Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2005, 55863-55885 [05-18926]

Agencies

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

[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Notices]
[Pages 55863-55885]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18926]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9032-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--April Through June 2005

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice lists CMS manual instructions, substantive and 
interpretive regulations, and other Federal Register notices that were 
published from April 2005 through June 2005, 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. Finally, this notice 
includes a list of Medicare-approved carotid stent 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 3-month time frame.

FOR FURTHER INFORMATION CONTACT: It is possible that an interested 
party may have a specific information need and not be able to determine 
from the listed information whether the issuance or regulation would 
fulfill that need. Consequently, we are providing information 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 items in Addendum III may be addressed to 
Timothy Jennings, Office of Strategic Operations and Regulatory 
Affairs, Centers for Medicare & Medicaid Services, C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 
786-2134.
    Questions concerning Medicare NCDs in Addendum V may be addressed 
to Patricia Brocato-Simons, Office of Clinical Standards and Quality, 
Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-0261.
    Questions concerning FDA-approved 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, S3-26-
10, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call 
(410) 786-6877.
    Questions concerning approval numbers for collections of 
information in Addendum VII may be addressed to Jim Wickliffe, Office 
of Strategic Operations and Regulatory Affairs,

[[Page 55864]]

Regulations Development and Issuances Group, Centers for Medicare & 
Medicaid Services, C5-14-03, 7500 Security Boulevard, Baltimore, MD 
21244-1850, or you can call (410) 786-4596.
    Questions concerning Medicare-approved carotid stent facilities may 
be addressed to Sarah J. McClain, Office of Clinical Standards and 
Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 
Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 
786-2994.
    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, C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, 
or you can call (410) 786-6954.

SUPPLEMENTARY 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 3-month 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 FDA-approved 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 eight 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 FDA-approved 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 Medicare-approved 
carotid stent facilities. All facilities listed meet CMS's standards 
for performing carotid artery stenting for high risk patients.

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 15250-7954, Telephone (202) 512-1800, Fax number 
(202) 512-2250 (for credit card orders); or National Technical 
Information Service, Department of Commerce, 5825 Port Royal Road, 
Springfield, VA 22161, Telephone (703) 487-4630.
    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: https://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,

[[Page 55865]]

Number 1 (January 2, 1994) forward. Free public access is available on 
a Wide Area Information Server (WAIS) through the Internet and via 
asynchronous dial-in. Internet users can access the database by using 
the World Wide Web; the Superintendent of Documents home page address 
is https://www.gpoaccess.gov/fr/, by using local WAIS client 
software, or by telnet to swais.gpoaccess.gov, then log in as guest (no 
password required). Dial-in users should use communications software 
and modem to call (202) 512-1661; type swais, then log in as guest (no 
password required).

C. Rulings

    We publish rulings on an infrequent basis. 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 https://cms.hhs.gov/rulings.

D. CMS' Compact Disk-Read Only Memory (CD-ROM)

    Our laws, regulations, and manuals are also available on CD-ROM 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 717-139-00000-3. The following material is on the CD-ROM 
disk:
     Titles XI, XVIII, and XIX of the Act.
     CMS-related 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, 1999. (Updated titles of the Social Security 
Laws are available on the Internet at https://www.ssa.gov/OP_Home/
ssact/comp-toc.htm.) The remaining portions of CD-ROM 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 CD-ROM. 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 CD-ROM.
    Any cost report forms incorporated in the manuals are included on 
the CD-ROM 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 NCD publication titled 
``Percutaneous Transluminal Angioplasty,'' use CMS-Pub. 100-03, 
Transmittal No. 33.


(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714, 
Medical Assistance Program)
    Dated: September 6, 2005.
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.

March 28, 2003 (68 FR 15196)
June 27, 2003 (68 FR 38359)
September 26, 2003 (68 FR 55618)
December 24, 2003 (68 FR 74590)
March 26, 2004 (69 FR 15837)
June 25, 2004 (69 FR 35634)
September 24, 2004 (69 FR 57312)
December 30, 2004 (69 FR 78428)
February 25, 2005 (70 FR 9338)
June 24, 2005 (70 FR 36620)

Addendum II--Description 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 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 III.--Medicare and Medicaid Manual Instructions
                        [April Through June 2005]
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   Transmittal  No.              Manual/Subject/Publication No.
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                      Medicare General Information
                           (CMS--Pub. 100-01)
------------------------------------------------------------------------
20....................  Medicare Authorization to Disclose Personal
                         Health Information Form and Information to Help
                         You Fill Out the Medicare Authorization to
                         Disclose Personal Health Information Form.
21....................  Removal of Medicare Number from Reimbursement
                         Checks.
22....................  Provider Extract File.
23....................  Procedures for Modifying Shared Systems Edits
                         and Capturing Audit Trail Data.
24....................  2005 Scheduled Release for July Updates to
                         Software Programs and Pricing/Coding Files.
-----------------------

[[Page 55866]]

 
                         Medicare Benefit Policy
                           (CMS--Pub. 100-02)
------------------------------------------------------------------------
31....................  List of Medicare Telehealth Services
                        Telehealth Services.
                        Payment for End-Stage Renal Disease-Related
                         Services as a Telehealth Service Originating
                         Site Facility Fee Payment (End-Stage Renal
                         Disease-Related Services).
32....................  This Transmittal is rescinded and replaced by
                         Transmittal 33.
33....................  Issued to a specific audience, not posted to the
                         Internet/Intranet due to the Confidentiality of
                         Instruction.
34....................  This Transmittal is rescinded and replaced by
                         Transmittal 36.
35....................  Automated Multi-Channel Chemistry for Continuous
                         Ambulatory Peritoneal Dialysis and Non-
                         Continuous Ambulatory Peritoneal Dialysis
                         Patients.
36....................  Pub. 100-02, Chapter 15, Section 220 and 230
                         Therapy Services.
                        Coverage of Outpatient Rehabilitation Therapy
                         Services (Physical Therapy, and Speech-Language
                         Pathology Services) Under Medical Insurance.
                        Conditions of Coverage and Payment for
                         Outpatient Physical Therapy, Occupational
                         Therapy or Speech-Language Pathology Services.
                        Outpatient Therapy Must be Under the Care of a
                         Physician/Non physician Practitioners (Orders/
                         Referrals and Need for Care).
                        Plans of Care for Outpatient Physical Therapy,
                         Occupational Therapy, or Speech-Language
                         Pathology Services.
                        Certification and Recertification of Need for
                         Treatment and Therapy Plans of Care.
                        Requirement that Services Be Furnished on an
                         Outpatient Basis.
                        Reasonable and Necessary Outpatient
                         Rehabilitation Therapy Services.
                        Practice of Physical Therapy, Occupational
                         Therapy, and Speech-Language Pathology.
                        Practice of Physical Therapy.
                        Practice of Occupational Therapy.
                        Practice of Speech-Language Pathology.
                        Services Furnished by a Physical or Occupational
                         Therapist in Private Practice.
                        Physical Therapy, Occupational Therapy, and
                         Speech-Language Pathology.
                        Services Provided Incident to the Services of
                         Physicians and Non-physician Practitioners.
                        Therapy Services Furnished Under Arrangements
                         with Providers and Clinics.
-----------------------
                Medicare National Coverage Determinations
                           (CMS--Pub. 100-03)
------------------------------------------------------------------------
31....................  Positron Emission Tomography (PET) for Brain,
                         Cervical, Ovarian, Pancreatic, Small Cell Lung,
                         and Testicular Cancers.
                        PET Scans.
                        PET for Perfusion of the Heart.
                        FDG PET for Lung Cancer.
                        FDG PET for Esophageal Cancer.
                        FDG PET for Colorectal Cancer.
                        FDG PET for Lymphoma.
                        FDG PET for Melanoma.
                        FDG PET for Head and Neck Cancers.
                        FDG PET for Myocardial Viability.
                        FDG PET for Refractory Seizures.
                        FDG PET for Breast Cancer.
                        FDG PET for Thyroid Cancer.
                        FDG PET for Soft Tissue Sarcoma.
                        FDG PET for Dementia and Neurodegenerative
                         Diseases.
                        FDG PET for Brain, Cervical, Ovarian,
                         Pancreatic, Small Cell Lung, and Testicular
                         Cancers.
                        FDG PET for All Other Cancer Indications Not
                         Previously Specified.
32....................  Autologous Stem Cell Transplantation.
                        Stem Cell Transplantation.
33....................  Percutaneous Transluminal Angioplasty.
34....................  Abarelix for the Treatment of Prostate Cancer.
35....................  Continuous Positive Airway Pressure Therapy for
                         Obstructive Sleep Apnea.
36....................  Smoking and Tobacco-Use Cessation Counseling.
37....................  Mobility Assistive Equipment.
                        Durable Medical Equipment Reference List.
38....................  Coverage of Colorectal Anti-Cancer Drugs
                         Included in Clinical Trials Anti-Cancer
                         Chemotherapy for Colorectal Cancer.
39....................  Cochlear Implantation.
40....................  Coverage of Aprepitant for Chemotherapy-Induced
                         Emesis.
41....................  Osteogenic Stimulators.
-----------------------
                       Medicare Claims Processing
                           (CMS Pub. 100--04)
------------------------------------------------------------------------
515...................  Update to 100-04 and Therapy Code Lists.
                        Health Common Procedure Coding System Coding
                         Requirement.
                        Part B Outpatient Rehabilitation and
                         Comprehensive Outpatient Rehabilitation.

[[Page 55867]]

 
                        Facility Services--General.
                        Discipline Specific Outpatient Rehabilitation
                         Modifiers--All Claims.
                        The Financial Limitation.
                        Reporting of Service Units With Health Common
                         Procedure Coding System--Form CMS-1500 and Form
                         CMS-1450.
516...................  Clarification for Outpatient Prospective Payment
                         System Hospitals Billing.
                        Initial Preventive Exam.
                        Outpatient Prospective Payment System Hospitals
                         Billing.
                        Advanced Beneficiary Notice as Applied to the
                         IPPE.
517...................  List of Medicare Telehealth Services.
                        Submission of Telehealth Claims for Distant Site
                         Practitioners.
                        Carrier Editing of Telehealth Claims.
518...................  This Transmittal is rescinded and replaced by
                         Transmittal 527.
519...................  This Transmittal is rescinded and replaced by
                         Transmittal 525.
520...................  Payment Policy Clarification Regarding the
                         Healthcare Common Procedure.
                        Coding System Q3001 Performed in an Ambulatory
                         Surgery Center.
521...................  Hemophilia Blood Clotting Factors.
                        Billing for Hemophilia Clotting Factors.
522...................  Issued to a specific audience, not posted to
                         Internet/Intranet due to Confidentiality of
                         Instruction.
523...................  Implementation of the Physician Scarcity Area
                         and Revision to the Health Professional
                         Shortage Area Payment to a Critical Access
                         Hospital.
524...................  Clarification to the Health Professional
                         Shortage Area Language in the Medicare Claims
                         Processing Manual.
                        Services Eligible for Health Professional
                         Shortage Area and Physician Scarcity Bonus
                         Payments.
525...................  Flu/PPV Revisions.
                        Billing Requirements.
                        Healthcare Common Procedural Coding System and
                         Diagnosis Codes.
                        Carrier Payment Requirements.
                        Roster Claims Submitted to Carriers for Mass
                         Immunization.
                        Centralized Billing for Flu and Pneumococcal
                         (PPV) Vaccines to Medicare.
                        Common Working File Edits.
                        Common Working File Edits on Carrier Claims.
526...................  Updated Requirements for Autologous Stem Cell
                         Transplantation.
                        Autologous Stem Cell Transplantation.
                        Billing for Stem Cell Transplantation.
                        Stem Cell Transplantation.
                        Health Common Procedure Coding System and
                         Diagnosis Coding Non-Covered Conditions.
527...................  New Coding for FDG PET Scans and Billing
                         Requirements for Specific.
                        Indications of Cervical Cancer.
                        Positron Emission Tomography Scans--General
                         Information.
                        Billing Instructions.
                        Use of Gamma Cameras and Full Ring and Partial
                         Ring Pet Scanners for Positron Emission
                         Tomography Scans.
                        Positron Emission Tomography Scan Qualifying
                         Conditions and Health.
                        Common Procedure Coding System/Common Procedural
                         Terminology Code Chart.
                        Appropriate Common Procedural Terminology Codes
                         Effective for Positron.
                        Emission Tomography Scan Services Performed on
                         or After January 28, 2005.
                        Expanded Coverage of Positron Emission
                         Tomography Scans for Breast Cancer Effective
                         for Services on or After October 1, 2002.
                        Coverage of Positron Emission Tomography Scans
                         for Thyroid Cancer.
                        Coverage of Positron Emission Tomography Scans
                         for Dementia and Neurodegenerative Diseases.
                        Billing Requirements for Positron Emission
                         Tomography Scans for Specific Indications of
                         Cervical Cancer for Services Performed on or
                         After January 28, 2005.
                        Billing Requirements for Positron Emission
                         Tomography Scans for Non-Covered Conditions.
528...................  July 2005 Quarterly Average Sales Price (ASP)
                         Medicare Part B Drug Pricing File, Effective
                         July 1, 2005.
529...................  Update to Current National Uniform Billing
                         Committee Codes.
                        General Instructions for Completion of Form CMS-
                         1450 for Billing.
530...................  Billing Requirements for Physician Services
                         Rendered in Method II Critical Access Hospital.
                        Payment for Inpatient Services Furnished by a
                         Critical Access Hospital.
                        Optional Method for Outpatient Services: Cost-
                         Based Facility Services Plus 115 Percent Fee
                         Schedule Payment for Professional Services.
                        Billing and Payment in a Physician Scarcity
                         Area.
531...................  Percutaneous Transluminal Angioplasty (Effective
                         March 17, 2005).
532...................  Abarelix for Treatment of Prostate Cancer.
533...................  Modification to the Common Working File (CWF)
                         Edit Process for Non-Assigned Medicaid
                         Coordination of Benefits Agreement (COBA)
                         Crossover Claims.
                        Consolidated Claims Crossover Process.
534...................  Changes to the Laboratory National Coverage
                         Determination Edit Software for July 2005.
535...................  Modification to Appeals Language on Medicare
                         Summary Notice.
                        Appeals Section.
                        Back of the Medicare Summary Notice--Carriers
                         and Intermediaries.
                        Carrier Spanish Medicare Summary Notice Back.
                        Intermediary Spanish MSN Back.

[[Page 55868]]

 
536...................  July Quarterly Update for 2005 Durable Medical
                         Equipment, Prosthetics, Orthotics & Supplies
                         Fee Schedule.
537...................  Instructions for Downloading the Medicare Zip
                         Code File.
538...................  New Waived Tests.
539...................  Expansion of Various Alpha and Numeric Fields
                         with in the Outpatient Prospective Payment
                         System Outpatient Code Editor.
540...................  Addition to Chapter 6 of the Claims Processing
                         Manual--Skilled Nursing Facility Inpatient Part
                         A Billing: SNF Prospective Payment System
                         Pricer Software.
                        Skilled Nursing Facility Prospective Payment
                         System Pricer Software Input/Output Record
                         Layout.
                        Skilled Nursing Facility Prospective Payment
                         System Rate Components Decision Logic Used by
                         the Pricer on Claims.
                        Annual Updates to the Skilled Nursing Facility
                         Pricer.
541...................  Correction to the use of Group Codes for The
                         Enforcement of Mandatory Electronic Submission
                         of Medicare Claims Enforcement.
542...................  Modification of Roster Billing for Mass
                         Immunizers Billing for Inpatient Part B
                         Services (Type of Bills 12x and 22x).
                        Claims Submitted to Intermediaries for Mass
                         Immunizations of Influenza and PPV.
543...................  Healthcare Provider Taxonomy Code Update.
544...................  Modification of FISS Edits for Colorectal Cancer
                         Screening Services (HCPCS Codes G0104, G0106,
                         G0107, G0120, and G0328) Furnished at Skilled
                         Nursing Facilities.
                        Common Working Files Edits.
545...................  The Teaching Adjustment for Inpatient
                         Psychiatric Facility Prospective Payment
                         System.
546...................  Number of Durable Medical Equipment Prosthetic,
                         Orthotic & Supplies Pricing Files That Must Be
                         Maintained Online for Medicare--Durable Medical
                         Equipment Regional Carrier, Fiscal Intermediary
                         and Regional Home Health Intermediary Only.
                        Online Pricing Files for Durable Medical
                         Equipment Prosthetic, Orthotics & Supplies.
547...................  This Transmittal is rescinded and replaced by
                         Transmittal 556.
548...................  New Healthcare Common Procedure Coding System
                         (HCPCS) Codes and Systems Edits for Supplies
                         and Accessories for Ventricular Assist Devices.
549...................  Update to the Place of Service Code Set to Add a
                         Code for Pharmacy Place of Service Codes and
                         Definitions.
550...................  Issued to a specific audience, not posted to
                         Internet/Intranet due to Confidentiality of
                         Instruction.
551...................  Dispensing/Supply Fee Code, Payment, and Common
                         Working File Editing for Immunosuppressive
                         Drugs.
                        Pharmacy Supplying Fee.
552...................  Changing the Order of Medicare System Edits
                         Affecting Hospice Claims.
                        Submitting Bills In Sequence for a Continuous
                         Inpatient Stay or Course of Treatment.
553...................  Expansion of State Codes for Office of Standard
                         & Certification Automated Retrieval System
                         Provider Numbers.
554...................  Issued to a specific audience, not posted to
                         Internet/Intranet due to Sensitivity of
                         Instruction.
555...................  Fiscal Intermediary Reporting of Add-on-Payments
                         That Do Not Result in a Specific Increase or
                         Decrease in the Amount Reported as Payable for
                         a Claim Or a Service on a Remittance Advice.
                        General Remittance Completion Requirements.
556...................  Revision to the Health Professional Shortage
                         Area and Physician Scarcity Area Payment Rules.
                        Services Eligible for Health Professional
                         Shortage Area and Physician Scarcity Bonus
                         Payments.
557...................  This Transmittal is rescinded and replaced by
                         Transmittal 566.
558...................  July Update to the 2005 Medicare Physician Fee
                         Schedule Database.
559...................  Override of Automated Health Professional
                         Shortage Area and/or Physician Scarcity Area
                         Bonus Payments for Globally Billed Services.
560...................  Issued to a specific audience, not posted to
                         Internet/Intranet due to Confidentiality of
                         Instruction.
561...................  New April 2005 Quarterly ASP Medicare Part B
                         Drug Pricing File and Revisions to January 2005
                         Quarterly ASP Medicare Part B Drug Pricing
                         File.
562...................  Smoking and Tobacco-Use Cessation Counseling
                         Services.
                        Health Common Procedure Coding System and
                         Diagnosis Coding.
                        Carrier Billing Requirements.
                        Fiscal Intermediary Billing Requirements.
                        Remittance Advice Notices.
                        Medicare Summary Notices.
                        Post-Payment Review for Smoking and Tobacco-Use
                         Cessation Counseling Services.
563...................  Quarterly Update to Correct Coding Initiative
                         (CCI) Edits, Version 11.2, Effective July 1,
                         2005.
564...................  July Update to the Medicare Outpatient Code
                         Editor (OCE) Version 20.3 for Bills From
                         Hospitals That Are Not Paid Under The
                         Outpatient Prospective Payment System.
565...................  This Transmittal is rescinded and replaced by
                         Transmittal 583.
566...................  This Transmittal is rescinded and replaced by
                         Transmittal 573.
567...................  Coverage of Colorectal Anti-Cancer Drugs
                         Included in Clinical Trials.
568...................  July Quarterly Update to 2005 Annual Update of
                         Health Common Procedure Codes System Codes Used
                         for Skilled Nursing Facility Consolidated
                         Billing Enforcement.
569...................  This Transmittal is rescinded and replaced by
                         Transmittal 572.
570...................  Common Working File: Addition of Disease
                         Management Auxiliary File.
571...................  This Transmittal is rescinded and replaced by
                         Transmittal 575.
572...................  July 2005 Outpatient Prospective Payment System
                         Code Editor Specifications Version 6.2.
573...................  Clarifying Manual Instructions for Coding and
                         Payment for Drug Administration Under the
                         Hospital Outpatient Prospective Payment System.
                        Billing and Payment for Drugs and Drug
                         Administration.
                        Coding and Payment for Drugs and Biologicals.
                        Separately Payable Drugs.
                        Packaged Drugs.
                        Pass-Through Drugs.
                        Non-Pass Through Drugs.

[[Page 55869]]

 
                        Coding and Payment for Drug Administration.
                        General.
                        Administration of Chemotherapy Drugs by
                         Infusion.
                        Administration of Chemotherapy Drugs by a Route
                         Other Than Infusion.
                        Administration of Non-Chemotherapy Drugs by
                         Infusion.
                        Administration of Non-Chemotherapy Drugs by a
                         Route Other Than Infusion.
                        Use of Modifier 59.
                        Billing for Infusion Hours.
574...................  Mobility Assistive Equipment.
575...................  New Remittance Advice Message for Referred
                         Clinical Diagnostic/Purchased Diagnostic
                         Service Duplicate Claims.
576...................  Correction to Chapter 17, Section 80.2.3, MSN/
                         ANSI X12N Denial Message for Anti-Emetic Drugs.
577...................  This Transmittal is rescinded and replaced by
                         Transmittal 594.
578...................  Update-Long Term Care Hospital Prospective
                         Payment System Rate Year 2006.
                        Provider Specific File.
                        Facility Level Adjustments.
                        Inputs/Outputs to Pricer.
579...................  Update to the National Council for Prescription
                         Drug Program Batch Standard 1.1 Billing Request
                         Companion Document.
580...................  New Healthcare Common Procedure Coding System
                         (HCPCS) Drug Codes.
581...................  This Transmittal is rescinded and replaced by
                         Transmittal 587.
582...................  New Remittance Advice (RA) Message for Referred
                         Clinical Diagnostic/Purchased Diagnostic
                         Service Duplicate Claims.
583...................  Access Process for HIPAA 270/271.
                        X12N Health Care Eligibility Benefit Inquiry and
                         Response 270/271.
                        Implementation.
                        Background.
                        Eligibility Workflow.
                        Health Care Claim Status Category Codes and
                         Health Care Codes for Use with The Health Care
                         Claim Status Request and Response ASC X12N 276/
                         277.
584...................  Update of Health Common Procedure Coding System
                         Codes and File Names, Descriptions and
                         Instructions for Retrieving the 2005 Ambulatory
                         Surgery Center Health Common Procedure Coding
                         System Additions, Deletions and Master Listing.
585...................  This Transmittal is rescinded and replaced by
                         Transmittal 599.
586...................  Modifications to the National Coordination of
                         Benefits Agreement File.
                        Transfer and Financial Reporting Processes.
                        Consolidation of the Claims Crossover Process.
                        Coordination of Benefits Agreement Detailed
                         Error Notification Process.
587...................  New Location for Contractor ID Number on
                         Medicare Summary Notices.
                        Title Section of the Medicare Summary Notice.
588...................  Coverage of Colorectal Anti-Cancer Drugs
                         Included in Clinical Trials.
589...................  Cochlear Implantation.
                        Billing Requirements for Expanded Coverage of
                         Cochlear Implantation.
                        Intermediary Billing Procedures.
                        Applicable Bill Types.
                        Special Billing Requirements for Intermediaries.
                        Intermediary Payment Requirements.
                        Carrier Billing Procedures.
                        Healthcare Common Procedural Coding System.
590...................  Aprepitant for Chemotherapy-Induced Emesis.
                        Oral Anti-Emetic Drugs Used as Full Replacement
                         for Intravenous Anti-Emetic.
                        Drugs as Part of a Cancer Chemotherapeutic
                         Regimen.
                        Health Common Procedure Coding System Codes for
                         Oral Anti-Emetic Drugs.
                        Billing and Payment Instructions for Fiscal
                         Intermediaries.
591...................  Medicare Contractor Annual Update of the
                         International Classification of Diseases, Ninth
                         Revision, Clinical Modification.
592...................  Social Security Administration Data for
                         Incarcerated Beneficiaries.
593...................  Disposition of Misdirected Claims to the
                         Carrier.
                        A Local Carrier Receives a Claim for a United
                         Mine Workers of America Beneficiary.
594...................  Preliminary Instructions: Expedited
                         Determinations/Reviews for Original Medicare.
                        Coordination With the Quality Improvement
                         Organization.
                        Limitation on Liability (LOL) Under Sec.   1879
                         Where Medicare Claims Are Disallowed.
                        Hospital-Issued Notices of Noncoverage.
                        Determining Beneficiary Liability in Claims for
                         Ancillary and Outpatient Services.
                        Application of Limitation on Liability to
                         Skilled Nursing Facility and Hospital Claims
                         for Services Furnished in Noncertified or
                         Inappropriately Certified Beds.
                        Determining Liability for Services Furnished in
                         a Noncertified Skilled Nursing Facility or
                         Hospital Bed.
595...................  This Transmittal is rescinded and replaced by
                         Transmittal 598.
596...................  Indian Health Service or Tribal Hospitals
                         Including Critical Access Hospital Payment
                         Methodology for Inpatient Social Admissions and
                         Outpatient Services Occurring During Concurrent
                         Stays.
597...................  Coverage and Billing for Ultrasound Stimulation
                         for Nonunion Fracture Healing Coverage
                         Requirements.
                        Intermediary Billing Requirements.
                        Bill Types.
                        Carrier and Intermediary Billing Instructions.
                        Durable Medical Equipment Regional Carrier
                         Billing Instructions.

[[Page 55870]]

 
598...................  Implementation of Carrier Guidelines for End
                         Stage Renal Disease.
                        Reimbursement for Automated Multi-Channel
                         Chemistry Tests.
                        (Supplemental to Change Request 2813).
                        Automated Multi-Channel Chemistry Tests for End
                         Stage Renal Disease.
                        Beneficiaries--Fiscal Intermediaries.
                        Claims Processing for Separately Billable Tests
                         for End Stage Renal Disease Beneficiaries.
599...................  July 2005 Update of the Hospital Outpatient
                         Prospective Payment System.
600...................  New Healthcare Common Procedure Coding System
                         Drug Codes.
-----------------------
                        Medicare Secondary Payer
                           (CMS--Pub. 100-05)
------------------------------------------------------------------------
28....................  Working Aged Exception for Small Employers in
                         Multi-Employer Group Health Plans.
29....................  Assignment of Non-Payment/Denial Code Specific
                         to the Recovery Audit Contractor Created Group
                         Health Plan Occurrences.
                        Identification of Recovery Audit Contractor
                         Created Group Health Plan Records.
30....................  Process to Address Freedom of Information and
                         Subpoena Requests.
                        Handling Freedom of Information and Subpoena
                         Duces Tecum Received In the Medicare Secondary
                         Payer Units .
-----------------------
                      Medicare Financial Management
                           (CMS--Pub. 100-06)
------------------------------------------------------------------------
67....................  Notice of New Interest Rate for Medicare
                         Overpayments and Underpayments.
68....................  Instructions for Affiliated Contractors Involved
                         in the Recovery Audit Contractor Demonstration.
                        Affiliated Contractor and Program Safeguard
                         Contractor Interaction with the Non-Medicare
                         Secondary Payer Recovery Audit Contractors.
                        Non-Medicare Secondary Payer Recovery Audit
                         Contractors.
                        Program Safeguard Contractor Communication with
                         the Recovery Audit Contractors.
                        Overview of the Recovery Audit Contractor
                         Process.
                        Full Program Safeguard Contractor Requirements
                         Surrounding Recovery.
                        Audit Contractor Non-Medicare Secondary Payer
                         Identification Process.
                        Providing Suppressed Cases to the Recovery Audit
                         Contractor Database.
                        Adjusting the Claim.
                        Disputing/Disagreeing with a Recovery Audit
                         Contractor Decision.
                        Handling Overpayment and Underpayments Resulting
                         from the Recovery.
                        Audit Contractor Findings.
                        Underpayments.
                        Setting up an Accounts Receivable.
                        Recoupments Received on a Recovery Audit
                         Contractor Initiated Overpayment.
                        Extended Repayments Received on a Recovery Audit
                         Contractor Initiated Overpayment.
                        Handling Appeals Resulting from Recovery Audit
                         Contractor Initiated Denials.
                        Referrals to the Department of Treasury.
                        Tracking Overpayments and Appeals.
                        Tracking Overpayments.
                        Tracking Appeals.
                        Reporting Administrative Costs Directly
                         Associated with the Recovery Audit.
                        Contractor Demonstration Project.
                        Potential Fraud.
                        Affiliated Contractor/Full Program Safeguard
                         Contractor Requirements.
                        Involving Recovery Audit Contractor Information
                         Dissemination.
                        Contacting Non-Responders.
                        Voluntary Refunds.
                        Working with the Recovery Audit Contractor
                         Evaluation Contractor.
69....................  Update to Debt Collection System (DCS) User
                         Guide .
-----------------------
                    Medicare State Operations Manual
                           (CMS--Pub. 100-07)
------------------------------------------------------------------------
06....................  Expansion of State Codes for OSCAR Provider
                         Numbers.
                        Provider Identification Number.
                        Home Health Agency Branch Identification
                         Numbers.
                        Outpatient Physical Therapy Extension
                         Identification Numbers.
07....................  This Transmittal is rescinded and replaced by
                         Transmittal 8.
08....................  Revision of Appendix PP--Section 483.25(d)--
                         Urinary Incontinence, Tags F315 and F316.
-----------------------
                       Medicare Program Integrity
                           (CMS--Pub. 100-08)
------------------------------------------------------------------------
107...................  Updated Chapter 1 to Reflect Changes in Program
                         Requirements.
                        Types of Claims for Which Contractors Are
                         Responsible.
                        Quality of Care Issues.

[[Page 55871]]

 
                        The Medicare Medical Review Program.
                        Goal of the Medical Review Program.
                        Medical Review Manager.
                        Annual Medical Review/Local Provider Education
                         Training Strategy.
                        Data Analysis and Information Gathering.
                        Problem Identification & Prioritization.
                        Intervention Planning.
                        Program Management.
                        Budget and Workload Management.
                        Staffing and Workforce Management.
                        Local Provider Education and Training Program.
                        Local Provider Education Training Activities.
                        One-on-One Provider Education.
                        Education Delivered to a Group of Providers.
                        Education Delivered via Electronic Media.
                        Description of Methods of Education.
                        Proactive Local Educational Meetings.
                        Comprehensive Educational Interventions.
                        Comparative Billing Report Education.
                        Frequently Asked Question Regarding Local
                         Education Issues.
                        Bulletin Articles/Advisories Regarding Local
                         Education Issues.
                        Scripted Response Documents on Local Education
                         Issues.
                        Local Provider Education Training Staff.
108...................  Change in Statistical Sampling Instructions.
                        General Purpose.
                        The Purpose of Statistical Sampling.
                        Steps for Conducting Statistical Sampling.
                        Determining When Statistical Sampling May be
                         Used.
                        Consultation With a Statistical Expert.
                        Use of Other Sampling Methodologies.
                        Probability Sampling.
                        Selection of Period for Review.
                        Defining the Universe, the Sampling Unit, and
                         the Sampling Frame.
                        Composition of the Universe.
                        The Sampling Unit.
                        Stratified Sampling.
                        Cluster Sampling.
                        Random Number Selection.
                        Determining Sample Size.
                        Documentation of Sampling Methodology.
                        Documentation of Universe and Frame.
                        Worksheets.
                        Informational Copies to GTL, Co-GTL, SME or CMS
                         RO.
                        The Point Estimate.
                        Actions Performed Following Selection of
                         Provider or Supplier and Sample.
                        Notification of Provider or Supplier of the
                         Review and Selection of the Review Site
                        Written Notification of the Review.
                        Determining Review Site.
109...................  Updated Standard System Changes for Provider
                         Enrollment Chain Ownership System and Multi-
                         Carrier System.
110...................  Revise CERT Shared Systems Modules to Retrieve
                         Claims Files Using Only Internal Control Number
                         as a Key.
111...................  Revising the Fiscal Intermediary Standard System
                         Shared System.
112...................  Requirement that Part B/Carriers Submit All
                         Provider Addresses to the Comprehensive Error
                         Rate Testing Program Contractor.
113...................  Shared System Maintainer Hours for PECOS
                         Problems and/or Implementation Changes.
114...................  Change in Statistical Sampling Instructions.
                        General Purpose.
                        The Purpose of Statistical Sampling.
                        Steps for Conducting Statistical Sampling.
                        Determining When Statistical Sampling May Be
                         Used.
                        Consultation With a Statistical Expert.
                        Use of Other Sampling Methodologies.
                        Probability Sampling.
                        Selection of Period for Review.
                        Defining the Universe, the Sampling Unit, and
                         the Sampling Frame.
                        Composition of the Universe.
                        The Sampling Unit.
                        Stratified Sampling.
                        Cluster Sampling......
                        Random Number Selection.
                        Determining Sample Size.
                        Documentation of Sampling Methodology.

[[Page 55872]]

 
                        Documentation of Universe and Frame.
                        Worksheets.
                        Informational Copies to GTL, Co-GTL, SME or CMS
                         RO.
                        The Point Estimate.
                        Actions Performed Following Selection of
                         Provider or Supplier and Sample.
                        Notification of Provider or Supplier of the
                         Review and Selection of the Review Site.
                        Written Notification of the Review.
                        Determining Review Site.
-----------------------
       Medicare Contractor Beneficiary and Provider Communications
                           (CMS--Pub. 100-09)
------------------------------------------------------------------------
09....................  Additions and Corrections to Provider Inquiry
                         and Provider Communications Program
                         Requirements.
10....................  This Transmittal is rescinded and replaced by
                         Transmittal 11.
11....................  FY 2005 Beneficiary Telephone Customer Services.
                        Beneficiary Services.
                        Guidelines for Beneficiary Telephone Services
                         (Activity Code 13005).
                        Toll Free Network Services.
                        Publication of Toll Free Numbers.
                        Call Handling Requirements.
                        Customer Service Assessment and Management
                         System Reporting Requirements.
                        Customer Service Representative Training.
                        Quality Call Monitoring.
                        Disclosure of Information (Adherence to the
                         Privacy Act and the Health Insurance
                         Portability and Accountability Act Privacy
                         Rule).
                        Second Level Screening of Beneficiary and
                         Provider Inquiries (Activity Code 13201).
                        Second Level Screening of Provider Inquiries
                         (Miscellaneous Code 13201/01).
                        Medicare Customer Service Next Generation
                         Desktop.
                        Publication Requests.
                        Medicare Participating Physicians and Suppliers
                         Directory.
                        Transfer of Part A Telephone/Written Inquiries
                         Workload.
                        Guidelines for Handling Beneficiary Written
                         Inquiries (Activity Code 13002).
                        Contractor Guidelines for High Quality Written
                         Responses to Inquiries Surveys.
                        Guidelines for High Quality Walk-In Services.
                        Customer Service Plans (Activity Code 13004).
                        Beneficiary Internet Web Sites.
-----------------------
                          Medicare Managed Care
                           (CMS--Pub. 100-16)
------------------------------------------------------------------------
00....................  None.
-----------------------
               Medicare Business Partners Systems Security
                           (CMS--Pub. 100-17)
------------------------------------------------------------------------
00....................  None
-----------------------
                             Demonstrations
                           (CMS--Pub. 100-19)
------------------------------------------------------------------------
22....................  Assignment of Non-Payment/Denial Code Specific
                         to the Recovery Audit Contractor Created Group
                         Health Plan Occurrences.
23....................  This Transmittal is rescinded and replaced by
                         25.
24....................  Instructions for Affiliated Contractors Involved
                         in the Recovery Audit Contractor Demonstration.
25....................  Low Vision Rehabilitation Demonstration.
-----------------------
                          One Time Notification
                           (CMS--Pub. 100-20)
------------------------------------------------------------------------
147...................  Medicare Health Insurance Portability &
                         Accountability Act Electronic Claims Report--
                         Second Reporting Timeframe Extension.
148...................  Revised Coding Guidelines for Drug
                         Administration Codes.
149...................  Requirements for Voided, Canceled, and Deleted
                         Claims.
150...................  Shared System Maintainer Hours for Resolution of
                         Problems Detected During Health Insurance
                         Portability and Accountability Act Transaction
                         Release Testing.
151...................  Common Working File Calculation of Next Eligible
                         Date for Preventive Services.
152...................  Issued to a specific audience, not posted to
                         Internet/Intranet due to Confidentiality of
                         Instruction.
153...................  This Transmittal is rescinded and replaced by
                         Transmittal 155.
154...................  Correction 2005 Clinical Laboratory Travel Fee
                         (P9603 P9604).
155...................  Payment to Ambulatory Surgery Centers for New
                         CPT Code 66711.
156...................  New Patient Status Code to Define Discharges or
                         Transfers to a Critical Access Hospital.
157...................  CD-ROM Initiative for Distribution of the Annual
                         Disclosure, ``Dear Doctor'' Letter and
                         Participation Enrollment Material.
158...................  Instructions for Fiscal Intermediaries to
                         Process Payment Adjustments Resulting from Data
                         Assessment and Verification Program Safeguard
                         Contractor Medical Review.

[[Page 55873]]

 
159...................  Requirements for Voided, Canceled, and Deleted
                         Claims.
160...................  Issued to a specific audience, not posted to
                         Internet/Intranet due to Confidentiality of
                         Instruction.
------------------------------------------------------------------------


                      Addendum IV.--Regulation Documents Published in the Federal Register
                                            [April through June 2005]
----------------------------------------------------------------------------------------------------------------
                               FR Vol. 70
      Publication date          Page No.    CFR Parts affected         File code           Title of regulation
----------------------------------------------------------------------------------------------------------------
April 1, 2005...............        16754  421 and 413........  CMS-1213-CN............  Medicare Program;
                                                                                          Prospective Payment
                                                                                          System for Inpatient
                                                                                          Psychiatric
                                                                                          Facilities;
                                                                                          Correction.
April 1, 2005...............        16720  403, 405, 410, 411,  CMS-1429-F2............  Medicare Program;
                                            414, 418