Federal Register: September 25, 2009 (Volume 74, Number 185)

DOCID: fr25se09-168 FR Doc E9-22160

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Western Area Power Administration

CMS ID: [CMS-9053-N]

NOTICE: Part II

DOCID: fr25se09-168

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY:

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--April through June 2009

DOCUMENT SUMMARY:

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April 2009 through June 2009, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coveragerelated guidance documents, and special onetime notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicareapproved ventricular assist device (destination therapy) facilities, a list of Medicareapproved lung volume reduction surgery facilities, a list of Medicareapproved clinical trials for fluorodeoxyglucose positron emissions tomogragphy for dementia, and a list of Medicareapproved bariatric surgery facilities.

Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3month time frame.

SUMMARY:

Health and Human Services Department, Centers for Medicare & Medicaid Services

SUPPLEMENTAL INFORMATION

I. Program Issuances

The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs. These programs pay for health care and related services for 39 million Medicare beneficiaries and 35 million Medicaid recipients. Administration of the two programs involves (1) furnishing information to Medicare beneficiaries and Medicaid recipients, health care providers, and the public and (2) maintaining effective communications with regional offices, State governments, State Medicaid agencies, State survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, and others. 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). We also issue various manuals, memoranda, and statements necessary to administer the programs efficiently.

Section 1871(c)(1) 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. We published our first notice June 9, 1988 (53 FR 21730). Although we are not mandated to do so by statute, for the sake of completeness of the listing of operational and policy statements, and to foster more open and transparent collaboration, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the respective 3month time frame. II. How To Use the Addenda

This notice is organized so that a reader may review the subjects of manual issuances, memoranda, substantive and interpretive regulations, NCDs, and FDAapproved IDEs published during the subject quarter to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals may wish to review Table I of our first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) published in 1988, and the notice published March 31, 1993 (58 FR 16837). Those desiring information on the Medicare NCD Manual (NCDM, formerly the Medicare Coverage Issues Manual (CIM)) may wish to review the August 21, 1989, publication (54 FR 34555). Those interested in the revised process used in making NCDs under the Medicare program may review the September 26, 2003, publication (68 FR 55634).

To aid the reader, we have organized and divided this current listing into 11 addenda:

  • Addendum I lists the publication dates of the most recent quarterly listings of program issuances.
  • Addendum II identifies previous Federal Register documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda.
  • Addendum III lists a unique CMS transmittal number for each instruction in our manuals or Program Memoranda and its subject matter. 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 manuals.
  • Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the Federal Register during the quarter covered by this notice. For each item, we list the
    [cir] Date published;
    [cir] Federal Register citation;
    [cir] Parts of the Code of Federal Regulations (CFR) that have changed (if applicable);
    [cir] Agency file code number; and
    [cir] Title of the regulation.
  • Addendum V includes completed NCDs, or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCDM in which the decision appears, the title, the date the publication was issued, and the effective date of the decision.
  • Addendum VI includes listings of the FDAapproved IDE categorizations, using the IDE numbers the FDA assigns. The listings are organized according to the categories to which the device numbers are assigned (that is, Category A or Category B), and identified by the IDE number.
  • Addendum VII includes listings of all approval numbers from the Office of Management and Budget (OMB) for collections of information in CMS regulations in title 42; title 45, subchapter C; and title 20 of the CFR.
  • Addendum VIII includes listings of Medicareapproved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients.
  • Addendum IX includes a list of the American College of Cardiology's National Cardiovascular Data registry sites. We cover implantable cardioverter defibrillators (ICDs) for certain indications, as long as information about the procedures is reported to a central registry.
  • Addendum X includes a list of active CMS guidance documents. As required by section 731 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108 173, enacted on December 8, 2003), we will begin listing the current versions of our guidance documents in each quarterly listings notice.
  • Addendum XI includes a list of special onetime notices regarding national coverage provisions. We are publishing a list of issues that require public notification, such as a particular clinical trial or research study that qualifies for Medicare coverage.
  • Addendum XII 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.
  • Addendum XIII includes a listing of Medicareapproved facitilites that receive coverage for ventricular assist devices used as destination therapy. All facilities were required to meet our standards in order to receive coverage for ventricular assist devices implanted as destination therapy.
  • Addendum XIV includes a listing of Medicareapproved 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 are also eligible to receive coverage.
  • Addendum XV includes a listing of Medicareapproved facilities that meet minimum standards for facilities modeled in part on professional society statements on competency. All facilities [[Page 49078]]
    must meet our standards in order to receive coverage for bariatric surgery procedures.
  • Addendum XVI includes a listing of Medicareapproved clinical trials for fluorodeoxyglucose positron emission tomography (FDGPET) for dementia and neurodegenerative diseases.
    III. How To Obtain Listed Material

    A. Manuals

    Those wishing to subscribe to program manuals should contact either the Government Printing Office (GPO) or the National Technical Information Service (NTIS) at the following addresses:
    Superintendent of Documents, Government Printing Office, ATTN: New Orders, P.O. Box 371954, Pittsburgh, PA 152507954, Telephone (202) 5121800, Fax number (202) 5122250 (for credit card orders); or National Technical Information Service, Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161, Telephone (703) 4874630.

    In addition, individual manual transmittals and Program Memoranda listed in this notice can be purchased from NTIS. Interested parties should identify the transmittal(s) they want. GPO or NTIS can give complete details on how to obtain the publications they sell. Additionally, most manuals are available at the following Internet address: http://cms.hhs.gov/manuals/default.asp. B. Regulations and Notices

    Regulations and notices are published in the daily Federal Register. Interested individuals may purchase individual copies or subscribe to the Federal Register by contacting the GPO at the address given above. 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 also available on 24x microfiche and 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) forward. Free public access is available on a Wide Area Information Server (WAIS) through the Internet and via asynchronous dialin. Internet users can access the database by using the World Wide Web; the Superintendent of Documents home page address is http:// www.gpoaccess.gov/fr/index.html, by using local WAIS client software, or by telnet to http://swais.gpoaccess.gov, then log in as guest (no password required). Dialin users should use communications software and modem to call (202) 5121661; type swais, then log in as guest (no password required).

    C. Rulings

    We publish rulings on an infrequent basis. 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. Interested individuals can obtain copies from the nearest CMS Regional Office or review them at the nearest regional depository library. We have, on occasion, published rulings in the Federal Register. Rulings, beginning with those released in 1995, are available online, through the CMS Home Page. The Internet address is http:// cms.hhs.gov/rulings.

    D. CMS' Compact DiskRead Only Memory (CDROM)

    Our laws, regulations, and manuals are also available on CDROM and may be purchased from GPO or NTIS on a subscription or single copy basis. The Superintendent of Documents list ID is HCLRM, and the stock number is 717139000003. The following material is on the CDROM disk:

  • Titles XI, XVIII, and XIX of the Act.
  • CMSrelated regulations.
  • CMS manuals and monthly revisions.
  • CMS program memoranda.

    The titles of the Compilation of the Social Security Laws are current as of January 1, 2005. (Updated titles of the Social Security Laws are available on the Internet at http://www.ssa.gov/OP_Home/ ssact/comptoc.htm.) The remaining portions of CDROM are updated on a monthly basis.

    Because of complaints about the unreadability of the Appendices (Interpretive Guidelines) in the State Operations Manual (SOM), as of March 1995, we deleted these appendices from CDROM. We intend to re visit this issue in the near future and, with the aid of newer technology, we may again be able to include the appendices on CDROM.

    Any cost report forms incorporated in the manuals are included on the CDROM disk as LOTUS files. LOTUS software is needed to view the reports once the files have been copied to a personal computer disk. IV. How To Review Listed Material

    Transmittals or Program Memoranda can be reviewed 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.

    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.

    For each CMS publication listed in Addendum III, CMS publication and transmittal numbers are shown. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the Medicare Benefit Policy publication titled ``Surgery for Diabetes,'' use CMSPub. 10003, Transmittal No. 100.
    (Catalog of Federal Domestic Assistance Program No. 93.773, MedicareHospital Insurance, Program No. 93.774, Medicare
    Supplementary Medical Insurance Program, and Program No. 93.714, Medical Assistance Program)

    Dated: September 3, 2009.
    Jacquelyn Y. White,
    Director, Office of Strategic Operations and Regulatory Affairs. Addendum I

    This addendum lists the publication dates of the most recent quarterly listings of program issuances.
    June 22, 2007 (72 FR 34508)
    September 28, 2007 (72 FR 55282)
    December 28, 2007 (72 FR 73990)
    April 1, 2008 (73 FR 17422)
    June 27, 2008 (73 FR 36596)
    September 26, 2008 (73 FR 55902)
    December 30, 2008 (73 FR 79982)
    March 27, 2009 (74 FR 13516)
    June 26, 2009 (74 FR 30689)
    Addendum IIDescription of Manuals, Memoranda, and CMS Rulings

    An extensive descriptive listing of Medicare manuals and memoranda was published on June 9, 1988, at 53 FR 21730 and supplemented on September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 50577. Also, a complete description of the former CIM (now the NCDM) was published on
    [[Page 49079]]
    August 21, 1989, at 54 FR 34555. A brief description of the various Medicaid manuals and memoranda that we maintain was published on October 16, 1992, at 57 FR 47468.
    Addendum IIIMedicare and Medicaid Manual Instructions [April through June 2009]
    Transmittal No. Manual/Subject/Publication No. Medicare General Information
    (CMSPub. 10001)
    00....................... None
    Medicare Benefit Policy
    (CMSPub. 10002)
    105...................... List of Medicare Telehealth Services Originating Site Facility Fee Payment (ESRD Related Services)
    106...................... SpeechLanguage Pathology Private Practice Payment Policy
    Practice of SpeechLanguage Pathology Services Furnished by a Therapist in Private Practice
    107...................... July 2009 Update of the Hospital Outpatient Prospective Payment System
    Outpatient Observation Services
    Medicare National Coverage Determination
    (CMSPub. 10003)
    100...................... Surgery for Diabetes
    Bariatric Surgery for Treatment of Morbid Obesity (Various Effective Dates Below) Surgery for Diabetes (Effective February 12, 2009)
    101...................... Wrong Surgical or Other Invasive Procedure Performed on a Patient; Surgical or Other Invasive Procedure Performed on the Wrong Body Part; Surgical or Other Invasive Procedure Performed on the Wrong Patient Wrong Surgical or Other Procedure Performed on a Patient (Effective January 15, 2009) Surgical or Other Invasive Procedure Performed on the Wrong Body Part (Effective January 15, 2009)
    Medicare Claims Processing
    (CMSPub. 10004)
    1708..................... Hospice Cap Calculations Letters and Administrative Appeals
    1709..................... Manualization of the Medicare Physician Fee Schedule Record Layouts for Contractors Processing Institutional Claims Intermediary and Regional Home Health Intermediary Record Layout for Clinical Laboratory Fee Schedule
    RHHI Fees for Hospice, Radiology and Other Diagnostic Prices and Local HCPCS Codes Intermediary Format for Durable Medical Equipment, Prosthetic, Orthotic and Supply Fee Schedule
    Intermediary Outpatient Rehabilitation and CORF Services Fee Schedule
    Intermediary Format for Skilled Nursing Facility Fee Schedule
    Intermediary Format for CORF Services Supplemental and Critical Access Hospital Fee Schedule
    Physician Fee Schedule Payment Policy Indicator File Record Layout
    Intermediary Format for Mammography Fee Schedule
    Intermediary Format for Ambulance Fee Schedule
    1710..................... Billing Routine Cost of Clinical Trials Carrier Specific Requirements for Certain Specialties/Services
    Requirements for Billing Routine Costs of Clinical Trials
    1711..................... Surgery for Diabetes
    General
    ICD9 Procedure Codes for Bariatric Surgery (FIs Only)
    Claims Guidance for Payment Medicare Summary Notices (MSNs) and Claim Adjustment Reason Codes
    1712..................... Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction
    1713..................... Additional Data Collection on Hospice Claims Data Required on Claim to FI
    1714..................... Correction to Editing of Health Insurance Prospective Payment System Codes on Home Health Prospective Payment System Claims Home Health Prospective Payment System Claims 1715..................... New Physician Specialty Code for Hospice and Palliative Care
    Physician Specialty Codes
    1716..................... List of Medicare Telehealth Services List of Medicare Telehealth Services Submission of Telehealth Claims for Distant Site Providers
    1717..................... SpeechLanguage Pathology Privateacility ServicesGeneral
    Part B Outpatient Rehabilitation and Comprehensive Outpatient Rehabilitation Facility ServicesGeneral
    Services Paid Under the Medicare Physician's Fee Schedule
    Addendum
    1718..................... New Patient Discharge Status Code 21 to Define Discharges or Transfers to Court/Law Enforcement
    Form Locators 1630
    1719..................... Rural Health Clinic and Federally Qualified Health Clinic Updates
    RHCs/FQHCs Special Billing Instructions [[Page 49080]]
    General Billing Requirements for Preventive Services
    Initial Preventive Physical Exam Ultrasound Screening for Abdominal Aortic Aneurysms
    Diabetes SelfManagement Training Services Medical Nutrition Therapy Services RHCs/FQHCs Special Billing Instructions HCs/FQHCs Special Billing Instructions RHCs/FQHCs Special Billing Instructions 1720..................... Health Insurance Portability and Accountability Act American National Standards Institute (ANSI) 837 5010 Coordination of Benefit RequirementsPart II
    COB Trading Partner and Contractor Crossover Claim Requirements
    Coordination of Benefits Agreement Coordination of Benefits Requirements 1721..................... Billing Routine Cost of Clinical Trials Carrier Specific Requirements for Certain Specialties/Services
    Requirements for Billing Routine Cost of Clinical Trials
    1722..................... Instructions for Downloading the Medicare ZIP Code Files for October 2009
    1723..................... Only Clinical Trial Services Receive FeeFor Service Payment on Claims Billed for Managed Care Beneficiaries
    Requirements for Billing Routine Costs of Clinical Trials
    Billing and Processing Fee for Service Claims for Covered Clinical Trial Services Furnished to Managed Care Enrollees 1724..................... Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction
    1725..................... Requirements for Specialty Codes Requirements for Specialty Codes 1726..................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction
    1727..................... Coordination of Benefits Agreement (COBA) Repair and Claims Recovery Requirements Stemming from the Health Insurance Portability and Accountability Act 5010 Claims Transactions
    Coordination of Benefits Agreement 837 5010 Coordination of Benefits Flat File Errors Coordination of Benefits Agreement Full Claims Repair Process
    Coordination of Benefits Agreement (COBA) Eligibility File Claims Recovery Process 1728..................... Surgery for Diabetes
    General
    ICD9 Procedure Codes for Bariatric Surgery (FIs Only)
    Claims Guidance for Payment
    Medicare Summary Notices and Claim Adjustment Reason Codes
    1729..................... Section 148 of the Medicare Improvements for Patients and Providers Act (MIPPA) Clinical Diagnostic Laboratory Tests Furnished by CAHs
    Hospital and Skilled Nursing Facility Patients
    General Explanation of Payment
    Hospital Billing Under Part B
    Critical Access Hospital Outpatient Laboratory Service
    1730..................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction
    1731..................... Clarification of CMS Publication 10004, Chapter 32, Section 80.8 Billing of Routine Foot Care When Payment Ceases for Loss of Protective Sensation Evaluation and Management
    Billing Requirements for Special Services 1732..................... Pricing Claims for Services Rendered in Place of Service Home
    General Billing Requirements
    Medicare Claims Processing Manual/Chapter 1/ General Billing Requirements/Table of Contents
    Payment Jurisdiction Among Contractors for Services Paid Under the Physician Fee Schedule and Anesthesia Services Claims Processing Instructions for Payment Jurisdiction for Claims Received on or after April 1, 2004
    1733..................... Manual Clarifications for Skilled Nursing Facility and Therapy Billing
    Inpatient Billing from Hospitals and SNFs HCPCS Coding Requirements
    Special Inpatient Billing Instructions Bills with Covered and Noncovered Days Billing in Benefits Exhaust and NoPayment Situations
    1734..................... Claim Adjustment Reason Code (CARC), Remittance Advice Remark Code and Medicare Remit Easy Print Update
    1735..................... Changes to the Laboratory National Coverage Determination Edit Software for July 2009 1736..................... Chapter 24 Update to Restore Inadvertently Deleted Information and to Remove Reserved
    Reserved
    Contractor Roles in ASCA Reviews 1737..................... July 2009 Quarterly Average Sales Price Medicare Part B Drug Pricing
    Files and Revisions to Prior Quarterly Pricing Files
    1738..................... Additional Data Collection on Hospice Claims Data Required on Claim to FI
    1739..................... July 2009 Integrated Outpatient Code Editor Specifications Version 10.2
    1740..................... July 2009 Update to the ASC Payment System; Summary of Payment Policy Changes 1741..................... UpdateInpatient Psychiatric Facilities Prospective Payment System Rate Year 2010 1742..................... Clarification of Chapter 32, Section 80.8 Billing of Routine Foot Care When Payment Ceases for Loss of Protective Sensation Evaluation and Management
    Billing Requirements for Special Services 1743..................... Billing Routine Cost of Clinical Trials [[Page 49081]]
    Carrier Specific Requirements for Certain Specialties/Services
    Requirements for Billing Routine Cost of Clinical Trials
    1744..................... Manual Update to Include Billing Instructions for Professional Component and Technical Component in Regards to One Line Global Billing for Pathology Services DOS for Clinical Laboratory and Pathology Specimen 1745..................... July 2009 Update of the Hospital Outpatient Prospective Payment System When an Inpatient Admission May Be Changed to Outpatient Status
    Background
    Policy and Billing Instructions for Condition Code 44
    Outlier Adjustments
    Identifying Hospitals and CMHCs Subject to Outlier Reconciliation
    Reconciling Outlier Payments for Hospitals and CMHCs
    Time Value of Money
    Procedures for Medicare Contractors to Perform and Record Outlier
    Reconciliation Adjustments
    Observation Services Overview
    Revenue Code Reporting
    Reporting Hours of Observation
    Billing and Payment for All Hospital Observation Services Furnished between January 1, 2006 and December 31, 2007 Separate and Packaged Payment for Direct Referral for Observation Services Furnished between January 1, 2006 and December 31, 2007
    Separate and Packaged Payment for Observation Services Furnished between January 1, 2006 and December 31, 2007
    Billing and Payment for Observation Services Beginning January 1, 2008
    Billing and Payment for Direct Referral for Observation Care Furnished Beginning January 1, 2008
    Hospital Outpatient Payment Under OPPS for New, Unclassified Drugs and Biologicals After FDA Approval But Before Assignment of a ProductSpecific Drug or Biological HCPCS Code
    1746..................... Quarterly Update to Correct Coding Initiative Edits, Version 15.2, Effective July 1, 2009 1747..................... BeneficiarySubmitted Claims
    Monitoring Claims Submission Violations Handling Incomplete or Invalid Claims 1748..................... July Update to the 2009 Medicare Physician Fee Schedule Database
    1749..................... Revised Billing Instructions for Occurrence Span Code 74 on Skilled Nursing Facility No Payment Claims
    Billing in Benefits Exhaust and NoPayment Situations
    1750..................... October Quarterly Update to 2009 Annual Update of HCPCS Codes Used for Skilled Nursing Facility Consolidated Billing Enforcement
    1751..................... New Waived Tests
    1752..................... Addition/Deletion of HCPCS CodesJuly 2009 Quarterly Update
    1753..................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction
    1754..................... July Quarterly Update for 2009 Durable Medical Equipment, Prosthetics, Orthotics, and Suppliers Fee Schedule
    1755..................... Wrong Surgical or Other Invasive Procedure Performed on a Patient; Surgical or Other Invasive Procedure Performed on the Wrong Body Part; Surgical or Other Invasive Procedure Performed on the Wrong Patient Billing Wrong Surgical or Other Invasive Procedures Performed on a Patient, Surgical or Other Invasive Procedures Performed on the Wrong Body Part, and Surgical or Other Invasive Procedures Performed on the Wrong Patient
    1756..................... Claim Status Category Code and Claim Status Code Update
    1757..................... Claims Processing for Skilled Nursing Facility Consolidated Billing
    Carrier/Part B MAC/DMEMAC Claims Processing for Consolidated Billing for Physician and NonPhysician Practitioner Services Rendered to Beneficiaries in a SNF Part A Stay Reject and Unsolicited Response Edits A/B Crossover Edits
    Duplicate Edits
    Edit for Ambulance Services
    Edit for Clinical Social Workers (CSWs) Edit for Therapy Services Separately Payable when Furnished by a Physician
    CWF Override Codes
    Coding Files and Updates
    Annual Update Process
    1758..................... Correction to Fiscal Year (FY) 2009 Medicare Severity LongTerm Care DiagnosisRelated Group (MSLTCDRG) Weights
    1759..................... July 2009 Update to the ASC Payment System; Summary of Payment Policy Changes 1760..................... July 2009 Update of the Hospital Outpatient Prospective Payment System when an Inpatient Admission May Be Changed to Outpatient Status
    Background
    1761..................... Billing Routine Cost of Clinical Trials Carrier Specific Requirements for Certain Specialties/Services
    Requirements for Billing Routine Cost of Clinical Trials
    Policy and Billing Instructions for Condition Code 44
    Outlier Adjustments
    Identifying Hospitals and CMHCs Subject to Outlier Reconciliation
    Reconciling Outlier Payments for Hospitals and CMHCs
    Time Value of Money
    Procedures for Medicare Contractors to Perform and Record Outlier Reconciliation Adjustments
    Observation Services Overview
    Revenue Code Reporting
    [[Page 49082]]
    Reporting Hours of Observation
    Billing and Payment for All Hospital Observation Services Furnished Between January 1, 2006 and December 31, 2007 Billing and Payment for All Hospital Observation Services Furnished Between January 1, 2006 and December 31, 2007 Separate and Packaged Payment for Direct Referral for Observation Services Furnished Between January 1, 2006 and December 31, 2007
    Separate and Packaged Payment for Direct Referral for Observation Services Furnished Between January 1, 2006 and December 31, 2007
    Billing and Payment for Observation Services Beginning January 1, 2008
    Billing and Payment for Direct Referral for Observation Care Furnished Beginning January 1, 2008
    Hospital Outpatient Payment Under OPPS for New, Unclassified Drugs and Biologicals After FDA Approval But Before Assignment of a ProductSpecific Drug or Biological HCPCS Code
    Medicare Secondary Payer
    (CMSPub. 10005)
    68....................... Claim Adjustment Reason Code Update for Medicare Secondary Payer Claims Processing 69....................... Update to the Electronic Correspondence Referral System User Guide v10.0 and Quick Reference Card v10.0
    Coordination With the Coordination of Benefits Contractor
    Contractor MSP Auxiliary File Update Responsibility
    COBC Electronic Correspondence Referral System
    Attachment 1ECRS User Guide, Software Version 10.0
    Attachment 1AECRS Part D Plan User Guide, Software
    Providing Written Documents to the COBC 70....................... Instructions on utilizing 837 Institutional CAS segments for Medicare Secondary Payer Part A Claims
    Medicare Financial Management
    (CMSPub. 10006)
    150...................... Internal Control Requirements Update Introduction
    Authority
    FMFIA and the CMS Contractor Contract GAO Standards for Internal Controls in the Federal Government
    Definition and Objectives
    Monitoring
    Contractor Internal Control Review Process Risk Assessment
    Risk Analysis Chart
    Internal Control Objectives
    CMS Contractor Control Objectives Policies and Procedures
    Testing Methods
    Documentation and Working Papers Certification Package for Internal Controls OMB Circular A123, Appendix A: Internal Control Over Financial Reporting CPIC Requirements
    Certification Statement
    Executive Summary
    CPIC Report of Material Weaknesses CPIC Report of Internal Control Deficiencies Definitions of Control Deficiency, Significant Deficiency, and Material Weaknesses Corrective Action Plans Submission, Review, and Approval of Corrective Action Plans
    CMS Finding Numbers
    Initial CAP Report
    Quarterly CAP Report
    Entering Data into the Initial or Quarterly CAP Report
    List of CMS Contractor Control Objectives CMS Financial Reporting Cycle Memo Financial Reporting Cycle Memo Inclusions List of Appendices
    151...................... Notice of New Interest Rate for Medicare Overpayments and Underpayments3rd Notification for FY 2009
    152...................... Recovery Audit Contractors (RACs) Handling Appeals Resulting from RAC Initiated Denials
    Referrals to the Department of Treasury Tracking Overpayments
    Tracking Appeals
    Reporting Administrative Costs Directly Associated with the RAC Program Potential Fraud
    AC and MAC Requirements Involving RAC Information Dissemination
    Contacting NonResponders
    Voluntary Refunds
    Working with RAC Support Contractors [[Page 49083]]
    153...................... Implementation of the Redesigned Provider Statistical and Reimbursement (PS&R) System Contractor's Responsibility Prior to Submission of Cost Reports
    Medicare State Operations Manual
    (CMSPub. 10007)
    41....................... Revisions to Appendices P and PP 42....................... Revision to Appendix P, ``Survey Protocol for Long Term Care FacilitiesPart I'' ``Investigative ProtocolUnintended Weight Loss''
    43....................... Revised Chapter 2, ``The Certification Process,'' Section 2008A
    Early Surveys of New Providers and Suppliers 44....................... Revisions to Exhibit 286, ``Hospital/CAH Medicare Database Worksheet''
    45....................... Revisions to Chapter 6``Special Procedures for Laboratories''
    Background
    Consultative CLIA Activities
    Certificate of Registration
    Certificate of Compliance
    CLIA Certificate Status Changes
    Criteria for One Certificate for Multiple Sites
    Laboratories Under Direct RO Jurisdiction Laboratories Performing Limited Public Health Testing
    46....................... Revisions to Appendix V, ``Emergency Medical Treatment and Labor Act Interpretive Guidelines''
    47....................... Revised Appendix A, ``Interpretive Guidelines for Hospitals''
    48....................... Revisions to Appendix PP, ``Guidance to Surveyors of Long Term Care Facilities'' 49....................... New Critical Access Hospital (CAH) Requirements Under 42 CFR 485.610(e) Related to CAH Colocation and CAH Providerbased Locations
    Medicare Program Integrity
    (CMSPub. 10008)
    288...................... Incorporation of Physician Fee Schedule Regulatory Changes
    Definitions
    PreScreening Process
    Application Rejections
    Denials for Incomplete Applications Returning the Application
    Types of Business Organizations
    Certification Statement
    Delegated Officials
    IDTF Standards
    Requesting and Receiving Clarifying Information
    Definitions
    Determining Whether a CHOW Has Occurred Processing CHOW Applications
    Effective Billing Date for Physicians, Non Physician Practitioners, and Physician or NonPhysician Practitioner Organizations Denials
    General Procedures
    Electronic Fund Transfers
    Medicare Advantage and Other Managed Care Organizations
    Clinical Nurse Specialists
    Nurse Practitioners
    Physicians
    Speech Language Pathologists in Private Practice
    Contractor Issued Revocations
    File Maintenance
    289...................... Incorporation of Physician Fee Schedule Regulatory Changes
    Definitions
    PreScreening Process
    Application Rejections
    Denials for Incomplete Applications Returning the Application
    Types of Business Organizations
    Certification Statement
    Delegated Officials
    IDTF Standards
    Requesting and Receiving Clarifying Information
    Determining Whether a CHOW Has Occurred Effective Billing Date for Physicians, Non Physician Practitioners, and Physician or NonPhysician Practitioner Organizations Denials
    General Procedures
    Electronic Fund Transfers
    [[Page 49084]]
    Medicare Advantage and Other Managed Care Organizations
    Clinical Nurse Specialists
    Nurse Practitioners
    Speech Language Pathologists in Private Practice
    Contractor Issued Revocations
    File Maintenance
    291...................... Reassignment and Ambulatory Surgical Centers (ASCs)
    292...................... Submission of Paper and Electronic CMS855 Enrollment Applications
    293...................... Review of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Period of Medical Necessity for Serial DMEPOS claims
    Accessories
    Repairs
    Maintenance
    General DMEPOS Review Reminders
    294...................... Additional Extract from MultiCarrier System to Provider Enrollment, Chain and Ownership System for 4th Quarter Deactivations 295...................... Revision to Certain Instructions Related to Provider Enrollment Deactivations and Revocations
    Radiation Therapy Centers
    Certified Registered Nurse Anesthetists CMS or Contractor Issued Deactivations Contractor Issued Revocations
    DPSE Issued Revocations
    PSC Identified Revocations
    CMS Satellite Office or Regional Office Identified Revocations
    Medicare Contractor Beneficiary and Provider Communications (CMSPub. 10009)
    00....................... None
    Medicare End Stage Renal Disease Network Organizations (CMSPub 10014)
    00....................... None
    Medicare Managed Care
    (CMSPub. 10016)
    00....................... None
    Medicare Business Partners Systems Security
    (CMSPub. 10017)
    00....................... None
    Demonstrations
    (CMSPub. 10019)
    61....................... Method of Payment for Extended Stay Services under the Frontier Extended Stay Clinic Demonstration, Authorized by Section 434 of the Medicare Modernization Act. This Change Request provides additional information to CR 6057
    One Time Notification
    (CMSPub. 10020)
    469...................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction
    470...................... Expansion of the Current Scope of Editing for Ordering/Referring Providers for Claims Processed by Medicare Carriers and Part B Medicare
    Administrative Contractors
    471...................... Revision to Processing Hospice Visit Charges on Remittance Advices and Medicare Summary Notices
    472...................... Request for Common Working Files to Send Common Working Files Medicare Quality Assurance the 5010 File Formats as of October 5, 2009
    473...................... Deductible Application on Clinical Trial Claims
    474...................... Ten (10) percent Writeoff from the Nine CWF data bases for the Tables called: Medicare Secondary Payment and Beneficiary ESRD Dialysis Auxiliary, for the Calendar Years 20002008
    475...................... Modification to Accommodate Acute Care Episode Demonstration
    476...................... Implementation of Indirect Medical Education and Long Term Care Hospital Provisions from the American Recovery and Reinvestment Act of 2009
    477...................... Change Type of Bill (TOB) for Federally Qualified Health Centers from 73x to 77x 478...................... Internetbased Provider Enrollment, Chain and Ownership Outreach to Academic Medical Institutions and Large Group Practices [[Page 49085]]
    479...................... Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction
    480...................... Expansion of the Current Scope of Editing for Ordering/Referring Providers for Durable Medical Equipment, Prosthetics, Orthotics, and Supplier
    Suppliers Claims Process by Durable Medical Equipment Medicare Administrative Contractors
    481...................... Implementation of the Health Care Claim Status Inquiry and Response (276/277) Version 005010Durable Medical Equipment Shared System Change
    482...................... Mainframe Integrated Outpatient Code Editor Tool Set Upgrade
    483...................... Fiscal Intermediary Shared System Analysis for SystemRelated Outpatient Prospective Payment System Processing Issues 484...................... Archiving and Retrieving of the Integrated Outpatient Code Editor for Processing Claims 485...................... ImplementationSystems Improvements to Streamline Updates to the Place of Service Code Set
    486...................... Jurisdiction 5 A/B MAC Merge of the Part B East Missouri, West Missouri, Nebraska, Kansas, and Iowa Production and User Acceptance Test Regions
    487...................... Modification of the Common Working File Copybook to Transmit a ``WC'' Qualifier to Distinguish Workers Compensation Medicare SetAside
    Arrangement MSP Records
    488...................... Processing and Payment of Physician and Non Physician Practitioner Services Reassigned to ASCs
    489...................... Require Medicare Administrative Contractors Fiscal Intermediaries and Carriers to Provide Program Safeguard Contractors (PSCs)/ Zoned Program Integrity Contractors (ZPICs) with Monthly Updates of Deactivated Crosswalk File Entries
    490...................... Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction
    492...................... Fiscal Year 2009 Inpatient Prospective Payment System Claims with Medicare Severity Diagnosis Related Group (MSDRG) 956 494...................... MREP Update for 835 Version 5010 495...................... Further Instruction for Implementation of the Next Version of the Health Insurance Portability and Accountability Act 835 Transaction and Related Standard Paper Remittance
    496...................... Fiscal Intermediary Standard System Analysis and Technical Consultationto be Performed by the Maintainer for the Planning and Execution of the J1 WPS Legacy Part A Pilot Split and Subsequent Workload Reporting Requirements
    497...................... Payment for Maintenance and Servicing of Certain Oxygen Equipment as a Result of the Medicare Improvements for Patients and Providers Act of 2008THIS CR RESCINDS AND FULLY REPLACES CR 6404
    498...................... Reporting Gross Payments on IRS Form1099 499...................... Placing Medicare Florida Fraud Hotline Number on the Medicare Summary Notices for Zip Codes in Florida
    500...................... VMS Modifications to Implement the Common Electronic Data Interchange System, Part III, NCPDP 5.1 Implementation
    501...................... Allow Zoned Program Integrity Contractor to access Durable Medical Equipment Medicare Administrative Contractor by ZPIC Zone 502...................... Jurisdiction 4 A/B MAC Merge of the Part B Oklahoma, New Mexico and Colorado CICS Production and User Acceptance Test Regions 503...................... Reporting NonTax Withholding Due to Federal Payment Levy Program
    504...................... J12 Production Region Merge of the District of Columbia, Maryland, New Jersey, and Pennsylvania Part A Workloads
    505...................... Medicare Part B Radiation Therapy Centers Supplier Enrollment Revalidation 506...................... Issued to specific audience, not posted to Internet/Intranet/due to Sensitivity of Instruction
    507...................... Jurisdiction 13 A/B MAC Merge of the three Part B New York and the Part B Connecticut CICS Production and User Acceptance Test Regions
    508...................... Implementation of the Next Version of the Health Insurance Portability and Accountability Act (HIPAA) 835 Transaction 509...................... DME MAC Instructions for Therapy Caps 2009 510...................... Expansion of the Current Scope of Editing for Ordering/Referring Providers for claims processed by Medicare Carriers and Part B Medicare Administrative Contractors Addendum IVRegulation Documents Published in the Federal Register [April through June 2009] FR Vol. 74 42 CFR parts Publication date Page No. affected File code Title of regulation April 3, 2009.................. 15221 440................ CMS2232F2........ Medicaid Programs; State Flexibility for Medicaid Benefit Packages. April 24, 2009................. 18656 447 and 455........ CMS2198F2........ Medicaid Program; Disproportionate Share Hospital Payments; Correcting Amendment. April 24, 2009................. 18728 ................... CMS2299PN........ Medicare and Medicaid Programs; Application of the American Osteopathic Association for Continued Deeming Authority for Hospitals. April 24, 2009................. 18734 ................... CMS1563N......... Medicare Program; Meeting of the Practicing Physicians Advisory Council, June 1, 2009. April 24, 2009................. 18808 ................... CMS4139N......... Medicare Program; Recognition of NAIC Model Standards for Regulation of Medicare Supplemental Insurance. April 24, 2009................. 18912 405 and 418........ CMS1420P......... Medicare Program; Proposed Hospice Wage Index for Fiscal Year 2010. April 28, 2009................. 19155 45 CFR 144 and 146. CMS4140NC........ Request for Information Regarding the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008. [[Page 49086]]
    May 1, 2009.................... 20323 ................... CMS2303N......... Establishment of the Children's Health Insurance Program Working Group and Request for Nominations for Members. May 1, 2009.................... 20362 ................... CMS1495NC........ Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System Payment Update for Rate Year Beginning July 1, 2009 (RY 2010). May 6, 2009.................... 21052 412................ CMS1538P......... Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2010. May 6, 2009.................... 21230 433................ CMS2275P2........ Medicaid Program; Health CareRelated Taxes. May 6, 2009.................... 21232 431, 433, 440, and CMS2287P2, CMS Medicaid Program; 441. 2213P2, CMS2237 Rescission of P. School[dash]Based

    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 these items. Copies are not available through the contact persons. (See Section III of this notice for how to obtain listed material.)

    Questions concerning CMS manual instructions in Addendum III may be addressed to Ismael Torres, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C42605, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7861864.

    Questions concerning regulation documents published in the Federal Register in Addendum IV may be addressed to Gwendolyn Johnson, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C41403, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7866954.

    Questions concerning Medicare NCDs in Addendum V may be addressed to Patricia BrocatoSimons, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C10906, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7860261.

    Questions concerning FDAapproved Category B IDE numbers listed in Addendum VI may be addressed to John Manlove, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C113 04, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7866877.

    Questions concerning approval numbers for collections of information in Addendum VII may be addressed to Melissa Musotto, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C514 03, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7866962.

    Questions concerning Medicareapproved carotid stent facilities in Addendum VIII may be addressed to Sarah J. McClain, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C109 06, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7862994.

    Questions concerning Medicare's recognition of the American College of CardiologyNational Cardiovascular Data Registry sites in Addendum IX may be addressed to JoAnna Baldwin, MS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C10906, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7867205.

    Questions concerning Medicare's active coveragerelated guidance documents in Addendum X may be addressed to Beverly Lofton, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C10906, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7867136.

    Questions concerning onetime notices regarding national coverage provisions in Addendum XI may be addressed to Beverly Lofton, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C10906, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7867136.

    Questions concerning National Oncologic Positron Emission Tomography Registry sites in Addendum XII may be addressed to Stuart Caplan, RN, MAS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C10906, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7868564.

    Questions concerning Medicareapproved ventricular assist device (destination therapy) facilities in Addendum XIII may be addressed to JoAnna Baldwin, MS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C10906, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7867205.

    Questions concerning Medicareapproved lung volume reduction surgery facilities listed in Addendum XIV may be addressed to JoAnna Baldwin, MS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C10906, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7867205.

    Questions concerning Medicareapproved bariatric surgery facilities listed in Addendum XV may be addressed to Kate Tillman, RN, MA, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C10906, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7869252.

    Questions concerning fluorodeoxyglucose positron emission [[Page 49077]]
    tomography for dementia trials listed in Addendum XVI may be addressed to Stuart Caplan, RN, MAS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C10906, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7868564.

    Questions concerning all other information may be addressed to Gwendolyn Johnson, Office of Strategic Operations and Regulatory Affairs, Regulations Development Group, Centers for Medicare & Medicaid Services, C51403, 7500 Security Boulevard, Baltimore, MD 212441850, or you can call (410) 7866954.