AU16.033</GPH>

mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 and their respective data reporting requirements are available in the (April through June 2016) Medicare NCD Manual, which is on the CMS website at CMS issued a guidance document on November 20, 2014 titled 17:42 Aug 04, 2016 "Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development Document". Although CMS has several policy A provider can use either of two mechanisms to satisfy the data vehicles relating to evidence development activities including the reporting requirement. Patients may be emolled either in an Investigational investigational device exemption (IDE), the clinical trial policy, national Device Exemption trial studying ICDs as identified by the FDA or in the coverage determinations and local coverage determinations, this guidance Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices ACC-NCDR lCD registry. Therefore, for a beneficiary to receive a document is principally intended to help the public understand CMS's Jkt 238001 Medicare-covered lCD implantation for primary prevention, the beneficiary implementation of coverage with evidence development (CED) through the must receive the scan in a facility that participates in the ACC-NCDR lCD national coverage determination process. The document is available at registry. The entire list of facilities that participate in the ACC-NCDR lCD http://www. ems. gov/medicare-coverage-database/details/medicare- registry can be found at www.ncdr.com/webncdr/common coverage-document-details.aspx?MCDld=27. There are no additional PO 00000 For the purposes of this quarterly notice, we are providing only the Active CMS Coverage-Related Guidance Documents for the 3-month specific updates that have occurred in the 3-month period. This information period. For questions or additional information, contact is available by accessing our website and clicking on the link for the JoAnna Baldwin, MS (410-786-7205). Frm 00072 American College of Cardiology's National Cardiovascular Data Addendum X: Registry at: www.ncdr.com/webncdr/common. For questions or additional List of Special One-Time Notices Regarding National Coverage information, contact Sarah Fulton, MHS (410 786 27 49). Provisions (April through June 2016) Fmt 4703 There were no special one-time notices regarding national Facility I City State coverage provisions published in the 3-month period. This information is The following facilities are new listings for this quarter. available at www.cms.hhs.gov/coverage. For questions or additional Sfmt 4725 Memorial Hermann Sugar Land Sugar Land TX Tennova-North Knoxville Medical Center Powell TN information, contact JoAnna Baldwin, MS (410-786 7205). Wichita Ambulatory Surgery Center Wichita KS Alexandria Ambulatory Surgery Center Alexandria LA Addendum XI: National Oncologic PET Registry (NOPR) E:\FR\FM\05AUN1.SGM Baytown Ambulatory Surgery Center Baytown TX (April through June 2016) Watertown Medical Center, LLC Watertown WI Addendum XI includes a listing of National Oncologic Positron Nason Medical Center, LLC Roaring Spring PA Emission Tomography Registry (NOPR) sites. We cover positron emission Trios Health Kennewick WA Memorial Hermann Pearland Pearland TX tomography (PET) scans for particular oncologic indications when they are North Metro Medical Center Jacksonville AZ performed in a facility that participates in the NOPR. Ohio Valley General Hospital McKees Rocks PA In January 2005, we issued our decision memorandum on positron HHCASC, LLC St. Louis MO emission tomography (PET) scans, which stated that CMS would cover 05AUN1 St. Bernard Parish Hospital Chalmette LA PET scans for particular oncologic indications, as long as they were Palms of Pasadena Hospital St. Petersburg FL Melrose-Wakefield Hospital Melrose MA performed in the context of a clinical study. We have since recognized the Saint Anne's Hospital Fall River MA National Oncologic PET Registry as one of these clinical studies. United Hospital System Kenosha WI Therefore, in order for a beneficiary to receive a Medicare-covered PET Watsonville Connnunity Hospital Watsonville CA scan, the beneficiary must receive the scan in a facility that participates in Bristol Regional Medical Center Bristol TN the registry. There were no additions, deletions, or editorial changes to the UPMC McKeesport McKeesport PA listing of National Oncologic Positron Emission Tomography Registry Lafayette General Southwest Lafayette LA (NOPR) in the 3-month period. This information is available at http://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. Addendum IX: Active CMS Coverage-Related Guidance Documents 51911 EN05AU16.034</GPH>

mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 51912 For questions or additional information, contact Stuart Caplan, RN, MAS Addendum XIII: Lung Volume Reduction Surgery (LVRS) (410-786-8564 ). (April through June 2016) 17:42 Aug 04, 2016 Addendum XIII includes a listing of Medicare-approved facilities Addendum XII: Medicare-Approved Ventricular Assist Device that are eligible to receive coverage for lung volume reduction surgery. (Destination Therapy) Facilities (April through June 2016) Until May 17, 2007, facilities that participated in the National Emphysema Addendum XII includes a listing of Medicare-approved facilities Treatment Trial were also eligible to receive coverage. The following three Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices that receive coverage for ventricular assist devices (VADs) used as types of facilities are eligible for reimbursement for Lung Volume destination therapy. All facilities were required to meet our standards in Reduction Surgery (LVRS): Jkt 238001 order to receive coverage for VADs implanted as destination therapy. On • National Emphysema Treatment Trial (NETT) approved (Beginning October 1, 2003, we issued our decision memorandum on V ADs for the 05/07/2007, these will no longer automatically qualify and can qualify only clinical indication of destination therapy. We determined that VADs used with the other programs); PO 00000 as destination therapy are reasonable and necessary only if performed in • Credentialed by the Joint Commission (formerly, the Joint facilities that have been determined to have the experience and Commision on Accreditation ofHealthcare Organizations (JCAHO)) under infrastructure to ensure optimal patient outcomes. We established facility their Disease Specific Certification Program for L VRS; and Frm 00073 standards and an application process. All facilities were required to meet • Medicare approved for lung transplants. our standards in order to receive coverage for VADs implanted as Only the first two types arc in the list. There were no updates to destination therapy. the listing of facilities for lung volume reduction surgery published in the We are providing only the specific updates to the list of Medicare- 3-month period. This infonuation is available at Fmt 4703 approved facilities that meet our standards that have occurred in the www. ems. gov/MedicareApprovedF acilitie/LVRS/list.asp#TopOfPage. For 3-month period. This information is available at questions or additional information, contact Sarah Fulton, MHS http://www. ems. gov/MedicareApprovedF acilitie/VAD/list. asp#TopOfPage. (410-786-27 49). Sfmt 4725 For questions or additional information, contact Linda Gousis, JD, (410-786-8616). Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (April through June 2016) E:\FR\FM\05AUN1.SGM Facility Provider Date Approved State Addendum XIV includes a listing of Medicare-approved facilities Number that meet minimum standards for facilities modeled in part on professional The following faciHiies are new Jisiings for ibis quarier. Saint Cloud Hospital 240036 04113/2016 MN society statements on competency. All facilities must meet our standards in 1406 Sixth Avenue North order to receive coverage for bariatric surgery procedures. On February 21, Saint Cloud. MN 56303 2006, we issued our decision memorandum on bariatric surgery procedures. Lubbock County Hospital District 450686 06/17/2016 TX We determined that bariatric surgical procedures are reasonable and 602 Indiana Avenue necessary for Medicare beneficiaries who have a body-mass index (BMI) 05AUN1 Lubbock, TX 79415 greater than or equal to 35, have at least one co-morbidity related to obesity Fresno Community Hospital and 1104906569 11105/2014 CA and have been previously unsuccessful with medical treatment for obesity. 'v!edical Center 2823 Fresno Street Fresno, CA 93721 This decision also stipulated that covered bariatric surgery procedures are The followinll; facility is beffiv removed as ofthis quarter. reasonable and necessary only when performed at facilities that are: (1) Albany Medical Center Hospital 133-0013 111/06/2013 certified by the American College of Surgeons (ACS) as a Levell Bariatric 43 New Scotland Avenue Albany, NY INY 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). EN05AU16.035</GPH>

mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 17:42 Aug 04, 2016 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices Jkt 238001 PO 00000 Frm 00074 There were no additions, deletions, or editorial changes to Addendum XV: FDG-PET for Dementia and Neurodegenerative Medicare-approved facilities that meet CMS' s minimum facility standards Diseases Clinical Trials (April through June 2016) Fmt 4703 for bariatric surgery that have been certified by ACS and/or ASMBS in the There were no FDG-PET for Dementia and Neurodegenerative 3-month period. This information is available at Diseases Clinical Trials published in the 3-month period. www. ems. gov/MedicareApprovedF acilitie/B SF/list.asp#TopOfPage. For This information is available on our website at Sfmt 9990 questions or additional information, contact Sarah Fulton, MHS www.cms.gov/MedicareApprovedFacilitie/PETDT!list.asp#TopOfPage. (410-786-2749). For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). E:\FR\FM\05AUN1.SGM 05AUN1 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] 1. Access CMS’ Web site address at populations: Elders (65 years and older); BILLING CODE 4120–01–C http://www.cms.hhs.gov/ younger adults (18–64) with physical PaperworkReductionActof1995. disabilities; and adults of any age with 2. Email your request, including your intellectual or developmental DEPARTMENT OF HEALTH AND address, phone number, OMB number, disabilities, with severe mental illness, HUMAN SERVICES and CMS document identifier, to or with traumatic brain injury. Paperwork@cms.hhs.gov. Individual-level data will be collected Centers for Medicare & Medicaid 3. Call the Reports Clearance Office at two times using the TEFT FASI Item Services (410) 786–1326. Set. The first data collection effort will FOR FURTHER INFORMATION CONTACT: collect data that can be analyzed to [Document Identifier: CMS–10243] evaluate the reliability and validity of Reports Clearance Office at (410) 786– 1326. the FASI items when used with the five Agency Information Collection waiver populations. Assessors will Activities: Submission for OMB SUPPLEMENTARY INFORMATION: Under the conduct functional assessments in client Review; Comment Request Paperwork Reduction Act of 1995 (PRA) homes using the TEFT FASI Item Set. (44 U.S.C. 3501–3520), federal agencies AGENCY: Centers for Medicare & Changes may be recommended to must obtain approval from the Office of Medicaid Services, HHS. individual TEFT FASI items, to be made Management and Budget (OMB) for each ACTION: Notice. prior to releasing the TEFT FASI items collection of information they conduct for use by the states. The FASI Field or sponsor. The term ‘‘collection of SUMMARY: The Centers for Medicare & Test Report will be released to the information’’ is defined in 44 U.S.C. public. Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and The second data collection will be an opportunity for the public to includes agency requests or conducted by the states to demonstrate comment on CMS’ intention to collect requirements that members of the public their use of the FASI data elements. The information from the public. Under the submit reports, keep records, or provide assessment data could be used by the Paperwork Reduction Act of 1995 information to a third party. Section states for multiple purposes. They may (PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C. use the standardized items to determine publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies individual eligibility for state programs, concerning each proposed collection of to publish a 30-day notice in the or to help determine levels of care information, including each proposed Federal Register concerning each within which people can receive extension or reinstatement of an existing proposed collection of information, services, or other purposes. In the collection of information, and to allow including each proposed extension or second round of data collection, states a second opportunity for public reinstatement of an existing collection will demonstrate their proposed uses, comment on the notice. Interested of information, before submitting the manage their FASI data collection and persons are invited to send comments collection to OMB for approval. To conduct their own analysis, to the regarding the burden estimate or any comply with this requirement, CMS is extent they propose to do such tasks. other aspect of this collection of publishing this notice that summarizes The states have been funded under the information, including any of the the following proposed collection(s) of demonstration grant to conduct the following subjects: (1) The necessity and information for public comment: round 2 data collection and analysis. utility of the proposed information 1. Type of Information Collection collection for the proper performance of These states will submit reports to CMS Request: Reinstatement with change of a describing their experience in the the agency’s functions; (2) the accuracy previously approved collection; Title of of the estimated burden; (3) ways to Round 2 data collection, including the Information Collection: Testing items they collected, how they planned enhance the quality, utility, and clarity Experience and Functional Tools: of the information to be collected; and to use the data, and the types of Functional Assessment Standardized challenges and successes they (4) the use of automated collection Items (FASI) Based on the CARE Tool; techniques or other forms of information encountered in doing so. The reports Use: In 2012, CMS funded a project may be used by CMS in their evaluation technology to minimize the information entitled, Technical Assistance to States collection burden. of the TEFT grants. for Testing Experience and Functional Subsequent to the publication of our DATES: Comments on the collection(s) of Tools (TEFT) Grants. One component of 60-day Federal Register notice (May 2, information must be received by the this demonstration is to amend and test 2016; 81 FR 26235), we have made OMB desk officer by September 6, 2016. the reliability of a setting-agnostic, several minor modifications to the form. ADDRESSES: When commenting on the interoperable set of data elements, The changes are intended to further proposed information collections, called ‘‘items,’’ that can support protect participant identification and please reference the document identifier standardized assessment of individuals improve the response efficiency by or OMB control number. To be assured across the continuum of care. Items that removing several checkboxes that we consideration, comments and were created for use in post-acute care were using for item screening purposes. recommendations must be received by settings using the Continuity The instructions were revised the OMB desk officer via one of the Assessment Record and Evaluation accordingly. The revisions have no following transmissions: OMB, Office of (CARE) tool have been adopted, impact on our 60-day burden estimates. Information and Regulatory Affairs, modified, or supplemented for use in Form Number: CMS–10243 (OMB Attention: CMS Desk Officer, Fax community-based long-term services control number: 0938–1037); Frequency: mstockstill on DSK3G9T082PROD with NOTICES Number: (202) 395–5806 or Email: and supports (CB–LTSS) programs. This On occasion; Affected Public: OIRA_submission@omb.eop.gov. project will test the reliability and Individuals and Households; Number of To obtain copies of a supporting validity of the function-related Respondents: 5,650; Total Annual statement and any related forms for the assessment items, now referred to as Responses: 5,650; Total Annual Hours: proposed collection(s) summarized in Functional Assessment Standardized 2,825. (For policy questions regarding this notice, you may make your request Items (FASI), when applied in this collection contact Allison Weaver at using one of following: community settings, and in various 410–786–4924.) VerDate Sep<11>2014 17:42 Aug 04, 2016 Jkt 238001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\05AUN1.SGM 05AUN1


Document Created: 2016-08-05 06:43:33
Document Modified: 2016-08-05 06:43:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactIt is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice.
FR Citation81 FR 51901 
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