Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2008, 36596-36694 [E8-13110]

Agencies

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

[Federal Register Volume 73, Number 125 (Friday, June 27, 2008)]
[Notices]
[Pages 36596-36694]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13110]



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Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--January Through March 2008; Notice

Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / 
Notices

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9046-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--January Through March 2008

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 January 2008 through March 2008, 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 coverage-related guidance documents, 
and special one-time notices regarding national coverage provisions. 
Also included in this notice is a list of National Oncologic Positron 
Emissions Tomography Registry sites, a list of Medicare-approved 
ventricular assist device (destination therapy) facilities, a list of 
Medicare-approved lung volume reduction surgery facilities, a list of 
Medicare-approved clinical trials for fluorodeoxyglucose positron 
emissions tomography for dementia, and a list of Medicare-approved 
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 3-month time frame.

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, C4-26-05, 
7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call 
(410) 786-1864.
    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, C4-14-03, 7500 Security Boulevard, Baltimore, MD 
21244-1850, or you can call (410) 786-6954.
    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, C1-13-
04, 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 Melissa Musotto, Office 
of Strategic Operations and Regulatory Affairs, 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) 786-6962.
    Questions concerning Medicare-approved carotid stent facilities in 
Addendum VIII 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 Medicare's recognition of the American College 
of Cardiology-National 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, C1-09-06, 7500 
Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 
786-7205.
    Questions concerning Medicare's active coverage-related guidance 
documents in Addendum X may be addressed to Beverly Lofton, 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) 786-7136.
    Questions concerning one-time 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, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, 
or you can call (410) 786-7136.
    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, C1-09-06, 7500 Security Boulevard, 
Baltimore, MD 21244-1850, or you can call (410) 786-8564.
    Questions concerning Medicare-approved 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, C1-09-06, 7500 Security Boulevard, 
Baltimore, MD 21244-1850, or you can call (410) 786-7205.
    Questions concerning Medicare-approved 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, C1-09-06, 7500 Security Boulevard, 
Baltimore, MD 21244-1850, or you can call (410) 786-7205.
    Questions concerning Medicare-approved 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, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, 
or you can call (410) 786-9252.
    Questions concerning fluorodeoxyglucose positron emission

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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, C1-09-06, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-8564.
    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 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 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 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 one-time 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 Medicare-approved 
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 Medicare-approved 
facilities that are eligible to receive coverage for lung volume 
reduction surgery. Until May 17, 2007, facilities that participated in 
the National Emphysema Treatment Trial are also eligible to receive 
coverage.
     Addendum XV includes a listing of Medicare-approved 
facilities that meet minimum standards for facilities modeled in part 
on professional society statements on competency. All facilities

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must meet our standards in order to receive coverage for bariatric 
surgery procedures.
     Addendum XVI includes a listing of Medicare-approved 
clinical trials for fluorodeoxyglucose positron emission tomography 
(FDG-PET) 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 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, 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. 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 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, 2005. (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 Benefit Policy publication titled ``Erythropoiesis 
Stimulating Agents in Cancer and Related Neoplastic Conditions,'' use 
CMS-Pub. 100-03, Transmittal No. 80.

(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: June 4, 2008.
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 24, 2006 (71 FR 14903)
June 23, 2006 (71 FR 36101)
September 29, 2006 (71 FR 57604)
December 22, 2006 (71 FR 77202)
March 30, 2007 (72 FR 15282)
June 22, 2007 (72 FR 34508)
September 28, 2007 (72 FR 55282)
December 28, 2007 (72 FR 73990)
April 1, 2008 (73 FR 17422)

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

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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 January Through
                               March 2008
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       Transmittal No.              Manual/Subject/Publication No.
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             Medicare General Information (CMS-Pub. 100-01)
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00..........................  None.
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                Medicare Benefit Policy (CMS-Pub. 100-02)
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80..........................  Requirements for Ordering and Following
                               Orders for Diagnostic Tests Clinical
                               Laboratory Services; Requirements for
                               Ordering and Following Orders for
                               Diagnostic Tests Definitions;
                               Interpreting Physician Determines a
                               Different Diagnostic Test is Appropriate;
                               Rules for Testing Facility to Furnish
                               Additional Tests; Rules for Testing
                               Facility Interpreting Physician to
                               Furnish Different or Additional Tests;
                               Surgical/Cytopathology Exception.
81..........................  Process for Amending the List of Compendia
                               for Determination of Medically-Accepted
                               Indications for Off-Label Uses of Drugs
                               and Biologicals in an Anti-Cancer
                               Chemotherapeutic Regimen.
82..........................  January 2008 Update of the Hospital
                               Outpatient Prospective Payment System;
                               Manualization; Outpatient Hospital
                               Services; Limitations on Coverage of
                               Certain Services Furnished to Hospital
                               Outpatients; General Rule; Exception to
                               Limitation; Outpatient Defined; Encounter
                               Defined; Diagnostic Services Defined;
                               Coverage of Outpatient Diagnostic
                               Services; Outpatient Diagnostic Services
                               Under Arrangements; Diagnostic Services
                               Defined; Coverage of Outpatient
                               Diagnostic Services; Outpatient
                               Diagnostic Services Under Arrangements;
                               Outpatient Therapeutic Services;
                               Diagnostic Service Defined; Coverage of
                               Outpatient Diagnostic Services;
                               Outpatient Diagnostic Services Under
                               Arrangements; Outpatient Therapeutic
                               Services; Coverage of Outpatient
                               Therapeutic Services Incident to a
                               Physicians Service; Furnished on or After
                               August 1, 2000; Outpatient Observation
                               Services; Laboratory Services Furnished
                               to Nonhospital Patients by Hospital
                               Laboratory.
83..........................  Clinical Lab: New Automated Test for the
                               AMCC Panel Payment Algorithm Automated
                               Multi-Channel Chemistry Tests.
84..........................  Update to Audiology Policies; Audiological
                               Diagnostic Testing; Definition of
                               Qualified Audiologist.
85..........................  Psychological and Neuropsychological
                               Tests.
------------------------------------------------------------------------
       Medicare National Coverage Determination (CMS-Pub. 100-03)
------------------------------------------------------------------------
80..........................  Erythropoiesis Stimulating Agents in
                               Cancer and Related Neoplastic Conditions.
------------------------------------------------------------------------
              Medicare Claims Processing (CMS-Pub. 100-04)
------------------------------------------------------------------------
1405........................  SUBJECT: Reprocessing of Certain Hospital
                               Inpatient Prospective Payment System
                               Claims.
1406........................  January 2008 Quarterly Average Sales Price
                               Medicare Part B Drug Pricing Files and
                               Revisions to Prior Quarterly Pricing
                               Files.
1407........................  Outpatient Therapy Caps Without KX
                               Modifier Exceptions Start January 1, 2008
                               The Financial Limitation.
1408........................  Modification to the Model Medicare
                               Redetermination Notice (for Partly or
                               Fully Unfavorable Redeterminations);
                               Medicare Redetermination Notice (for
                               Partly or Fully Unfavorable
                               Redeterminations).
1409........................  Correction to Pub. 100-04, Chapter 17,
                               Section 100.2.1; CAP Required Modifiers.
1410........................  Annual Type of Service Update.
1411........................  April 2008 Update to the Medicare Code
                               Editor and Group.
1412........................  Reporting of Hematocrit or Hemoglobin
                               Levels on All Claims for the
                               Administration of Erythropoiesis
                               Stimulating Agents Implementation of New
                               Modifiers for Non-ESRD Indications, and
                               Reporting of Hematocrit/Hemoglobin Levels
                               on all Non-ESRD, Non-ESA Claims
                               Requesting Payment for Anti-Anemia Drugs;
                               Epoetin Alfa (EPO) Provided in the
                               Hospital Outpatient Department; Payment
                               for Aranesp in the Hospital Outpatient
                               Department; Reporting of Hematocrit and/
                               or Hemoglobin Levels; Required Modifiers
                               for ESAs As Administered to Non-ESRD
                               Patients; Hospitals Billing for EPO and
                               Darbepoetin Alfa (Aranesp) for Non-ESRD
                               Patients; The Competitive Acquisition
                               Program for Drugs and Biologicals Not
                               Paid on a Cost or Prospective Payments
                               Basis; Claims Processing Instructions for
                               CAP Claims for the Local Carriers; Items
                               14-33 Provider of Service or Supplier
                               Information.
1413........................  Erythropoiesis Stimulating Agents in
                               Cancer and Related Neoplastic Conditions;
                               Claims Processing Rules for ESAs
                               Administered to Cancer Patients for Anti-
                               Anemia Therapy.
1414........................  Outpatient Therapy Caps without KX
                               Modifier Exceptions Start January 1, 2008
                               The Financial Limitation.
1415........................  Additional Payable ``C'' Drug Codes for
                               January 1, 2008 in ASCs.
1416........................  Clarification of Bone Mass Measurement
                               Billing Requirements; Bone Mass
                               Measurements; Payment Methodology and
                               Healthcare Common Procedure Coding
                               Systems (HCPCS) Coding.
1417........................  January 2008 Update of the Hospital
                               Outpatient Prospective Payment System.
1418........................  New Healthcare Common Procedure Coding
                               System Modifiers when Billing for Patient
                               Care in Clinical Research Studies;
                               Carrier Specific Requirements for Certain
                               Specialties/Services; Billing
                               Requirements for Providers Billing
                               Routine Costs of Clinical Trials;
                               Involving a Category A Investigation
                               Device Exemptions; Billing Requirements
                               for Providers Billing Routine Costs of
                               Clinical Trials; Involving a Category B
                               Investigation Device Exemptions; Billing
                               Requirements for Clinical Trials;
                               Reserved for Future Use.
1419........................  January 2008 Integrated Outpatient Code
                               Specifications Version 9.0.
1420........................  Clarification Regarding the Coordination
                               of Benefits Agreement; Medigap Claim-
                               Based Crossover Process; Supplemental
                               Coverage/Medigap; COB Training Partner
                               and Medigap Plan Crossover Claim
                               Requirements; Patient and Insured
                               Information; MSN Messages; Coordination
                               of Benefits Agreement Medigap Claim-Based
                               Crossover Process.

[[Page 36600]]

 
1421........................  Update of Institutional Claims References;
                               Billing Form as Request for Payment;
                               Beneficiary Request for Payment on
                               Provider Record--UB-92 and Electronic
                               Billing (Part A and Part B); When an
                               Inpatient Admission May Be Changed to
                               Outpatient Status; Noncovered Charges on
                               Outpatient Bills; Line-Item Modifiers
                               Related to Reporting of Noncovered
                               Charges When Covered and Noncovered
                               Services Are on the Same Institutional
                               Claim; Form Prescribed by CMS In
                               Accordance with CMS Instructions;
                               Handling Incomplete or Invalid
                               Submissions; Payment Floor Standards;
                               Data Element Requirements Matrix; Claim
                               Change Reason Codes; Inpatient Part A
                               Hospital Adjustment Bills; (previously
                               130.3.1.2)--Tolerance Guides for
                               Submitting SNF Inpatient Adjustment
                               Request; (previously 130.3.3)--SNF
                               Inpatient Claim Adjustment Instructions;
                               (previously 130.3.4)--Patient Does Not
                               Return From SNF Leave of Absence, and
                               Last Bill Reported Patient Status as
                               Still Patient (30); Billing and Claims
                               Processing Requirements Related to HINNs;
                               Billing and Claims Processing
                               Requirements Related to Expedited
                               Determinations; Source of Admission--
                               Outpatient Hospital; Forms; DRG Grouper
                               Program; Payment to Hospitals and Units
                               Excluded from IPPS for Direct Graduate;
                               Medical Education and Nursing and Allied
                               Health (NandAH); Education for Medicare
                               Advantage Enrollees; Adjustment Bills;
                               Billing Requirements Under IRF PPS;
                               Shared Systems and CWF Edits; System
                               Edits; Benefits Exhausted; Completion of
                               the Uniform (Institutional Provider) Bill
                               (Form CMS-1450); Notice of Election for
                               RNHCI; Required Data Elements on Claims
                               for RNHCI Services; IPF PPS System Edits;
                               Where to Report Modifiers on the UB-92
                               (Form CMS-1450) and ANSI X12N Formats;
                               Optional Method for Outpatient Services:
                               Cost-Based Facility Services Plus 115;
                               Percent Fee Schedule Payment for
                               Professional Services; Bill Review for
                               Partial Hospitalization Services Provided
                               in Community Mental Health Centers; Line
                               Item Date of Service Reporting for
                               Partial Hospitalization; Line Item Date
                               of Service Reporting on Form CMS-1450;
                               Off-Site CORF Services; Notifying Patient
                               of Service Denial; Billing Skilled
                               Nursing Facility PPS Service; Input/
                               Output Record Layout; Leave of Absence;
                               Services in Excess of Covered Services;
                               Billing Formats; Billing; Calculation of
                               Case Mix Adjusted Composite Rate; In-
                               Facility Dialysis Bill Processing
                               Procedures; Required Information for In-
                               Facility Claims Paid Under the Composite
                               Rate; EPO Facility Billing Requirements;
                               Aranesp Facility Billing Requirements;
                               General Intermediary Bill Processing
                               Procedures for Method I Home Dialysis
                               Services; Required Billing Information
                               for Method I Claims; Billable Revenue
                               Codes Under Method II; Unbillable Revenue
                               Codes Under Method II; General Billing
                               Requirements; General Guidelines for
                               Processing Home Health Agency Claims;
                               Special Billing Situations Involving
                               OASIS Assessment; Heathcare Common
                               Procedure Coding System Coding
                               Requirements; Payment Methodology and
                               HCPCS Coding; General Billing Guidelines--
                               Intermediaries and Carriers; Intermediary
                               Guidelines; Hospital Billing Under Part
                               B; Billing and Payment Instructions for
                               Fiscal Intermediaries (FIs); Requirements
                               for Billing FIs for Immunosuppressive
                               Drugs; Claims Submitted to FIs for Mass
                               Immunizations of Influenza and
                               Pneumococcal Pneumonia Vaccine;
                               Healthcare Common Procedure Coding System
                               and Diagnosis Codes for Mammography
                               Services Diagnoses Codes; HHA
                               Recertification for Home Oxygen Therapy;
                               Billing/Claim Formats; ICD-9-CM Diagnosis
                               and Procedure Codes; Billing Requirements
                               for HBO Therapy for the Treatment of
                               Diabetic Wounds of the Lower Extremities;
                               Billing Requirements for Providers
                               Billing Category B IDEs.
1423........................  Summary of Policies in the 2008 Medicare
                               Physician Fee Schedule and the Telehealth
                               Originating Site Facility Fee Payment
                               Amount.
1424........................  Correction to Low Utilization Payment
                               Adjustment Add-on Payments Under the
                               Refined Home Health Prospective Payment
                               System; Composition of Health Insurance
                               Prospect Payment System Codes for Home
                               Health Prospective Payment System;
                               Request for Anticipated Payment; Home
                               Health Prospective Payment System Claims;
                               Input/Output Record Layout; Decision
                               Logic Used by the Pricer on RAPs;
                               Decision Logic Used by the Pricer on
                               Claims; Special Billing Situations
                               Involving OASIS Assessments; Temporary
                               Suspension of Home Health Services.
1425........................  Medicare Part A Skilled Nursing Facility
                               Prospective Payment System Pricer; Update
                               FY 2008 for 2 Core-Based Statistical
                               Areas with New Wage Index; Values--
                               Correction.
1426........................  Announcement of Medicare Rural Health
                               Clinics and Federally Qualified Health
                               Centers Payment Rate Increases; Payment
                               Rate for Independent and Provider Based
                               Rural Health Clinics and Federally
                               Qualified Health Clinics.
1427........................  New Value Code to Report Patient Prior
                               Payments.
1428........................  Issued to a specific audience, not posted
                               Internet/Intranet due to Confidentiality
                               of Instruction.
1429........................  Modification of Payment Window Edits in
                               the Common Working File to Look at Line
                               Item Dates of Service on Outpatient
                               Claims; Outpatient Services Treated as
                               Inpatient Services.
1430........................  Use of HCPCS V2787 When Billing Approved
                               Astigmatism-Correcting; Intraocular Lens
                               in Ambulatory Surgery Centers Physician
                               Offices, and Hospital Outpatient
                               Departments; Payment for Services and
                               Supplies; Coding and General Billing
                               Requirements.
1431........................  Update to the Implementation Date for Home
                               Health Agencies Providing Durable Medical
                               Equipment in Competitive Bidding Areas;
                               General Guidelines for Processing Home
                               Health Agency Claims; Home Health
                               Prospective Payment System Consolidated
                               Billing.
1432........................  Medicare Fee-for-Service Legacy Provider
                               IDs Prohibited on Form CMS-1500 and Form
                               CMS-1450 (UB-04) Claims; Carrier Data
                               Element Requirements; Item 14-3 Provider
                               of Service or Supplier Information.
1433........................  Smoking and Tobacco Use Cessation
                               Counseling BILLING CODE Update; Health
                               Common Procedure Coding System and
                               Diagnosis Coding; Carrier Billing
                               Requirements; FI Billing Requirements.
1434........................  Extension of the Dates of Service Eligible
                               for the Physician Scarcity Area; Bonus
                               Payment; Billing and Payment in a
                               Physician Scarcity Area; ZIP Code Files;
                               Billing and Payment in a Physician
                               Scarcity Area; Identifying Physician
                               Scarcity Area Locations.
1435........................  Emergency Update to the 2008 Medicare
                               Physician Fee Schedule Database.
1436........................  Modifications to the National Coordination
                               of Benefits Agreement; Crossover Process;
                               Consolidated Claims Crossover Process;
                               Consolidation of the Claims Crossover
                               Process; Coordination of Benefits
                               Agreement; Detailed Error Report
                               Notification Process.
1437........................  Change in the Amount in Controversy
                               Requirement for Administrative Law; Judge
                               Hearings and Federal District Court
                               Appeals; Right to an ALJ Hearing;
                               Requests for U.S. District Court Review
                               by a Party.
1438........................  Issued to a specific audience, not posted
                               to Internet/Intranet due to
                               Confidentiality of Instruction.
1439........................  Removal of Outdated References to
                               Christian Science Sanatoria from Medicare
                               Systems.
1440........................  Medicare, Medicaid, and State Children's
                               Health Insurance Program Extension Act of
                               2007 Changes to Independent Laboratory
                               Billing for the Technical Component of
                               Physician Pathology Services; Technical
                               Component of Physician Pathology;
                               Hospital Patients.
1441........................  New ``K'' Code for Replacement Interface
                               Material.
1442........................  Issued to a specific audience, not posted
                               to Internet/Intranet due to
                               Confidentiality of Instruction.

[[Page 36601]]

 
1443........................  Home Health Prospective Payment System
                               Refinement and Rate; Update for Calendar
                               Year 2008; Basis of Medicare Prospective
                               Payment Systems and Case-Mix.
1444........................  Modification to Existing Medicare Summary
                               Notice Procedures; Regarding the MSN
                               Customer Service Information Box,
                               Beneficiary Estate Information and the
                               Appeals Address; Title Section of the MSN
                               Appeals Section; Title Section.
1445........................  January 2008 Update of the Hospital
                               Outpatient Prospective Payment System;
                               Manualization; Payment Status Indicators;
                               APC Payment Groups; Composite APCs;
                               Calculation of APC Payment Rates;
                               Packaging; Combinations of Packaged
                               Services of Different Types That Are
                               Furnished on the Same Date of Service;
                               Discounting; Payment Adjustments; Outlier
                               Adjustments; Calculation of Overall Cost
                               to Charge Ratios for Hospitals; Paid
                               Under the Outpatient Prospective Payment
                               System and Community Mental Health
                               Centers Paid Under the Hospital;
                               Requirement to Calculate CCRs for
                               Hospitals Paid Under OPPS and for CMHC
                               Circumstances in Which CCRs Are Used;
                               Selection of the CCR To Be Used; Mergers,
                               Acquisitions, and Other Ownership
                               Changes; New Providers and Providers with
                               Cost Report Periods Less Than a Full
                               Year; Substitution of Statewide CCRs for
                               Extreme OPPS Hospital Specific CCRs;
                               Methodology for Calculation of Hospital
                               Overall CCR for Hospitals That Do Not
                               Have Nursing and Paramedical Education
                               Programs; Methodology for Calculation of
                               Hospital Overall CCR for Hospitals That
                               Have Nursing and Paramedical Education
                               Programs; Methodology for Calculation of
                               CCR for CMHCs; Location of Statewide
                               CCRs, Tolerances for Use of Statewide
                               CCRs in Lieu of Calculated CCRs, and Cost
                               Centers To Be Used in the Calculation of
                               CCRs; Reporting of CCRs for Hospitals
                               Paid Under OPPS and for CMHCs; Packaged
                               Revenue Codes; Revenue Codes for
                               ``Sometimes Therapy'' Services; Use of
                               Modifiers for Discontinued Services; OPPS
                               Coinsurance; Outpatient Pricer;
                               Outpatient Provider Specific File;
                               Changes to the OPPS Pricer Logic
                               Effective January 1, 2003; Billing for
                               Devices Under the OPPS; Billing and
                               Payment for Brachytherapy Sources;
                               Billing for Brachytherapy Sources--
                               General; Definition of Brachytherapy
                               Source for Separate Payment; Billing of
                               Brachytherapy Sources Ordered for a
                               Specific Patient; Billing for
                               Brachytherapy Source Supervision,
                               Handling, and Loading Costs; Transitional
                               Outpatient Payments for CY 2006-CY 2008;
                               Clinic and Emergency Visits; Critical
                               Care Services; Special Services for OPPS
                               Billing; Billing for Corneal Tissue;
                               Hospital Services For Patients with End-
                               Stage Renal Disease; Billing Codes for
                               Intensity Modulated Radiation Therapy and
                               Stereotactic; Billing for IMRT Planning
                               and Delivery; Additional Billing
                               Instructions for IMRT Planning; Billing
                               for Multi-Source Photon (Cobalt 60-Based)
                               Stereotactic Radiosurgery; Planning and
                               Delivery; Billing for Linear Accelerator
                               (Robotic Image-Guided and Non-Robotic
                               Image-Guided) SRS Planning and Delivery;
                               Billing for Amniotic Membrane; Billing
                               and Payment for Cardiac Rehabilitation
                               Services; Billing and Payment for Alcohol
                               and/or Substance Abuse Assessment and
                               Intervention Services; Billing for
                               Cardiac Echocardiography Services;
                               Cardiac Echocardiography Without
                               Contrast; Cardiac Echocardiography With
                               Contrast; Billing for Nuclear Medicine
                               Procedures; Coding and Payment for Drugs,
                               Biologicals, and Radiopharmaceuticals;
                               Coding and Payment for Drug
                               Administration; Observation Services
                               Overview; Reporting Hours of Observation;
                               Billing and Payment for 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 Admission to
                               Observation 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 Furnished on or
                               After January 1, 2008; Billing and
                               Payment for Observation Services
                               Beginning January 1, 2008; Billing and
                               Payment for Direct Admission to
                               Observation Care Beginning January 1,
                               2008; Services Not Covered as Observation
                               Services; Hospital Billing Under Part B;
                               Payment Rules for Drugs and Biologicals;
                               Drugs, Biologicals, and
                               Radiopharmaceuticals.
1446........................  Update to Common Working File (CWF Edits)
                               7284 and 7548; Indian Health Service/
                               Tribal Hospital Inpatient Social Admits;
                               FI--Social Admissions.
1447........................  Reporting of Additional Data To Describe
                               Services on Hospice Claims; Levels of
                               Care; Data Required on Claim to FI.
1448........................  Adjudicating Claims for Immunosuppressive
                               Drugs When Medicare Did Not Pay for the
                               Original Transplant; Billing for
                               Immunosuppressive Drugs.
1450........................  Update to the Common Working File to Allow
                               the Posting of Skilled Nursing Facility
                               and Swing Bed Claims to the Beneficiary's
                               Spell of Illness When Qualifying Stay
                               Criteria Are Not Met; Billing When
                               Qualifying Stay or Transfer Criteria Are
                               Not Met.
1451........................  Clinical Lab: New Automated Test for the
                               AMCC Panel Payment Algorithm; Organ or
                               Disease Oriented Panel.
1452........................  Instructions for Downloading the Medicare
                               ZIP Code File for July 2008.
1453........................  Systems Changes for Prescription Order
                               Numbers for the Competitive Acquisition
                               Program for Part B Drugs and Biologicals;
                               Submitting the Prescription Order Numbers
                               and No Pay Modifiers; Further Editing on
                               the Prescription Order Number; Carrier
                               Specific Requirements for Certain
                               Specialties/Services.
1454........................  Department of Veterans Affairs Claims
                               Adjudication Services Project--New IOM
                               Chapter--Pub. 100-04, Chapter 37
                               ``Department of Veterans Affairs Claims
                               Adjudication Services Project'';
                               Background on the Veterans Affairs Claims
                               Adjudication Services Project;
                               Requirements for Processing Veterans
                               Affairs Claims; Department of Veterans
                               Affairs Claims Adjudication: Coinsurance
                               and Deductible; Generating Unsolicited
                               Responses to the Veterans Affairs; Use of
                               Legacy Provider Numbers After National
                               Provider Identifiers Are Fully
                               Implemented.
1455........................  Part B Drug Competitive Acquisition
                               Program Quarterly Drug List Update.
1456........................  Manualization of Payment for Outpatient
                               End-Stage Renal Disease-Related Services;
                               Monthly Capitation Payment Method for
                               Physicians' Services Furnished to
                               Patients on Maintenance Dialysis; Payment
                               for End-Stage Renal Disease-Related
                               Services Under the Monthly Capitation
                               Payment; (Center-Based Patients); Payment
                               for Managing Patients on Home Dialysis;
                               Patients Who Switch Modalities (Center to
                               Home and Vice Versa); Payment for End-
                               Stage Renal Disease-Related Services (Per
                               Diem); Guidelines for Physician or
                               Practitioner Billing (Per Diem); Data
                               Required on Claim for Monthly Capitation
                               Payment; Controlling Claims Paid Under
                               the Monthly Capitation Payment Method.
1457........................  Redeterminations of Overpayments; The
                               Redetermination.
1458........................  Teaching Physician Requirements for End-
                               Stage Renal Disease Monthly; Capitation
                               Payment; Miscellaneous.
1459........................  Comprehensive Outpatient Rehabilitation
                               Facility Billing Requirement; Updates for
                               Fiscal Year 2008; Allowable Revenue Codes
                               on Comprehensive Outpatient
                               Rehabilitation Facility; 75x Bill Types;
                               Proper Reporting of Nursing Services by
                               CORFS--FIs; Payment of Drugs,
                               Biologicals, and Supplies in a
                               Comprehensive Outpatient Rehabilitation
                               Facility; Billing for Social Work and
                               Psychological Services in a Comprehensive
                               Outpatient Rehabilitation Facility;
                               Billing for Respiratory Therapy Services
                               in a Comprehensive Outpatient
                               Rehabilitation Facility; FI Payment for
                               Pneumococcal Pneumonia Virus, Influenza
                               Virus, and Hepatitis B; Virus Vaccines
                               and Their Administration.
1460........................  Subsequent Hospital Visits and Hospital
                               Discharge Day Management Services (Codes
                               99231--99239).

[[Page 36602]]

 
1461........................  Clarification to CR 5744--Payment
                               Allowance Update for the Influenza Virus
                               Vaccine CPT 90660 and Further Instruction
                               Regarding the Pneumococcal Vaccine CPT
                               90669; Healthcare Common Procedure Coding
                               System and Diagnosis Codes.
1462........................  Healthcare Provider Taxonomy Codes Update
                               April 2008.
1463........................  ZIP Code Files by Date of Service; Claims
                               Processing Instructions for Payment
                               Jurisdiction for Claims Received on or
                               after April 1, 2004; Transition Overview.
1464........................  Quarterly Update to Correct Coding
                               Initiative (CCI) Edits, Version 14.1,
                               Effective April 1, 2008.
1465........................  Payment for Initial Hospital Care Services
                               (Codes 99221-99233) and Observation or
                               Inpatient Care Services (Including
                               Admission and Discharge Services) (Codes
                               99234-99236).
1466........................  Payment for Hospital Observation Services
                               (Codes 99217-99220) and Observation or
                               Inpatient Care Services (Including
                               Admission and Discharge Services--Codes
                               99234-99236).
1467........................  Modification to Existing Medicare Summary
                               Notice Procedures Regarding the Customer
                               Service Information Box; Title Section of
                               the Medicare Summary Notice; Appeals
                               Section.
1468........................  Claim Status Category Code and Claim
                               Status Code Update.
1469........................  Document Control Number Search Feature.
1470........................  Update to Audiology Policies; Audiological
                               Diagnostic Tests, Speech-Language
                               Evaluations and Treatments.
1471........................  Healthcare Common Procedure Coding System
                               Codes Subject to and Excluded from
                               Clinical Laboratory Improvement
                               Amendments Edits.
1472........................  Update of Institutional Claims References;
                               Billing Form as Request for Payment;
                               Beneficiary Request for Payment on
                               Provider Record--UB-04 and Electronic
                               Billing (Part A and Part B); When an
                               Inpatient Admission May Be Changed to
                               Outpatient Status; Noncovered Charges on
                               Outpatient Bills; Line-Item Modifiers
                               Related to Reporting of Noncovered
                               Charges; When Covered and Noncovered
                               Services Are on the Same Institutional
                               Claim Form Prescribed by CMS In
                               Accordance with CMS Instructions;
                               Handling Incomplete or Invalid
                               Submissions; Payment Floor Standards;
                               Data Element Requirements Matrix; Claim
                               Change Reason Codes; Inpatient Part A
                               Hospital Adjustment Bills; Tolerance
                               Guides for Submitting SNF Inpatient
                               Adjustment Requests; SNF Inpatient Claim
                               Adjustment Instructions; Patient Does Not
                               Return From SNF Leave of Absence, and
                               Last Bill Reported; Patient Status as
                               Still Patient (30); Billing and Claims
                               Processing Requirements Related to HINNs;
                               Billing and Claims Processing
                               Requirements Related to Expedited
                               Determinations; Data Element Requirements
                               Matrix (FI); Source of Admission--
                               Outpatient Hospital; Forms; DRG GROUPER
                               Program; Payment to Hospitals and Units
                               Excluded from IPPS for Direct Graduate
                               Medical Education and Nurs