[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Notices]
[Pages 28072-28083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10819]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9097-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--January Through March 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 January through March 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           Terri Plumb........     (410) 786-4481
 Published in the Federal
 Register.
III CMS Rulings.................  Tiffany Lafferty...     (410) 786-7548
IV Medicare National Coverage     Wanda Belle........     (410) 786-7491
 Determinations.
V FDA-Approved Category B IDEs..  John Manlove.......     (410) 786-6877
VI Collections of Information...  Mitch Bryman.......     (410) 786-5258
VII Medicare-Approved Carotid     Sarah Fulton.......     (410) 786-2749
 Stent Facilities.
VIII American College of          Sarah Fulton.......     (410) 786-2749
 Cardiology-National
 Cardiovascular Data Registry
 Sites.
IX Medicare's Active Coverage-    JoAnna Baldwin.....     (410) 786-7205
 Related Guidance Documents.
X One-time Notices Regarding      JoAnna Baldwin.....     (410) 786-7205
 National Coverage Provisions.
XI National Oncologic Positron    Stuart Caplan, RN,      (410) 786-8564
 Emission Tomography Registry      MAS.
 Sites.
XII Medicare-Approved             Linda Gousis.......     (410) 786-8616
 Ventricular Assist Device
 (Destination Therapy)
 Facilities.
XIII Medicare-Approved Lung       Sarah Fulton.......     (410) 786-2749
 Volume Reduction Surgery
 Facilities.
XIV Medicare-Approved Bariatric   Sarah Fulton, MHS..     (410) 786-2749
 Surgery Facilities.
XV Fluorodeoxyglucose Positron    Stuart Caplan, RN,      (410) 786-8564
 Emission Tomography for           MAS.
 Dementia Trials.
All Other Information...........  Annette Brewer.....     (410) 786-6580
------------------------------------------------------------------------

I. Background

    The Centers for Medicare & Medicaid Services (CMS) is responsible 
for administering the Medicare and Medicaid programs and coordination 
and oversight of private health insurance. Administration and oversight 
of these programs involves the following: (1) Furnishing information to 
Medicare and Medicaid beneficiaries, health care providers, and the 
public; and (2) maintaining effective communications with CMS regional 
offices, state governments, state Medicaid agencies, state survey 
agencies, various providers of health care, all Medicare contractors 
that process claims and pay bills, National Association of Insurance 
Commissioners (NAIC), health insurers, and other stakeholders. To 
implement the various statutes on which the programs are based, we 
issue regulations under the authority granted to the Secretary of the 
Department of Health and Human Services under sections 1102, 1871, 
1902, and related provisions of the Social Security Act (the Act) and 
Public Health Service Act. We also issue various manuals, memoranda, 
and statements necessary to administer and oversee the programs 
efficiently.
    Section 1871(c) of the Act requires that we publish a list of all 
Medicare manual instructions, interpretive rules, statements of policy, 
and guidelines of general applicability not issued as regulations at 
least every 3 months in the Federal Register.

II. Format for the Quarterly Issuance Notices

    This quarterly notice provides only the specific updates that have 
occurred in the 3-month period along with a hyperlink to the full 
listing that is available on the CMS 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

[[Page 28073]]

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: April 29, 2016.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.

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: April 24, 2015 (80 FR 23013) August 3, 2015 (80 
FR 45980) November 13, 2015 (80 FR 70218) and February 4, 2016 (81 FR 
6009). For the purposes of this quarterly notice, we are providing only 
the specific updates that have occurred in the 3-month period along 
with a hyperlink to the Web site to access this information and a 
contact person for questions or additional information.

Addendum I: Medicare and Medicaid Manual Instructions (January Through 
March 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 instructions, policies, and procedures based on statutes and 
regulations, guidelines, models, and directives. In 2003, we 
transformed the CMS Program Manuals into a web user-friendly 
presentation and renamed it the CMS Online Manual System.

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 (IOM) or retired. Pub 15-1, 
Pub 15-2 and Pub 45 are exceptions to this rule and are still active 
paper-based manuals. The remaining paper-based manuals are for 
reference purposes only. If you notice policy contained in the paper-
based manuals that was not transferred to the IOM, send a message via 
the CMS Feedback tool.
    Those wishing to subscribe to old versions of CMS manuals should 
contact the National Technical Information Service, Department of 
Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-
6050). You can download copies of the listed material free of charge 
at: http://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 http://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 Quarterly Update for the Durable Medical Equipment, Prosthetics, 
Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP)--
January 2016 (CMS-Pub. 100-04) Transmittal No. 3377.
    Addendum I lists a unique CMS transmittal number for each 
instruction in our manuals or program memoranda and its subject number. 
A transmittal may consist of a single or multiple instruction(s). 
Often, it is necessary to use information in a transmittal in 
conjunction with information currently in the manual. For the purposes 
of this quarterly notice, we list only the specific updates to the list 
of manual instructions that have occurred in the 3-month period. This 
information is available on our Web site at www.cms.gov/Manuals.

------------------------------------------------------------------------
          Transmittal No.              Manual/subject/publication No.
------------------------------------------------------------------------
             Medicare General Information (CMS-Pub. 100-01)
------------------------------------------------------------------------
97................................  Internet Only Manual (IOM)
                                     Publication 100-01-General
                                     Information, Eligibility, and
                                     Entitlement, Chapter 7--Contract
                                     Administrative Requirements,
                                     Section 40-Shared System Maintainer
                                     Responsibilities for Systems
                                     Releases.
                                       Standardized Terminology for
                                        Claims Processing Systems.
                                       Standard Terminology Chart.
                                       Release Software.
                                       Implementing Validated
                                        Workarounds for Shared System
                                        Claims Processing by All
                                        Medicare DME MACs.
                                    Shared System Testing Requirements
                                     for Shared System Maintainers,
                                     Single Testing Contractor (STC)/
                                     Beta Testers, and Part A/Part B (A/
                                     B) Durable Medical Equipment (DME)
                                     Medicare Administrative Contractors
                                     (MACs).
                                    Shared System Testing Requirements
                                     for Shared System Maintainers,
                                     Single Testing Contractor (STC),
                                     and DME MACs.
                                    Minimum Testing Standards for Shared
                                     System Maintainers and the Single
                                     Testing Contractor (STC)/Beta
                                     Testers.
                                       Testing Standards Applicable to
                                        all Beta Testers.
                                    Part A/Part B (A/B) Durable Medical
                                     Equipment (DME) Medicare
                                     Administrative Contractor (MAC)
                                     (User) Testing Requirements 7/
                                     40.3.6/Testing Requirements
                                     Applicable to all CWF Data Centers
                                     (Hosts).
                                       Timeframe Requirements for all
                                        Testing Entities.
                                       Testing Documentation
                                        Requirements.
                                       Definitions.
                                       Test Case Specification Standard.
                                       Next Generation Desktop (NGD)
                                        Requirements.

[[Page 28074]]

 
                                    Shared System Maintainer and Part A/
                                     Part B (A/B)/Durable Medical
                                     Equipment (DME) Medicare
                                     Administrative Contractor (MAC) and
                                     the Single Testing Contractor (STC)
                                     Responsibilities for Systems
                                     Releases.
------------------------------------------------------------------------
                Medicare Benefit Policy (CMS-Pub. 100-02)
------------------------------------------------------------------------
218...............................  Calendar Year (CY) 2016 Eligibility
                                     Changes to the End-Stage Renal
                                     Disease (ESRD) Prospective Payment
                                     System (PPS) Low-Volume Payment
                                     Adjustment (LVPA).
                                    ESRD PPS Case-Mix Adjustments.
219...............................  Calendar Year (CY) 2016 Eligibility
                                     Changes to the End-Stage Renal
                                     Disease (ESRD) Prospective Payment
                                     System (PPS) Low-Volume Payment
                                     Adjustment ESRD PPS Case-Mix
                                     Adjustments (LVPA).
220...............................  Rural Health Clinic and Federally
                                     Qualified Health Center--Medicare
                                     Benefit Policy Manual Update.
221...............................  Telehealth Services.
------------------------------------------------------------------------
       Medicare National Coverage Determination (CMS-Pub. 100-03)
------------------------------------------------------------------------
189...............................  Screening for Cervical Cancer With
                                     Human Papillomavirus (HPV) Testing-
                                     National Coverage Determination
                                     (NCD).
190...............................  Screening for the Human
                                     Immunodeficiency Virus (HIV)
                                     Infection.
------------------------------------------------------------------------
              Medicare Claims Processing (CMS-Pub. 100-04)
------------------------------------------------------------------------
3436..............................  National Coverage Determination
                                     (NCD) for Screening for Colorectal
                                     Cancer Using CologuardTM--A
                                     Multitarget Stool DNA Test.
3437..............................  January 2016 Integrated Outpatient
                                     Code Editor (I/OCE) Specifications
                                     Version 17.0.
3438..............................  Emergency Update to the CY 2016
                                     Medicare Physician Fee Schedule
                                     Database (MPFSDB).
3439..............................  Healthcare Common Procedure Coding
                                     System (HCPCS) Codes Subject to and
                                     Excluded from Clinical Laboratory
                                     Improvement Amendments (CLIA)
                                     Edits.
3440..............................  New Waived Tests.
3441..............................  Update to Pub. 100-04, Chapter 02
                                     Admission and Registration
                                     Requirements, for Provider
                                     Verification of Beneficiary
                                     Eligibility and Entitlement.
                                       Purpose of Chapter.
                                       Definition of Provider and
                                        Supplier.
                                       General Admission and
                                        Registration Rules.
                                       Changes to HICNs.
                                       Contractor Procedures for
                                        Obtaining Missing or Incorrect
                                        Claim Numbers.
                                    Prohibition Against Waiver of Health
                                     Insurance Benefits as a Condition
                                     of Admission.
                                    Hospital and Skilled Nursing
                                     Facility (SNF) Verification of
                                     Prior Hospital Stay.
                                    Information for Determining
                                     Deductible and Benefit Period
                                     Status.
                                    A/B MAC (A) or (HHH) Requests to
                                     Verify Patient's HICN.
                                    B MAC (A) or (HHH) Learns
                                     Beneficiary is an HMO Enrollee.
                                    Retroactive Entitlement.
                                    2/30/Provider/Supplier Obtaining/
                                     Verifying the HICN and Entitlement
                                     Status.
                                    2/30.1/Cross-Reference of HICN.
                                    Health Insurance (HI) Card.
                                    Temporary Eligibility Notice.
                                    Reserved.
                                    Part A Inquiry (HIQA) Screen
                                     Display.
                                    Part A Inquiry Reply (HUQAR) Data.
                                    Health Insurance Query for Home
                                     Health Agencies (HIQH).
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                    HMO-Related Master File Corrections.
                                    Provider Problems Obtaining
                                     Entitlement Information.
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                    SSO Assistance in Resolving
                                     Entitlement Status Problems.
                                       Reserved.

[[Page 28075]]

 
                                       Reserved.
                                       Reserved.
                                       Reserved.
                                       Reserved.
3442..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
3443..............................  Manual Update to Pub. 100-04,
                                     Chapter 20, to Include Used Rental
                                     Equipment.
3444..............................  Payment for Purchased Durable
                                     Medical Equipment, Prosthetics,
                                     Orthotics, and Supplies (DMEPOS)
                                     Furnished to Medicare Beneficiaries
                                     Residing Outside the U.S.--
                                     Expatriate Beneficiaries.
3445..............................  Off-Cycle Update to the Long Term
                                     Care Hospital (LTCH) Prospective
                                     Payment System (PPS) Fiscal Year
                                     (FY) 2016 Pricer Budget Neutrality
                                     Offset.
3446..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
3447..............................  New Physician Specialty Code for
                                     Dentist Physician Specialty Codes.
3448..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
3449..............................  Off-Cycle Update to the Inpatient
                                     Prospective Payment System (IPPS)
                                     Fiscal Year (FY) 2016 Pricer.
3450..............................  April 2016 Quarterly Average Sales
                                     Price (ASP) Medicare Part B Drug
                                     Pricing Files and Revisions to
                                     Prior Quarterly Pricing Files.
3451..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
3452..............................  Additional Fields Added to the
                                     Outlier Reconciliation Lump Sum
                                     Utility Procedure for Medicare
                                     Contractors to Perform and Record
                                     Outlier Reconciliation Adjustments.
3453..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
3454..............................  Correction to Applying Therapy Caps
                                     to Maryland Hospitals and Billing
                                     Requirement for Rehabilitation
                                     Agencies and Comprehensive
                                     Outpatient Rehabilitation
                                     Facilities (CORFs).
                                    Payments on the MPFS for Providers
                                     With Multiple Service Locations.
                                    Part B Outpatient Rehabilitation and
                                     Comprehensive Outpatient
                                     Rehabilitation Facility (CORF)
                                     Services--General.
3455..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
3456..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
3457..............................  New Condition Code for Reporting
                                     Home Health Episodes With No
                                     Skilled Visits.
3458..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
3459..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Sensitivity of Instruction.
3460..............................  Screening for Cervical Cancer With
                                     Human Papillomavirus (HPV).
                                       Testing--National Coverage
                                        Determination (NCD).
                                       Screening for Cervical Cancer
                                        with Human Palillomavirus
                                        Testing.
                                       Screening Pap Smears: Healthcare
                                        Common Procedure Coding.
                                       System (HCPCS) Codes for Billing.
                                       Screening Pap Smears: Diagnoses
                                        Codes.
                                       TOB and Revenue Codes for Form
                                        CMS-1450.
                                       MSN Messages.
                                       Remittance Advice Codes.
3461..............................  Screening for the Human
                                     Immunodeficiency Virus (HIV)
                                     Infection.
                                    Healthcare Common Procedure Coding
                                     System (HCPCS) for HIV Screening
                                     Tests.
                                       Billing Requirements.
                                       Payment Method.
                                       Types of Bill (TOBs) and Revenue
                                        Code.
                                       Diagnosis Code Reporting.
                                    Medicare Summary Notice (MSN) and
                                     Claim Adjustment Reason Codes
                                     (CARCs).
3462..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
3463..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Sensitivity of Instruction.
3464..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
3465..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Sensitivity of Instruction.
3466..............................  Common Edits and Enhancements
                                     Modules (CEM) Code Set Update.
3467..............................  Healthcare Provider Taxonomy Codes
                                     (HPTCs) April 2016 Code Set Update.
3468..............................  Medicare Internet Only Manual (IOM)
                                     Publication 100-04 Chapter 27
                                     Contractor Instructions for CWF.
3469..............................  Quarterly Update to the Medicare
                                     Physician Fee Schedule Database
                                     (MPFSDB)--April CY 2016 Update.
3470..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
3471..............................  April 2016 Update of the Hospital
                                     Outpatient Prospective Payment
                                     System (OPPS).
3472..............................  Billing Instructions for IMRT
                                     Planning Billing for Multi-Source
                                     Photon (Cobalt 60-Based)
                                     Stereotactic Radiosurgery (SRS)
                                     Planning and Delivery.
3473..............................  July Quarterly Update to 2016 Annual
                                     Update of HCPCS Codes Used for
                                     Skilled Nursing Facility (SNF)
                                     Consolidated Billing (CB)
                                     Enforcement.
3474..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
3475..............................  Updates to Pub. 100-04, Chapters 4
                                     and 5 to Correct Remittance Updates
                                     to Pub. 100-04, Chapters 4 and 5 to
                                     Correct Remittance.
                                       Advice Messages.
                                       Remittance Advice Coding Used in
                                        this Manual.
                                    Editing Of Hospital Part B Inpatient
                                     Services: Reasonable and Necessary
                                     Part A Hospital Inpatient Denials.
                                    Editing Of Hospital Part B Inpatient
                                     Services: Other Circumstances in
                                     Which Payment Cannot Be Made under
                                     Part A.
                                    Assistant at Surgery Medicare
                                     Summary Notice (MSN) and Remittance
                                     Advice (RA) Messages.
                                    Co-surgeon Services Medicare Summary
                                     Notice (MSN) and Remittance Advice
                                     (RA) Messages.
                                    Codes.
                                    Claims Processing Requirements for
                                     Financial Limitations/Multiple
                                     Procedure Payment Reductions for
                                     Outpatient Rehabilitation Services.

[[Page 28076]]

 
                                    Coding Guidance for Certain CPT
                                     Codes--All Claim Advice Messages.
3476..............................  Telehealth Services.
                                       List of Medicare Telehealth
                                        Services.
                                       Payment for ESRD-Related Services
                                        as a Telehealth Service.
                                       Payment for Subsequent Hospital
                                        Care Services and Subsequent
                                        Nursing Facility Care Services
                                        as Telehealth Services.
                                       Payment for Diabetes Self-
                                        Management Training (DSMT) as a
                                        Telehealth Service.
                                       Originating Site Facility Fee
                                        Payment Methodology.
                                       Payment Methodology for Physician/
                                        Practitioner at the Distant
                                        Site.
                                       Submission of Telehealth Claims
                                        for Distant Site Practitioners.
3477..............................  April 2016 Integrated Outpatient
                                     Code Editor (I/OCE) Specifications
                                     Version 17.1.
3478..............................  April 2016 Update of the Ambulatory
                                     Surgical Center (ASC) Payment
                                     System.
3479..............................  New Waived Test.
3480..............................  Instructions for Downloading the
                                     Medicare ZIP Code File for July
                                     2016.
3481..............................  Updates to Pub. 100-04, Chapters 3,
                                     6, 7 and 15 to Correct Remittance
                                     Advice Messages.
                                       Payment for Blood Clotting Factor
                                        Administered to Hemophilia.
                                       Inpatients.
                                       Pancreas Transplants Kidney
                                        Transplants.
                                       Pancreas Transplants Alone (PA).
                                       Intestinal and Multi-Visceral
                                        Transplants.
                                       Billing for Abortion Services.
                                       Remittance Advices.
                                       Remittance Advice Impact.
                                       Recording Determinations of
                                        Excepted/Nonexcepted Care on
                                        Claim Records.
                                       Reject and Unsolicited Response
                                        Edits.
                                       Edit for Clinical Social Workers
                                        (CSWs).
                                       Editing of Skilled Nursing
                                        Facilities Part B Inpatient
                                        Services.
                                       Additional Introductory
                                        Guidelines.
                                       ZIP Code Determines Fee Schedule
                                        Amounts.
                                       Coding Instructions for Paper and
                                        Electronic Claim Forms.
3482..............................  Quarterly Update to the Correct
                                     Coding Initiative (CCI) Edits,
                                     Version 22.2, Effective July 1,
                                     2016.
3483..............................  April 2016 Integrated Outpatient
                                     Code Editor (I/OCE) Specifications
                                     Version 17.1.
3484..............................  Medicare Internet Only Manual
                                     Publication 100-04 Chapter 26--
                                     Completing and Processing Form CMS-
                                     1500 Data Set.
3485..............................  Changes to the Laboratory National
                                     Coverage Determination (NCD) Edit
                                     Software for July 2016.
3486..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
3487..............................  Corrections to Recoding in the Home
                                     Health (HH) Pricer Program.
3488..............................  Quarterly Update for the Durable
                                     Medical Equipment, Prosthetics,
                                     Orthotics and Supplies (DMEPOS)
                                     Competitive Bidding Program (CBP)--
                                     July 2016.
------------------------------------------------------------------------
               Medicare Secondary Payer (CMS-Pub. 100-05)
------------------------------------------------------------------------
00................................  None.
------------------------------------------------------------------------
             Medicare Financial Management (CMS-Pub. 100-06)
------------------------------------------------------------------------
258...............................  Notice of New Interest Rate for
                                     Medicare Overpayments and
                                     Underpayments 2nd Qtr Notification
                                     for FY 2016.
259...............................  Internet Only Manual Pub. 100-06,
                                     Chapter 4 Revisions to Reflect the
                                     New Debt Referral Requirements
                                     Mandated by the Digital
                                     Accountability and Transparency Act
                                     of 2014 (DATA Act).
                                    Requirements for Collecting Part A
                                     and B Non-MSP Provider
                                     Overpayments.
                                    Required Timeframes for Debt
                                     Collection Process for Provider Non-
                                     MSP Overpayments.
                                    Referral Requirements.
                                    Debts RTA by Treasury as paid in
                                     Full (RP), Satisfied Payment
                                     Agreement (RS) or Satisfied
                                     Compromise (RC)--Exhibit 1 Intent
                                     to Refer Letter (IRL).
260...............................  Revision to Chapter 3 Section 200:
                                     Limitation on Recoupment--Medicare
                                     Overpayments Manual.
261...............................  Monitoring Accounts Receivable that
                                     are in a Redetermination or
                                     Reconsideration Status.
262...............................  New Physician Specialty Code for
                                     Dentist Physician/Limited License
                                     Physician Specialty Codes.
263...............................  Contractor Reporting of Operational
                                     and Workload Data (CROWD) Form 5.
                                    Update with Revisions to Pub. 100-06
                                     Medicare Financial Management
                                     Manual, Chapter 6.
264...............................  Extended Repayment Schedule (ERS)
                                     Manual Updates.
                                    Establishing an Extended Repayment
                                     Schedule (ERS)--(formerly known as
                                     an Extended Repayment Plan (ERP).
                                    ERS Required Documentation--
                                     Physician is a Sole Proprietor.
                                    ERS Required Documentation--Provider
                                     is an Entity Other Than a Sole
                                     Proprietor.
265...............................  Contractor Reporting of Operational
                                     and Workload Data (CROWD) Form 5.
                                       Update with Revisions to Pub. 100-
                                        06 Medicare Financial Management
                                        Manual, Chapter 6.
                                       Medicare Contractor Transaction
                                        Report (CROWD Form 5).
                                       Heading.
                                       Body of Report.
------------------------------------------------------------------------
           Medicare State Operations Manual (CMS-Pub. 100-07)
------------------------------------------------------------------------
152...............................  Revisions to the State Operations
                                     Manual (SOM) Chapter 2 Numbering
                                     System for CMS Certification
                                     Numbers (CCN).

[[Page 28077]]

 
                                    CCN for Medicare Providers.
153...............................  Revisions to the State Operations
                                     Manual (SOM) Chapter 9 Exhibits.
------------------------------------------------------------------------
              Medicare Program Integrity (CMS-Pub. 100-08)
------------------------------------------------------------------------
635...............................  Clarification to Language Regarding
                                     Proof of Delivery Requirements in
                                     Pub. 100-08, Chapter 4, Section
                                     4.26.1.
                                       Proof of Delivery and Delivery
                                        Methods.
636...............................  Update to Pub. 100-08, Chapter 15.
                                       Medicare Contractor Duties.
                                       Correspondence Address and E-mail
                                        Addresses.
                                       Tax Identification Numbers (TINs)
                                        of Owning and Managing.
                                       Organizations and Individuals.
                                       Form CMS-855A and Form CMS-855B
                                        Signatories.
                                       Delegated Officials.
                                       Technicians.
                                       Supervising Physicians.
                                       Processing Form CMS-855R
                                        Applications.
                                       Inter-Jurisdictional
                                        Reassignments.
                                       Form CMS-855 Applications That
                                        Require a Site Visit.
                                       Form CMS-855 Applications That Do
                                        Not Require a Site Visit.
                                       General Timeliness Principles.
                                       Receipt/Review of Internet-Based
                                        PECOS Applications.
                                       Verification of Data/Processing
                                        Alternatives.
                                       Special Program Integrity
                                        Procedures.
                                       Tie-In/Tie-Out Notices and
                                        Referrals to the State/RO.
                                       Ambulatory Surgical Centers
                                        (ASCs)/Portable X-ray Suppliers
                                        (PXRS).
                                    Tie-In/Tie-Out Notices and Referrals
                                     to the State/RO.
                                       Processing of Registration
                                        Applications.
                                       Disposition of Registration
                                        Applications.
                                       Revocation of Registration.
                                       Registration Letters.
                                       Returns.
                                       Denials.
                                       Non-Certified Suppliers and
                                        Individual Practitioners.
                                       Existing or Delinquent
                                        Overpayments.
                                       Contractor Communications.
                                       Application Fees.
                                       Movement of Providers and
                                        Suppliers into the High Level.
                                       Web Sites.
                                    Release of Information.
                                       Model Letter Guidance.
                                       Approval Letter Guidance.
                                       Appeals Process.
                                       Corrective Action Plans (CAPs).
                                       Reconsideration Requests--Non-
                                        Certified Providers/Suppliers.
                                       Corrective Action Plans (CAPs).
                                       Reconsideration Requests--
                                        Certified Providers and
                                        Certified Suppliers.
                                       HHA Ownership Chang.
                                       Revocations.
                                       Other Identified Revocations.
                                       External Reporting Requirements.
                                       Reserved for Future Use.
637...............................  Comprehensive Error Rate Testing
                                     (CERT) program Treatment of Claims
                                     in the Prior Authorization Model.
638...............................  Issued to a specific audience, not
                                     posted to Internet/Intranet to
                                     Confidentiality of Instruction.
639...............................  Issued to a specific audience, not
                                     posted to Internet/Intranet to
                                     Confidentiality of Instruction.
640...............................  Issued to a specific audience, not
                                     posted to Internet/Intranet to
                                     Confidentiality of Instruction.
641...............................  Proof of Delivery in Nursing
                                     Facilities.
642...............................  Medicare Program Integrity Changes--
                                     Pub. 100-08 Chapter 7.
------------------------------------------------------------------------
  Medicare Contractor Beneficiary and Provider Communications (CMS-Pub.
                                 100-09)
------------------------------------------------------------------------
                                    None.
------------------------------------------------------------------------
       Medicare Quality Improvement Organization (CMS-Pub. 100-10)
------------------------------------------------------------------------
                                    None.
------------------------------------------------------------------------
Medicare End Stage Renal Disease Network Organizations (CMS Pub. 100-14)
------------------------------------------------------------------------
                                    None.
------------------------------------------------------------------------

[[Page 28078]]

 
 Medicaid Program Integrity Disease Network Organizations (CMS Pub. 100-
                                   15)
------------------------------------------------------------------------
                                    None.
------------------------------------------------------------------------
                 Medicare Managed Care (CMS-Pub. 100-16)
------------------------------------------------------------------------
                                    None.
------------------------------------------------------------------------
      Medicare Business Partners Systems Security (CMS-Pub. 100-17)
------------------------------------------------------------------------
                                    None.
------------------------------------------------------------------------
                    Demonstrations (CMS-Pub. 100-19)
------------------------------------------------------------------------
133...............................  Issued to a specific audience, not
                                     posted to Internet/Intranet to
                                     Confidentiality of Instruction.
134...............................  Medicare Care Choices Model (MCCM)--
                                     Per Beneficiary per Month Payment
                                     (PBPM)--Implementation.
135...............................  Affordable Care Act Bundled Payments
                                     for Care Improvement Initiative--
                                     Recurring File Updates Models 2 and
                                     4 April 2016 Updates.
136...............................  Issued to a specific audience, not
                                     posted to Internet/Intranet to
                                     Confidentiality of Instruction.
137...............................  Implementation of the Part B Drug
                                     Payment Model (Phase 1).
138...............................  Issued to a specific audience, not
                                     posted to Internet/Intranet to
                                     Confidentiality of Instruction.
139...............................  Oncology Care Model (OCM) Monthly
                                     Enhanced Oncology Services (MEOS)
                                     Payment Implementation.
140...............................  Comprehensive Care for Joint
                                     Replacement Model (CJR) Provider
                                     Education.
141...............................  Medicare Care Choices Model (MCCM)--
                                     Per Beneficiary per Month Payment
                                     (PBPM)--Implementation.
------------------------------------------------------------------------
                 One Time Notification (CMS-Pub. 100-20)
------------------------------------------------------------------------
1590..............................  Implementation of Procedures for
                                     Undeliverable Medicare Summary
                                     Notices (uMSNs).
1591..............................  Changes to the Medicare Electronic
                                     Health Record (EHR) Incentive
                                     Program Payment Adjustment
                                     beginning January 1, 2016.
1592..............................  Award of Durable Medical Equipment
                                     (DME) Medicare Administrative
                                     Contractor (MAC) Contract for
                                     Jurisdiction D.
1593..............................  Health Insurance Portability and
                                     Accountability Act (HIPAA) EDI
                                     Front End Updates for July 2016.
1594..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Sensitivity of Instruction.
1595..............................  Issuing Continuing Compliance
                                     Letters to Specific Providers and
                                     Suppliers.
1596..............................  Required Billing Updates for Rural
                                     Health Clinics.
1597..............................  System Specific Enhancement 2014:
                                     Create A Single Trailer-Generating
                                     Module in Common Working File
                                     (CWF).
1598..............................  Shared System Enhancement 2015
                                     Resolve Operating Report (ORPT)
                                     Issues, Analysis and Design.
1599..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Sensitivity of Instruction.
1600..............................  Award of Medicare Administrative
                                     Contractor (MAC) Contract for
                                     Jurisdiction 15.
1601..............................  Payment Clarification for the
                                     Purchase of Used Inexpensive and
                                     Routinely Purchased Durable Medical
                                     Equipment (DME) when Previously
                                     Rented.
1602..............................  Part B Detail Line Expansion--MCS
                                     Phase 4.
1603..............................  Part B Detail Line Expansion--MCS
                                     Phase.
1604..............................  Part B Detail Line Expansion--MCS
                                     Phase 1.
1605..............................  Common Working File (CWF) Daily
                                     Beneficiary Extract Files Reaching
                                     Maximum Record Size, Analysis and
                                     Design for Possible Data
                                     Reorganization.
1606..............................  Shared System Enhancement 2015 Edit
                                     Control/Override Table, Analysis
                                     and Design.
1607..............................  Shared System Enhancement 2015
                                     Improve Efficiency of Drug Code
                                     Provider, and Procedure and
                                     Diagnosis Codes Processing,
                                     Analysis and Design.
1608..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Sensitivity of Instruction.
1609..............................  Accredited Standards Committee (ASC)
                                     X12 Healthcare Claims
                                     Acknowledgement (277CA) Flat File
                                     Update.
1610..............................  System Specific Enhancement 2014:
                                     Fiscal Intermediary Standard System
                                     (FISS) Edit/Rules Engine Analysis
                                     and Design.
1611..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Sensitivity of Instruction.
1612..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Sensitivity of Instruction.
1613..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Sensitivity of Instruction.
1614..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Sensitivity of Instruction.
1615..............................  Advance Care Planning (ACP) Services
                                     furnished by Rural Health Clinics
                                     (RHCs).
1616..............................  Updating the Fiscal Intermediary
                                     Shared System (FISS) to Make
                                     Payment for Drugs and Biologicals
                                     Services for Outpatient Prospective
                                     Payment System (OPPS) Providers.
1617..............................  System Specific Enhancement 2014:
                                     String Testing Automation.
1618..............................  System Specific Enhancement 2015:
                                     Replace FISS ACS/Development
                                     Letters with HP Exstream, Analysis
                                     Only.
1619..............................  Revision to Fiscal Intermediary
                                     Shared System (FISS) Lab Travel
                                     Allowance Editing to Include New
                                     Specimen Collection Code G0471.
1620..............................  Shared System Enhancement 2015:
                                     National Coverage Determination
                                     (NCD) Analysis Process.
1621..............................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     Confidentiality of Instruction.
1622..............................  Shared System Enhancement 2015
                                     Analysis and Design HUOPCUT Hospice
                                     Period and Health Maintenance
                                     Organization (HMO) Processing.
1623..............................  Using scrubbed Medicare beneficiary/
                                     legal rep address data within the
                                     Fee-For-Service (FFS) systems--
                                     Analysis and Design.

[[Page 28079]]

 
1624..............................  System Specific Enhancement 2015:
                                     Fiscal Intermediary Standard System
                                     (FISS) Enhanced Purge Process.
1625..............................  Identifying ``No Documentation''
                                     Medical Necessity Denials for
                                     Claims Flagged for Recovery Auditor
                                     Review.
1626..............................  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.
1627..............................  Durable Medical Equipment,
                                     Prosthetics, Orthotics and Supplies
                                     (DMEPOS) Competitive Bidding
                                     Program (CBP): Implementation of
                                     Round 2 Recompete of the DMEPOS CBP
                                     Program and National Mail Order
                                     (NMO) Recompete.
1628..............................  Identification of Obsolete Shared
                                     System Maintainer (SSM) On-Request
                                     Jobs--VMS.
1629..............................  Identification of Obsolete Shared
                                     System Maintainer (SSM) Reports--
                                     VMS.
1630..............................  Coding Revisions to National
                                     Coverage Determinations.
1631..............................  Shared System Enhancement 2015 Edit
                                     Control/Override Table, Analysis
                                     and Design.
1632..............................  Shared System Enhancement 2015
                                     Resolve Operating Report (ORPT)
                                     Issues, Analysis and Design.
1633..............................  Settlement Effectuation Instructions
                                     for the Department of Health and
                                     Human Services' (DHHS) Office of
                                     Medicare Hearings and Appeals
                                     (OMHA) Settlement Conference
                                     Facilitation (SCF) Pilot Related to
                                     Part A Appeals (Phase 3).
1634..............................  Implementation of the Award for
                                     Jurisdiction A Durable Medical
                                     Equipment (DME) Medicare
                                     Administrative Contractor (MAC)
                                     Workload.
1635..............................  VIPS Medicare System (VMS), Analysis
                                     and Design for Jurisdiction A (JA)
                                     and Jurisdiction B (JB) Durable
                                     Medical Equipment (DME) Medicare
                                     Administrative Contractors (MACs)
                                     Transitions.
1636..............................  Implementation of the Award for
                                     Jurisdiction B Durable Medical
                                     Equipment (DME) Medicare
                                     Administrative Contractor (MAC)
                                     Workload.
1637..............................  Required Billing Updates for Rural
                                     Health Clinics.
1638..............................  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.
1639..............................  Reporting Principal and Interest
                                     Amounts When Refunding Previously
                                     Recouped Money on the Remittance
                                     Advice (RA).
1640..............................  End Stage Renal Disease (ESRD) Cost
                                     Audits.
------------------------------------------------------------------------
     Medicare Quality Reporting Incentive Programs (CMS-Pub. 100-22)
------------------------------------------------------------------------
53................................  Issued to a specific audience, not
                                     posted to Internet/Intranet due to
                                     a Confidentiality of Instruction.
54................................  Fiscal Year 2017 and After Payments
                                     to Inpatient Rehabilitation
                                     Facilities (IRFs) That Do Not
                                     Submit Required Quality Data--This
                                     CR Rescinds and Fully Replaces CR
                                     9106.
55................................  Fiscal Year 2017 and After Payments
                                     to IRFs That Do Not Submit Required
                                     Quality Data.
------------------------------------------------------------------------
    Information Security Acceptable Risk Safeguards (CMS-Pub. 100-25)
------------------------------------------------------------------------
                                    None.
------------------------------------------------------------------------

Addendum II: Regulation Documents Published in the Federal Register 
(January through March 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 Web site http://www.archives.gov/federal-register/ provides 
information on how to access electronic editions, printed editions, and 
reference copies.
    This information is available on our Web site at: http://www.cms.gov/quarterlyproviderupdates/downloads/Regs-1Q16QPU.pdf
    For questions or additional information, contact Terri Plumb (410-
786-4481).

Addendum III: CMS Rulings (January through March 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 http://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings. For questions or additional information, 
contact Tiffany Lafferty (410-786-7548).

Addendum IV: Medicare National Coverage Determinations (January through 
March 2016)

    Addendum IV includes completed national coverage determinations 
(NCDs), or reconsiderations of completed NCDs, from the quarter covered 
by this notice. Completed decisions are identified by the section of 
the NCD Manual (NCDM) in which the decision appears, the title, the 
date the publication was issued, and the effective date of the 
decision. An NCD is a determination by the Secretary for whether or not 
a particular item or service is covered nationally under the Medicare 
Program (title XVIII of the Act), but does not include a determination 
of the code, if any, that is assigned to a particular covered item or 
service, or payment determination for a particular covered item or 
service. The entries below include information

[[Page 28080]]

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 Web site. 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: www.cms.gov/medicare-coverage-database/. For questions or additional information, contact 
Wanda Belle (410-786-7491).

----------------------------------------------------------------------------------------------------------------
                                                                    Transmittal
                 Title                        NCDM section            number        Issue date    Effective date
----------------------------------------------------------------------------------------------------------------
Screening for the Human                 NCD 210.7...............            R190      02/05/2016      04/13/2015
 Immunodeficiency Virus (HIV)
 Infection.
Screening for Cervical Cancer With      NCD 210.2.1.............            R189      02/02/2016      07/09/2015
 Human Papillomavirus (HPV) Testing--
 National Coverage Determination (NCD).
----------------------------------------------------------------------------------------------------------------

Addendum V: FDA-Approved Category B Investigational Device Exemptions 
(IDEs) (January through March 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 number. 
For the purposes of this quarterly notice, we list only the specific 
updates to the Category B IDEs as of the ending date of the period 
covered by this notice and a contact person for questions or additional 
information. For questions or additional information, contact John 
Manlove (410-786-6877).
    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 information about the classes or categories, please refer 
to the notice published in the April 21, 1997 Federal Register (62 FR 
19328).

------------------------------------------------------------------------
              IDE                         Device            Start date
------------------------------------------------------------------------
BB16806........................  MarrowStim P.A.D. Kit:       01/22/2016
                                  Concentration of
                                  autologous bone marrow
                                  aspirate (cBMA).
G130034........................  BIOFREEDOM Drug Coated       02/10/2016
                                  Coronary Stent System.
G150002........................  Silhouette Instalift...      01/08/2016
G150154........................  RA-308 Excimer Laser         01/08/2016
                                  System and DABRA
                                  Catheter Model 101.
G150269........................  Sodium Hyaluronate (1%)      01/06/2016
                                  Ophthalmic Viscoelastc
                                  Devices (OVD), Sodium
                                  Hyaluronate (2.3%)
                                  Ophthalmic
                                  Viscoelastic Devices
                                  (OVD).
G150270........................  Embozene Microspheres..      01/08/2016
G150273........................  Medtronic Activa PC+S        01/15/2016
                                  Deep Brain Stimulation
                                  System.
G150275........................  Optune (Novocure's           03/24/2016
                                  Tumor Treating
                                  Electric Fields
                                  [TTFIELDS] Therapy).
G150278........................  SAPIEN 3 Transcatheter       01/14/2016
                                  Heart Valve and
                                  Accessories.
G150282........................  Berlin Heart EXCOR           01/28/2016
                                  Pediatric Ventricular
                                  Assist Device.
G160002........................  FlowTriever Retrieval/       02/03/2016
                                  Aspiration System.
G160004........................  Embosphere Microspheres      02/04/2016
G160008........................  Investigational LabCorp      02/10/2016
                                  MGMT Methylation-
                                  Specific PCR Companion
                                  DIagnostic Assay.
G160009........................  Medtronic PC+S Deep          02/11/2016
                                  Brain Stimulation
                                  system.
G160011........................  CP950 Sound Processor        02/17/2016
                                  (Kanso).
G160015........................  JetStream (Boston            02/19/2016
                                  Scientific)
                                  Atherectomy.
G160018........................  Deep brain stimulation       03/23/2016
                                  (DBS) in patients with
                                  refractory chronic
                                  neuropathic pain.
G160019........................  CT-DBS for Traumatic         02/26/2016
                                  Brain Injury using the
                                  Medtronic Activa PC+S
                                  System.
G160021........................  A Feasibility Study to       03/02/2016
                                  Evaluate Safety and
                                  Initial Effectiveness
                                  of MR-Guided Focused
                                  Ultrasound Ablation
                                  Therapy in the
                                  Treatment of
                                  Subcortical Lesional
                                  Epilepsy.
G160022........................  CoreValve Evolut R           02/17/2016
                                  System, Medtronic
                                  CoreValve System.
G160023........................  NeuroStar TMS Therapy        03/04/2016
                                  System with the
                                  NeuroStar XPLOR
                                  Clinical Research
                                  System.
G160025........................  Medtronic DBS Lead           03/04/2016
                                  Model 3387.
G160028........................  NeuroBlate System......      03/09/2016
G160029........................  VENTANA HA CDx Assay...      03/10/2016
G160033........................  Veterans Administration      03/09/2016
                                  Lung Cancer Surgery or
                                  Stereotactic
                                  Radiotherapy (VALOR).
G160035........................  Misago RX Self-              03/17/2016
                                  expanding Peripheral
                                  Stent.
G160038........................  MYELOTEC VIDEO GUIDED        03/17/2016
                                  CATHETER; MYELOTEC
                                  MYELOSCOPE.
G160039........................  Medtronic TAVR 2.0           03/16/2016
                                  System.
G160041........................  The Ulthera System; DS       03/18/2016
                                  4-4.5S, Simulines
                                  Transducer;DS 4-3.0S,
                                  Simulines Transducer;
                                  DS 4-4.5, Standard
                                  Transducer; DS 7-3.0,
                                  Standard Transducer.
G160042........................  LUMENATI SYSTEM........      03/18/2016
G160043........................  Senza Spinal Cord            03/23/2016
                                  Stimulation (SCS)
                                  System.
G160045........................  NeuroStar TMS Therapy        03/24/2016
                                  System with the
                                  NeuroStar XPLOR
                                  Clinical Research
                                  System.
------------------------------------------------------------------------


[[Page 28081]]

Addendum VI: Approval Numbers for Collections of Information (January 
through March 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).

Addendum VII: Medicare-Approved Carotid Stent Facilities, (October 
through December 2015)

    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: 
http://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage 
For questions or additional information, contact Lori Ashby (410-786-
6322).

----------------------------------------------------------------------------------------------------------------
                   Facility                      Provider No.   Effective date                State
----------------------------------------------------------------------------------------------------------------
                           The following facilities are new listings for this quarter
----------------------------------------------------------------------------------------------------------------
Community Medical Center Barnabas Health, 99            310041      01/07/2016  NJ.
 Highway 37 West Toms River, NJ 08755.
Las Palmas Medical Center, 1801 North Oregon,       1770536120      01/07/2016  TX.
 El Paso, TX 79902.
Sky Ridge Medical Center, 10101 Ridgegate               060112      01/04/2016  CO.
 Parkway, Lone Tree, CO 80124.
McLaren Port Huron, 1221 Pine Grove Port,           1982685384      01/04/2016  MI.
 Huron, MI 48061.
DMC Huron Valley--Sinai Hospital, 1 Williams        1922310200      01/04/2016  MI.
 Carls Drive, Commerce, MI 48382.
Valley Baptist Medical Center--Brownsville, PO          450028      03/09/2016  TX.
 Box 450028, 1040 West Jefferson, Brownsville,
 TX 78520.
Manchester Memorial Hospital, 71 Haynes             1457399198      03/09/2016  CT.
 Street, Manchester, CT 06040.
Grand Stand Medical Center, 809 82nd Parkway,       1083668669      03/23/2016  SC.
 Myrtle Beach, SC 29572.
Ben Taub Hospital, 1504 Taub Loop, Houston, TX          450289      03/30/2016  TX.
 77030.
----------------------------------------------------------------------------------------------------------------
                            The following facilities have editorial changes (in bold)
----------------------------------------------------------------------------------------------------------------
FROM: Saint Joseph Medical Center, TO: St.              390096      04/01/2005  PA.
 Joseph Medical Center, 2500 Bernville Road,
 Reading, PA 19605.
FROM: Helen Ellis Memorial Hospital, TO:                100055      01/20/2009  FL.
 Florida Hospital North Pinellas, 1395 South
 Pinellas Avenue, Tarpon Springs, FL 34689.
----------------------------------------------------------------------------------------------------------------
                 The following facility has been removed from the listing of approved facilities
----------------------------------------------------------------------------------------------------------------
Rockingham Memorial Hospital, 235 Cantrell              490004      06/30/2010  VA.
 Avenue, Harrisonburg, VA 22801.
----------------------------------------------------------------------------------------------------------------

Addendum VIII: American College of Cardiology's National Cardiovascular 
Data Registry Sites (January through March 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 ICD 
Abstraction Tool through the Quality Network Exchange (QNet) as a 
temporary data collection mechanism. On October 27, 2005, CMS announced 
that the American College of Cardiology's National Cardiovascular Data 
Registry (ACC-NCDR) ICD Registry satisfies the data reporting 
requirements in the NCD. Hospitals needed to transition to the ACC-NCDR 
ICD Registry by April 2006.
    Effective January 27, 2005, to obtain reimbursement, Medicare NCD 
policy requires that providers implanting ICDs for primary prevention 
clinical indications (that is, patients without a history of cardiac 
arrest or spontaneous arrhythmia) report data on each primary 
prevention ICD procedure. Details of the clinical indications that are 
covered by Medicare and their respective data reporting requirements 
are available in the Medicare NCD Manual, which is on the CMS Web site 
at http://www.cms.hhs.gov/Manuals/IOM/itemdetail.asp?filterType=none&filterByDID=99&sortByDID=1&sortOrder=ascending&itemID=CMS014961
    A provider can use either of two mechanisms to satisfy the data 
reporting requirement. Patients may be enrolled either in an 
Investigational Device Exemption trial studying ICDs as identified by 
the FDA or in the ACC-NCDR ICD registry. Therefore, for a beneficiary 
to receive a Medicare-covered ICD implantation for primary prevention, 
the beneficiary must receive the scan in a facility that participates 
in the ACC-NCDR ICD registry. The entire list of facilities that 
participate in the ACC-NCDR ICD registry can be found at www.ncdr.com/webncdr/common
    For the purposes of this quarterly notice, we are providing only 
the specific updates that have occurred in the 3-month period. This 
information is available by accessing our Web site 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 Marie Casey, BSN, MPH (410-786-7861).

[[Page 28082]]



------------------------------------------------------------------------
             Facility                    City               State
------------------------------------------------------------------------
       The following facilities are new listings for this quarter
------------------------------------------------------------------------
Saint Francis Hospital............        Columbus  GA.
CGH Medical Center................        Sterling  IL.
Longmont United Hospital..........        Longmont  CO.
La Paz Regional Hospital..........          Parker  AZ.
Carlsbad Medical Center...........        Carlsbad  NM.
Pacific Surgery Center............      Costa Mesa  CA.
Memorial Care Outpatient Surgical       Long Beach  CA.
 Center of Long Beach.
Pearland Medical Center (HCA).....        Pearland  TX.
Alaska Native Medical Ctr.........       Anchorage  AK.
Bronx-Lebannon Hospital Center....           Bronx  NY.
Kentuckiana Medical Center........     Clarksville  IN.
Wheaton Franciscan Healthcare--          Milwaukee  WI.
 Franklin, Inc.
Andalusia Regional Hospital.......       Andalusia  AL.
Parkway Surgical & Cardiovascular       Fort Worth  TX.
 Hospital.
Bay Area Regional Medical Center..         Webster  TX.
Sanford Bemidji Medical Center....         Bemidji  MN.
Flushing Hospital Medical Center..        Flushing  NY.
Garden Park Medical Center........        Gulfport  MS.
Silicon Valley Interventional              Houston  TX.
 Surgery Center.
Surgery Center of Enid, Inc.......            Enid  OK.
UPMC East.........................     Monroeville  PA.
Straith Hospital For Special            Southfield  MI.
 Surgery.
Bay Area Hospital.................        Coos Bay  OR.
Kaiser Permanente Irvine Medical            Irvine  CA.
 Center.
Cohen Children's Medical Center...   New Hyde Park  NY.
------------------------------------------------------------------------
                 The following facilities are terminated
------------------------------------------------------------------------
St. Elizabeth Healthcare Florence.        Florence  KY.
Lakewood Hospital.................        Lakewood  OH.
Mease Dunedin Hospital............         Dunedin  FL.
Baylor All Saints Medical Center..          Dallas  TX.
Regional Medical Center of               Lafayette  LA.
 Acadiana.
CHI Health St. Elizabeth..........         Lincoln  NE.
Ochsner North Shore Covington.....       Covington  LA.
Central Carolina (LifePoint)......         Sanford  NC.
Mohammed Bin Khalifa Cardiac                 Riffa  International.
 Centre.
Rockdale Medical Center...........         Conyers  GA.
------------------------------------------------------------------------

Addendum IX: Active CMS Coverage-Related Guidance Documents (January 
through March 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 http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=27. There are no 
additional Active CMS Coverage-Related Guidance Documents for the 3-
month period. For questions or additional information, contact JoAnna 
Baldwin (410-786-7205).

Addendum X: List of Special One-Time Notices Regarding National 
Coverage Provisions (January through March 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 (410-786 7205).

Addendum XI: National Oncologic PET Registry (NOPR) (January through 
March 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 http://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. For questions or 
additional information, contact Stuart Caplan, RN, MAS (410-786-8564).

[[Page 28083]]

Addendum XII: Medicare-Approved Ventricular Assist Device (Destination 
Therapy) Facilities (January through March 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 VADs 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.
    For the purposes of this quarterly notice, there were no specific 
updates that have occurred to the list of Medicare-approved facilities 
that meet our standards in the 3-month period. This information is 
available at http://www.cms.gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage. For questions or additional information, contact 
Marie Casey, BSN, MPH (410-786-7861).

Addendum XIII: Lung Volume Reduction Surgery (LVRS) (January through 
March 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 of Healthcare Organizations (JCAHO)) under 
their Disease Specific Certification Program for LVRS; and
     Medicare approved for lung transplants.
    Only the first two types are in the list. There were no updates to 
the listing of facilities for lung volume reduction surgery published 
in the 3-month period. This information is available at www.cms.gov/MedicareApprovedFacilitie/LVRS/list.asp#TopOfPage. For questions or 
additional information, contact Marie Casey, BSN, MPH (410-786-7861).

Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (January 
through March 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 Level 1 Bariatric Surgery 
Center (program standards and requirements in effect on February 15, 
2006); or (2) certified by the American Society for Bariatric Surgery 
(ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program 
standards and requirements in effect on February 15, 2006).
    There were no additions, deletions, or editorial changes to 
Medicare-approved facilities that meet CMS's minimum facility standards 
for bariatric surgery that have been certified by ACS and/or ASMBS in 
the 3-month period. This information is available at www.cms.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage. For questions or 
additional information, contact Sarah Fulton, MPH (410-786-2749).

Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases 
Clinical Trials (January through March 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 Web site at www.cms.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage. For questions or 
additional information, contact Stuart Caplan, RN, MAS (410-786-8564).

[FR Doc. 2016-10819 Filed 5-6-16; 8:45 am]
 BILLING CODE 4120-01-P