81 FR 28072 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2016

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

Federal Register Volume 81, Issue 89 (May 9, 2016)

Page Range		28072-28083
FR Document		2016-10819

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.

Federal Register, Volume 81 Issue 89 (Monday, May 9, 2016)

[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Notices]
[Pages 28072-28083]
From the Federal Register Online [www.thefederalregister.org]
[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.thefederalregister.org/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.thefederalregister.org/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

Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices 28075

Transmittal No. Manual/subject/publication No.

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) Fur-
nished 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 Deni-
mstockstill on DSK3G9T082PROD with NOTICES

als.
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 Out-
patient Rehabilitation Services.

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Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices 28077

Transmittal No. Manual/subject/publication No.

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.
mstockstill on DSK3G9T082PROD with NOTICES

Medicare Quality Improvement Organization (CMS-Pub. 100–10)

......................................................... None.

Medicare End Stage Renal Disease Network Organizations (CMS Pub. 100–14)

......................................................... None.

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28078 Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices

Transmittal No. Manual/subject/publication No.

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 begin-
ning January 1, 2016.
1592 ................................................ Award of Durable Medical Equipment (DME) Medicare Administrative Contractor (MAC) Contract for Juris-
diction 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 Diag-
nosis 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 Up-
date.
1610 ................................................ System Specific Enhancement 2014: Fiscal Intermediary Standard System (FISS) Edit/Rules Engine Anal-
ysis 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 Serv-
ices 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.
mstockstill on DSK3G9T082PROD with NOTICES

1619 ................................................ Revision to Fiscal Intermediary Shared System (FISS) Lab Travel Allowance Editing to Include New Speci-
men 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 Mainte-
nance Organization (HMO) Processing.
1623 ................................................ Using scrubbed Medicare beneficiary/legal rep address data within the Fee-For-Service (FFS) systems—
Analysis and Design.

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28080 Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices

concerning completed decisions, as well well as pending decisions has also been www.cms.gov/medicare-coverage-
as sections on program and decision posted on the CMS Web site. For the database/. For questions or additional
memoranda, which also announce purposes of this quarterly notice, we are information, contact Wanda Belle (410–
decisions or, in some cases, explain why providing only the specific updates that 786–7491).
it was not appropriate to issue an NCD. have occurred in the 3-month period.
Information on completed decisions as This information is available at:

Transmittal
Title NCDM section Issue date Effective date
number

Screening for the Human Immunodeficiency Virus (HIV) In- NCD 210.7 ............................. R190 02/05/2016 04/13/2015
fection.
Screening for Cervical Cancer With Human Papillomavirus NCD 210.2.1 .......................... R189 02/02/2016 07/09/2015
(HPV) Testing—National Coverage Determination (NCD).

Addendum V: FDA-Approved Category number. For the purposes of this one of three classes. To assist CMS
B Investigational Device Exemptions quarterly notice, we list only the under this categorization process, the
(IDEs) (January through March 2016) specific updates to the Category B IDEs FDA assigns one of two categories to
as of the ending date of the period each FDA-approved investigational
Addendum V includes listings of the covered by this notice and a contact device exemption (IDE). Category A
FDA-approved investigational device person for questions or additional refers to experimental IDEs, and
exemption (IDE) numbers that the FDA information. For questions or additional Category B refers to non-experimental
assigns. The listings are organized information, contact John Manlove IDEs. To obtain more information about
according to the categories to which the (410–786–6877). the classes or categories, please refer to
devices are assigned (that is, Category A Under the Food, Drug, and Cosmetic the notice published in the April 21,
or Category B), and identified by the IDE Act (21 U.S.C. 360c) devices fall into 1997 Federal Register (62 FR 19328).

IDE Device Start date

BB16806 ................................................... MarrowStim P.A.D. Kit: Concentration of autologous bone marrow aspirate (cBMA) 01/22/2016
G130034 ................................................... BIOFREEDOM Drug Coated Coronary Stent System ................................................. 02/10/2016
G150002 ................................................... Silhouette Instalift ......................................................................................................... 01/08/2016
G150154 ................................................... RA–308 Excimer Laser System and DABRA Catheter Model 101 ............................. 01/08/2016
G150269 ................................................... Sodium Hyaluronate (1%) Ophthalmic Viscoelastc Devices (OVD), Sodium Hyaluro- 01/06/2016
nate (2.3%) Ophthalmic Viscoelastic Devices (OVD).
G150270 ................................................... Embozene Microspheres ............................................................................................. 01/08/2016
G150273 ................................................... Medtronic Activa PC+S Deep Brain Stimulation System ............................................ 01/15/2016
G150275 ................................................... Optune (Novocure’s Tumor Treating Electric Fields [TTFIELDS] Therapy) ................ 03/24/2016
G150278 ................................................... SAPIEN 3 Transcatheter Heart Valve and Accessories .............................................. 01/14/2016
G150282 ................................................... Berlin Heart EXCOR Pediatric Ventricular Assist Device ............................................ 01/28/2016
G160002 ................................................... FlowTriever Retrieval/Aspiration System ..................................................................... 02/03/2016
G160004 ................................................... Embosphere Microspheres .......................................................................................... 02/04/2016
G160008 ................................................... Investigational LabCorp MGMT Methylation-Specific PCR Companion DIagnostic 02/10/2016
Assay.
G160009 ................................................... Medtronic PC+S Deep Brain Stimulation system ........................................................ 02/11/2016
G160011 ................................................... CP950 Sound Processor (Kanso) ................................................................................ 02/17/2016
G160015 ................................................... JetStream (Boston Scientific) Atherectomy ................................................................. 02/19/2016
G160018 ................................................... Deep brain stimulation (DBS) in patients with refractory chronic neuropathic pain .... 03/23/2016
G160019 ................................................... CT–DBS for Traumatic Brain Injury using the Medtronic Activa PC+S System ......... 02/26/2016
G160021 ................................................... A Feasibility Study to Evaluate Safety and Initial Effectiveness of MR-Guided Fo- 03/02/2016
cused Ultrasound Ablation Therapy in the Treatment of Subcortical Lesional Epi-
lepsy.
G160022 ................................................... CoreValve Evolut R System, Medtronic CoreValve System ....................................... 02/17/2016
G160023 ................................................... NeuroStar TMS Therapy System with the NeuroStar XPLOR Clinical Research 03/04/2016
System.
G160025 ................................................... Medtronic DBS Lead Model 3387 ................................................................................ 03/04/2016
G160028 ................................................... NeuroBlate System ...................................................................................................... 03/09/2016
G160029 ................................................... VENTANA HA CDx Assay ........................................................................................... 03/10/2016
G160033 ................................................... Veterans Administration Lung Cancer Surgery or Stereotactic Radiotherapy 03/09/2016
(VALOR).
G160035 ................................................... Misago RX Self-expanding Peripheral Stent ............................................................... 03/17/2016
G160038 ................................................... MYELOTEC VIDEO GUIDED CATHETER; MYELOTEC MYELOSCOPE ................. 03/17/2016
G160039 ................................................... Medtronic TAVR 2.0 System ....................................................................................... 03/16/2016
G160041 ................................................... The Ulthera System; DS 4–4.5S, Simulines Transducer;DS 4–3.0S, Simulines 03/18/2016
mstockstill on DSK3G9T082PROD with NOTICES

Transducer; DS 4–4.5, Standard Transducer; DS 7–3.0, Standard Transducer.
G160042 ................................................... LUMENATI SYSTEM ................................................................................................... 03/18/2016
G160043 ................................................... Senza Spinal Cord Stimulation (SCS) System ............................................................ 03/23/2016
G160045 ................................................... NeuroStar TMS Therapy System with the NeuroStar XPLOR Clinical Research 03/24/2016
System.

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Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices 28081

Addendum VI: Approval Numbers for Addendum VII: Medicare-Approved optimal patient outcomes. We have
Collections of Information (January Carotid Stent Facilities, (October created a list of minimum standards for
through March 2016) through December 2015) facilities modeled in part on
Addendum VII includes listings of professional society statements on
All approval numbers are available to competency. All facilities must at least
Medicare-approved carotid stent
the public at Reginfo.gov. Under the facilities. All facilities listed meet CMS meet our standards in order to receive
review process, approved information standards for performing carotid artery coverage for carotid artery stenting for
collection requests are assigned OMB stenting for high risk patients. On March high risk patients. For the purposes of
control numbers. A single control 17, 2005, we issued our decision this quarterly notice, we are providing
number may apply to several related memorandum on carotid artery stenting. only the specific updates that have
information collections. This We determined that carotid artery occurred in the 3-month period. This
information is available at stenting with embolic protection is information is available at: http://
www.reginfo.gov/public/do/PRAMain. reasonable and necessary only if www.cms.gov/
For questions or additional information, performed in facilities that have been MedicareApprovedFacilitie/CASF/
contact Mitch Bryman (410–786–5258). determined to be competent in list.asp#TopOfPage For questions or
performing the evaluation, procedure, additional information, contact Lori
and follow-up necessary to ensure 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 Highway 37 West Toms River, NJ 310041 01/07/2016 NJ.
08755.
Las Palmas Medical Center, 1801 North Oregon, El Paso, TX 79902 ........................... 1770536120 01/07/2016 TX.
Sky Ridge Medical Center, 10101 Ridgegate Parkway, Lone Tree, CO 80124 .............. 060112 01/04/2016 CO.
McLaren Port Huron, 1221 Pine Grove Port, Huron, MI 48061 ....................................... 1982685384 01/04/2016 MI.
DMC Huron Valley—Sinai Hospital, 1 Williams Carls Drive, Commerce, MI 48382 ....... 1922310200 01/04/2016 MI.
Valley Baptist Medical Center—Brownsville, PO Box 450028, 1040 West Jefferson, 450028 03/09/2016 TX.
Brownsville, TX 78520.
Manchester Memorial Hospital, 71 Haynes Street, Manchester, CT 06040 .................... 1457399198 03/09/2016 CT.
Grand Stand Medical Center, 809 82nd Parkway, Myrtle Beach, SC 29572 .................. 1083668669 03/23/2016 SC.
Ben Taub Hospital, 1504 Taub Loop, Houston, TX 77030 .............................................. 450289 03/30/2016 TX.

The following facilities have editorial changes (in bold)

FROM: Saint Joseph Medical Center, TO: St. Joseph Medical Center, 2500 Bernville 390096 04/01/2005 PA.
Road, Reading, PA 19605.
FROM: Helen Ellis Memorial Hospital, TO: Florida Hospital North Pinellas, 1395 South 100055 01/20/2009 FL.
Pinellas Avenue, Tarpon Springs, FL 34689.

The following facility has been removed from the listing of approved facilities

Rockingham Memorial Hospital, 235 Cantrell Avenue, Harrisonburg, VA 22801 ............ 490004 06/30/2010 VA.

Addendum VIII: American College of transition to the ACC–NCDR ICD Exemption trial studying ICDs as
Cardiology’s National Cardiovascular Registry by April 2006. identified by the FDA or in the ACC–
Data Registry Sites (January through Effective January 27, 2005, to obtain NCDR ICD registry. Therefore, for a
March 2016) reimbursement, Medicare NCD policy beneficiary to receive a Medicare-
requires that providers implanting ICDs covered ICD implantation for primary
Addendum VIII includes a list of the for primary prevention clinical prevention, the beneficiary must receive
American College of Cardiology’s indications (that is, patients without a the scan in a facility that participates in
National Cardiovascular Data Registry history of cardiac arrest or spontaneous the ACC–NCDR ICD registry. The entire
Sites. We cover implantable cardioverter arrhythmia) report data on each primary list of facilities that participate in the
defibrillators (ICDs) for certain clinical prevention ICD procedure. Details of the ACC–NCDR ICD registry can be found at
indications, as long as information clinical indications that are covered by www.ncdr.com/webncdr/common
about the procedures is reported to a Medicare and their respective data
central registry. Detailed descriptions of reporting requirements are available in For the purposes of this quarterly
the covered indications are available in the Medicare NCD Manual, which is on notice, we are providing only the
the NCD. In January 2005, CMS the CMS Web site at http:// specific updates that have occurred in
established the ICD Abstraction Tool www.cms.hhs.gov/Manuals/IOM/ the 3-month period. This information is
through the Quality Network Exchange itemdetail.asp?filter available by accessing our Web site and
(QNet) as a temporary data collection clicking on the link for the American
mstockstill on DSK3G9T082PROD with NOTICES

Type=none&filterByDID
mechanism. On October 27, 2005, CMS =99&sortByDID=1&sortOrder College of Cardiology’s National
announced that the American College of =ascending&itemID=CMS014961 Cardiovascular Data Registry at:
Cardiology’s National Cardiovascular A provider can use either of two www.ncdr.com/webncdr/common. For
Data Registry (ACC–NCDR) ICD Registry mechanisms to satisfy the data reporting questions or additional information,
satisfies the data reporting requirements requirement. Patients may be enrolled contact Marie Casey, BSN, MPH (410–
in the NCD. Hospitals needed to either in an Investigational Device 786–7861).

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28082 Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices

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 Center of Long Beach ......................................... Long Beach CA.
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—Franklin, Inc .......................................................... Milwaukee WI.
Andalusia Regional Hospital ........................................................................................ Andalusia AL.
Parkway Surgical & Cardiovascular Hospital ............................................................... Fort Worth TX.
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 Surgery Center ............................................................... Houston TX.
Surgery Center of Enid, Inc. ........................................................................................ Enid OK.
UPMC East ................................................................................................................... Monroeville PA.
Straith Hospital For Special Surgery ............................................................................ Southfield MI.
Bay Area Hospital ........................................................................................................ Coos Bay OR.
Kaiser Permanente Irvine Medical Center ................................................................... Irvine CA.
Cohen Children’s Medical Center ................................................................................ New Hyde NY.
Park

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 Acadiana ......................................................................... Lafayette LA.
CHI Health St. Elizabeth .............................................................................................. Lincoln NE.
Ochsner North Shore Covington .................................................................................. Covington LA.
Central Carolina (LifePoint) .......................................................................................... Sanford NC.
Mohammed Bin Khalifa Cardiac Centre ...................................................................... Riffa International.
Rockdale Medical Center ............................................................................................. Conyers GA.

Addendum IX: Active CMS Coverage- additional information, contact JoAnna In January 2005, we issued our
Related Guidance Documents (January Baldwin (410–786–7205). decision memorandum on positron
through March 2016) emission tomography (PET) scans,
Addendum X: List of Special One-Time
which stated that CMS would cover PET
CMS issued a guidance document on Notices Regarding National Coverage
scans for particular oncologic
November 20, 2014 titled ‘‘Guidance for Provisions (January through March
indications, as long as they were
the Public, Industry, and CMS Staff: 2016)
performed in the context of a clinical
Coverage with Evidence Development
There were no special one-time study. We have since recognized the
Document’’. Although CMS has several
notices regarding national coverage National Oncologic PET Registry as one
policy vehicles relating to evidence
provisions published in the 3-month of these clinical studies. Therefore, in
development activities including the
period. This information is available at order for a beneficiary to receive a
investigational device exemption (IDE),
www.cms.hhs.gov/coverage. For Medicare-covered PET scan, the
the clinical trial policy, national
questions or additional information, beneficiary must receive the scan in a
coverage determinations and local
coverage determinations, this guidance contact JoAnna Baldwin (410–786 facility that participates in the registry.
document is principally intended to 7205). There were no additions, deletions, or
help the public understand CMS’s editorial changes to the listing of
Addendum XI: National Oncologic PET National Oncologic Positron Emission
implementation of coverage with Registry (NOPR) (January through
evidence development (CED) through Tomography Registry (NOPR) in the 3-
March 2016)
the national coverage determination month period. This information is
mstockstill on DSK3G9T082PROD with NOTICES

process. The document is available at Addendum XI includes a listing of available at http://www.cms.gov/
http://www.cms.gov/medicare-coverage- National Oncologic Positron Emission MedicareApprovedFacilitie/NOPR/
database/details/medicare-coverage- Tomography Registry (NOPR) sites. We list.asp#TopOfPage. For questions or
document-details.aspx?MCDId=27. cover positron emission tomography additional information, contact Stuart
There are no additional Active CMS (PET) scans for particular oncologic Caplan, RN, MAS (410–786–8564).
Coverage-Related Guidance Documents indications when they are performed in
for the 3-month period. For questions or a facility that participates in the NOPR.

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
FR Citation		81 FR 28072

81 FR 28072 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2016

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 81, Issue 89 (May 9, 2016)

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