[Federal Register Volume 69, Number 250 (Thursday, December 30, 2004)]
[Notices]
[Pages 78428-78442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28156]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9024-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--July 2004 Through September 2004
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 July 2004 through September 2004, 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. Finally, this notice also
includes listings of all approval numbers from the Office of Management
and Budget for collections of information in CMS regulations.
Section 1871(c) of the Social Security Act requires that we publish
a list of
[[Page 78429]]
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 Eileen Davidson, 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) 786-6874.
Questions concerning approval numbers for collections of
information in Addendum VII may be addressed to Dawn Willinghan, Office
of Strategic Operations and Regulatory Affairs, Regulations Development
and Issuances Group, Centers for Medicare & Medicaid Services, C5-09-
26, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call
(410) 786-6141.
Questions concerning all other information may be addressed to
Margaret Teeters, Office of Strategic Operations and Regulatory
Affairs, Regulations Development Group, Centers for Medicare & Medicaid
Services, C5-13-18, 7500 Security Boulevard, Baltimore, MD 21244-1850,
or you can call (410) 786-4678.
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 six 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.
III. How to Obtain Listed Material
A. Manuals
Those wishing to subscribe to program manuals should contact either
the Government Printing Office (GPO)
[[Page 78430]]
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: http://cms.hhs.gov/manuals/default.asp.
B. Regulations and Notices
Regulations and notices are published in the daily Federal
Register. Interested individuals may purchase individual copies or
subscribe to the Federal Register by contacting the GPO at the address
given above. When ordering individual copies, it is necessary to cite
either the date of publication or the volume number and page number.
The Federal Register is also available on 24x microfiche and as an
online database through GPO Access. The online database is updated by 6
a.m. each day the Federal Register is published. The database includes
both text and graphics from Volume 59, Number 1 (January 2, 1994)
forward. Free public access is available on a Wide Area Information
Server (WAIS) through the Internet and via asynchronous dial-in.
Internet users can access the database by using the World Wide Web; the
Superintendent of Documents home page address is http://www.gpoaccess.gov/fr/index.html, by using local WAIS client software,
or by telnet to 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 http://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 http://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 National Coverage
Determinations publication titled ``Islet Cell Transplantation,'' use
CMS-Pub. 100-03, Transmittal No. 18.
(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: December 13, 2004.
Jacquelyn Y. White,
Director, Office of Strategic Operations and Regulatory Affairs.
Addendum I
This addendum lists the publication dates of the most recent
quarterly listings of program issuances.
June 28, 2002 (67 FR 43762)
September 27, 2002 (67 FR 61130)
December 27, 2002 (67 FR 79109)
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)
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.
[[Page 78431]]
Addendum III.--Medicare and Medicaid Manual Instructions July Through
September 2004
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Transmittal No. Manual/Subject/Publication Number
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Medicare General Information (CMS-Pub. 100-01)
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08................................... Standard Terminology for Claims
Processing Systems Standard
Terminology Chart.
09................................... Transmittal rescinded and
replaced with Transmittal 10.
10................................... Update to Medicare Deductible,
Coinsurance and Premium Rates
for Calendar Year 2005.
Basis for Determining the Part A
Coinsurance Amounts.
Part B Annual Deductible.
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Medicare Benefit Policy (CMS-Pub. 100-02)
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18................................... This revision rescinded
Transmittal 12.
19................................... Hospital Services Covered Under
Part B Outpatient Observation
Services.
20................................... This revision rescinded
Transmittal 17.
21................................... Medicare Comprehensive Outpatient
Rehabilitation Facility
Coverage.
Comprehensive Outpatient
Rehabilitation Facility Services
Provided by Medicare.
Required Services.
Optional Comprehensive Outpatient
Rehabilitation Facility
Services.
Rules for Provision of Services.
Physician's Services.
Physical Therapy Services.
Occupational Therapy Services.
Speech-Language Pathology
Services.
Respiratory Therapy Services.
Prosthetic and Orthotic Devices
and Supplies.
Social Services.
Psychological Services.
Nursing Services.
Drugs and Biologicals.
Home Environment Evaluation.
Outpatient Mental Health
Treatment Limitation.
22................................... This revision rescinded
transmittal 15.
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Medicare National Coverage Determinations (CMS-Pub. 100-03)
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17................................... Manualization of the Negotiated
Clinical Diagnostic Laboratory
National Coverage
Determinations.
Urine Culture, Bacterial.
Human Immunodeficiency Virus
Testing (Prognosis Including
Monitoring).
Human Immunodeficiency Virus
Testing (Diagnosis).
Blood Counts.
Partial Thromboplastin Time.
Prothrombin Time.
Serum Iron Studies.
Collagen Crosslinks, Any Method.
Blood Glucose Testing.
Glycated Hemoglobin/Glycated
Protein.
Thyroid Testing.
Lipid Testing.
Digoxin Therapeutic Drug Assay.
Alpha-fetoprotein.
Carcinoembryonic Antigen.
Human Chorionic Gonadotropin.
Tumor Antigen by Immunoassay.
Prostate Specific Antigen.
Gamma Glutamyl Transferase.
Hepatitis Panel/Acute Hepatitis
Panel.
Fecal Occult Blood Test.
18................................... Islet Cell Transplantation.
Pancreas Transplants (Effective
July 1, 1999).
Islet Cell Transplantation in the
Context of a Clinical Trial
(Effective October 1, 2004).
19................................... Blood-Derived Products for
Chronic Non-Healing Wounds.
20................................... Issued to a specific audience,
not posted to Internet/Intranet
due to sensitivity of
Instruction.
21................................... Magnetic Resonance Spectroscopy
for Diagnosing Brain Tumors.
Magnetic Resonance Imaging.
Magnetic Resonance Spectroscopy.
Magnetic Resonance Angiography.
--------------------------------------
Medicare Claims Processing (CMS-Pub. 100-04).
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222.................................. Skilled Nursing Facility
Consolidated Billing
Requirements for Durable Medical
Equipment Prosthetic, Orthotics
& Supplies.
Skilled Nursing Facility
Consolidated Billing and Durable
Medical Equipment Provided by
Durable Medical Equipment
Prosthetic, Orthotics & Supplies
Suppliers.
General Information.
[[Page 78432]]
223.................................. Positron Emissions Tomography
Scans and Related Claims
Processing.
Positron Emission Tomography
Scans--General Information.
Billing Instructions.
Use of Gamma Cameras and Full
Ring and Partial Ring Positron
Emissions Scanners.
Positron Emission Tomography Scan
Qualifying Conditions and
Health.
Common Procedure Coding System
Code Chart.
Positron Emissions Tomography
Scans for Imaging of the
Perfusion of the Heart Using
Rubidium 82.
Expanded Coverage of Positron
Emission Tomography Scans for
Solitary Pulmonary Nodules.
Expanded Coverage of Positron
Emissions Tomography Scans
Effective for Services on or
after July 1, 1999.
Expanded Coverage of Positron
Emissions Tomography Scans
Effective for Services on or
after July 1, 2001.
Expanded Coverage of Positron
Emissions Tomography Scans for
Breast Cancer Effective for
Dates on or after October 1,
2002.
Coverage of Positron Emissions
Tomography Scans for Myocardial
Viability.
Coverage of Positron Emissions
Tomography Scans for Thyroid
Cancer.
Coverage of Positron Emissions
Tomography Scans for Perfusion
of the Heart Using Ammonia N-13.
224.................................. October Quarterly Update to 2004
Annual Update of Health Common
Procedure Coding System Codes
Used For Skilled Nursing
Facility.
Consolidated Billing Enforcement.
225.................................. Changes to the Laboratory
National Coverage Determination
Edit Software for October 2004.
226.................................. Quarterly Update of Health Common
Procedure Coding System Codes
Used for Home Health
Consolidated Billing
Enforcement.
Home Health Prospective Payment
System Consolidated Billing and
Primary Home Health Agency.
227.................................. Local Medical Review Policy/Local
Coverage Determination Medicare.
Summary Notice Message Revision.
Medical Necessity.
Necesidad M[eacute]dica.
228.................................. General Policy.
Patient and Insured Information.
229.................................. Additional Clarification of Bill
Type 22x and 23x Submitted by
Skilled Nursing Facilities With
Instructions for Involuntarily
Moving A Beneficiary Out of the
Skilled Nursing Facility and
Ending a Benefit Period.
Skilled Nursing Facility
Prospective Payment System and
Consolidated Billing Overview.
Consolidated Billing Requirements
for Skilled Nursing Facility.
Other Excluded Services Beyond
the Scope of a Skilled Nursing
Facility Part A Benefit.
Outpatient Surgery and Related
Procedures `` Inclusions.
Emergency Services.
Dialysis and Dialysis Related
Services to a Beneficiary With
End Stage Renal Disease.
End Stage Renal Disease Services.
Coding Applicable to Epoetin
Services.
Coding for Darbepoetin Alfa.
Ambulance Services.
Screening and Preventive
Services.
Therapy Services.
Situations that Require a
Discharge or Leave of Absence.
Billing Procedures for Periodic
Interim Payment Method of
Payment Ending A Benefit Period.
Other Billing Situations.
Billing for Outpatient Skilled
Nursing Facility Services
230.................................. Update to the Claims Status
Codes.
Health Care Claims Status
Category Codes and Health Care
Claims Status Codes for Use with
Health Care Claims Status
Request and Response.
231.................................. Indian Health Service or Tribal
Critical Access Hospital Payment
Methodology for Inpatient and
Outpatient Services.
Payment for Inpatient Services
Furnished by an Indian Health
Service or Tribal Critical
Access Hospital.
Payment for Outpatient Services
Furnished by an Indian Health
Service or Tribal Critical
Access Hopsital.
232.................................. Issued to a specific audience,
not posted to Internet/Intranet
due to confidentiality of
instruction.
233.................................. Issued to a specific audience,
not posted to Internet/Intranet
due to confidentiality of
instruction.
234.................................. Standardized Responses to
Provider Inquiries Regarding the
Negotiated Laboratory National
Coverage Determinations Edit
Software.
235.................................. Instructions for Downloading the
Medicare Zip Code File.
236.................................. 2005 Durable Medical Equipment
Prosthetic, Orthotics & Supplies
Pricing.
File Record Layout Expansion and
New Pricing Procedures for
Certain Durable Medical
Equipment Prosthetic, Orthotics
& Supplies Items Based on
Modifiers.
Payment of Durable Medical
Equipment Prosthetic, Orhtotics
& Supplies Items based on
Modifiers.
Intermediary Format for Durable
Medical Equipment, Prosthetic,
Orthotic and Supply Fee
Schedule.
237.................................. Implementation of Patient Status
Code 65, Discharged/Transferred
to a Psychiatric Hospital or
Psychiatric Distinct Part Unit
of a Hospital.
238.................................. Health Insurance Portability and
Accountability Act Institutional
Health Care Claim Implementation
Guide Additional Updates.
239.................................. Transmittal 239 is Rescinded and
replaced with Transmittal 270.
240.................................. Expansion of the Existing
Interrupted Stay Policy Under
Long Term Care.
Hospital Prospective Payment
System.
241.................................. Processing Part B Claims for
Indian Health Services.
General.
Services That May Be Paid to
Indian Health Service/Tribe/
Tribal Organization Facilities.
[[Page 78433]]
Services Paid Under the Physician
Fee Schedule.
Other Part B Services.
Durable Medical Equipment.
Prosthetics and Orthotics.
Prosthetics Devices.
Surgical Dressings and Splints
and Casts.
Therapeutic Shoes.
Drugs.
Clinical Laboratory Services.
Ambulance Services.
Claims Processing.
Claims Processing Requirements
for Benefits, Improvements &
Protection Act of 2000 Services.
Claims Processing Requirements
for Medicare Modernization Act
Enrollment and Billing for
Durable Medical Equipment,
Prosthetic, Orthotics &
Supplies.
Claims Processing for Durable
Medical Equipment, Prosthetic,
Orthotics & Supplies.
Enrollment for Durable Medical
Equipment, Prosthetic, Orthotics
& Supplies.
Claims Submission for Durable
Medical Equipment, Prosthetic,
Orthotics & Supplies.
Enrollment and Billing for
Clinical Laboratory and
Ambulance Services Claims
Submission and Processing for
Clinical Laboratory and
Ambulance Service.
Enrollment for Clinical
Laboratory and Ambulance
Services and Part B drugs.
242.................................. Quarterly Update to Correct
Coding Initiative edits, Version
10.3, Effective October 1, 2004.
243.................................. Patient Status Code and Reason
for Patient Visit for the
Hospital Outpatient Prospective
Payment System.
Patient Status Code and Reason
for Patient Visit for the
Hospital.
244.................................. Transmittal 244 is Rescinded and
Replaced with Transmittal 269.
245.................................. Issued to a specific audience,
not posted to Internet/Intranet
due to confidentiality of
instruction.
246.................................. Issued to a specific audience,
not posted to Internet/Intranet
due to confidentiality of
instruction.
247.................................. Issued to a specific audience,
not posted to Internet/Intranet
due to confidentiality of
instruction.
248.................................. Durable Medical Equipment
Regional Carrier/Local Carriers/
Statistical Analysis Durable
Medical Equipment Regional
Carrier--Drug Pricing Limits as
of January 1, 2005.
Payment Rules for Drugs and
Biologicals.
Medicare Modernization Act Drug
Pricing-Average Sales Price.
Single Drug Pricer.
Calculation of the Payment
Allowance Limit for Durable
Medical Equipment.
Regional Carrier Drugs.
Calculation of the Average
Wholesale Price.
Detailed Procedures for
Determining Average Wholesale
Price and the Drug.
Payment Allowance Limits.
Background.
Review of Sources for Medicare
Covered Drugs and Biologicals.
Use of Generics.
Find the Strength and Dosage.
Restrictions.
Inherent Reasonableness for Drugs
and Biologicals.
Injection Services.
Injections Furnished to End Stage
Renal Disease Beneficiaries.
249.................................. New Medicare Summary Notice
Message 31.18.
Adjustments.
Ajustes.
250.................................. Coordination of Benefits
Agreement Claims Selection
Options.
Consolidated Claims Crossover
Process.
Consolidation of the Claims
Crossover Process.
251.................................. Editing Of Hospital And Skilled
Nursing Facility Part B
Inpatient Services.
Inpatient Part B Hospital
Services.
Editing of Hospital Part B
Inpatient Services. Billing for
Inpatient Skilled Nursing
Facility Services Paid Under
Part B.
Editing of Skilled Nursing
Facilities Part B Inpatient
Services.
252.................................. Paper Remittance Advice format
change to accommodate the forced
balancing Amount to balance at
the claim level as well as the
provider level, a flat file
change, and a change in the
companion document for fiscal
intermediaries.
253.................................. Fiscal Intermediary Shared System
Changes to Allow for Provider
Liability Days on Skilled
Nursing Facility and Swing Bed
Facility Inpatient Bills.
Billing Skilled Nursing Facility
Prospective Payment System
Services.
254.................................. October 2004 Outpatient
Prospective Payment System Code
Editor Specifications Version
5.3.
255.................................. October Update to the Medicare
Outpatient Code Editor Version
20.0 for Bills From Hospitals
That Are Not Paid Under the
Outpatient Prospective Payment
System.
256.................................. Use of Group Health Plan Payment
System/Medicare Managed Care
System To Pay Capitated Payments
to Chronic Care Improvement
Organizations Serving Medicare
Fee-For-Service Beneficiaries
Under Section 721 of the
Medicare Modernization Act.
257.................................. Shared Systems Changes for
Medicare Part B Drugs for End
Stage Renal Disease Independent
Dialysis Facilities.
258.................................. New Waived Tests--October 1,
2004.
259.................................. Scheduled Release for October
Updates to Software Programs and
Pricing/Coding Files.
260.................................. Cryosurgery of the Prostate.
Cryosurgery of the Prostate
Gland.
Coverage Requirements.
[[Page 78434]]
Billing Requirements.
Payment Requirements.
261.................................. Billing and Requirements for
Islet Cell Transplantation for
Beneficiaries in a National
Institutes of Health Clinical
Trial.
Billing Requirements for Islet
Cell Transplantation for
Beneficiaries in a National
Institutes of Health Clinical
Trial.
Healthcare Common Procedural
Coding System Codes for
Carriers.
Applicable Modifier for Islet
Cell Transplant Claims for
Carriers.
Special Billing and Payment
Requirements for Carriers.
Special Billing and Payment
Requirements for Intermediaries.
Special Billing and Payment
Requirements Medicare Advantage
Beneficiaries.
262.................................. Confidential.
263.................................. Inpatient Rehabilitation Facility
Annual Update: Prospective
Payment System.
Pricer Changes for Fiscal Year
2005.
Outlier Payments: Cost-to-Charge
Ratios.
264.................................. This Transmittal is Rescinded and
Replaced with Transmittal 271.
265.................................. Issued to a specific audience,
not posted to Internet/Intranet
due to confidentiality of
instruction.
266.................................. Revision of Common Working File
Editing for Same-Day, Same-
Provider Acute Care
Readmissions.
Repeat Admissions.
267.................................. Crossover Patients in New Long
Term Care Hospital.
Billing Procedures for a Provider
Assigned Multiple Provider
Numbers or a Change in Provider
Number.
Crossover Patients in New Long
Term Care Hospital.
268.................................. Medicare Part A Skilled Nursing
Facility Prospective Payment.
System Pricer Update Fiscal Year
2005.
Skilled Nursing Facility
Prospective Payment System
Pricer Software.
269.................................. This Transmittal Replaces
Transmittal 244.
270.................................. This Transmittal Replaces
Transmittal 239.
271.................................. This Transmittal Replaces
Transmittal 264.
272.................................. October Quarterly Update for 2004
Durable Medical Equipment,
Prosthetics, Orthotics, and
Supplies Fee Schedule.
273.................................. Modification of CMS' Medicare
Contingency Plan for Health
Insurance Portability &
Accountability Act
Implementation.
Receipt Date.
Payment Ceiling Standards.
Payment Floor Standards.
Determining and Paying Interest.
274.................................. Good Cause Waiver of Late Claim
Filing Payment Reduction
Penalty.
Extend Time for Good Cause.
Conditions Which Establish Good
Cause.
Procedure to Establish Good
Cause.
Good Cause Is Not Found.
Preparing Common Working File
Claim Records for Services
Subject to 10 Percent Payment
Reduction.
275.................................. The Supplemental Security Income/
Medicare Beneficiary Data for
Fiscal Year 2003 for Inpatient
Prospective Payment System
Hospitals.
276.................................. Further Information Related to CR
3175, Distinct Part Units of
Critical Access Hospitals.
Requirements for Critical Access
Hospital Services, Critical
Access Hospital Skilled Nursing
Care Services and Distinct Part
Units.
Inpatient Rehabilitation Facility
Prospective Payment System.
Billing Requirements Under
Inpatient Rehabilitation
Facility Prospective Payment
System.
277.................................. Sensitive.
278.................................. This Transmittal is no longer
sensitive and can be posted to
Internet/Intranet.
279.................................. Issued to a specific audience,
not posted to Internet/Intranet
due to sensitivity of
instruction.
280.................................. Issued to a specific audience,
not posted to Internet/Intranet
due to sensitivity of
instruction.
281.................................. Issued to a specific audience,
not posted to Internet/Intranet
due to confidentiality of
instruction.
282.................................. This Transmittal replaces
Transmittal 274.
283.................................. 2005 Healthcare Common Procedure
Coding System Annual Update
Reminder.
Health Care Common Procedure
Coding System Annual Update
Reminder.
284.................................. Durable Medical Equipment
Regional Carriers Only--Appeals
of Duplicate Claims.
285.................................. Addition of Physician Assistants,
Nurse Practitioners and Clinical
Nurse.
Specialists as Emergency On-Call
Providers for Critical Access
Hospitals.
Costs of Emergency Room On-Call
Providers.
286.................................. Medicare Physician Fee Schedule
Database 2005 File Layout.
Addendum.
287.................................. Schedule for Completing the
Calendar Year 2005 Fee Schedule
Updates and the Participating
Physician Enrollment Procedures.
288.................................. Fiscal Year 2005 Payment for
Services Furnished in Ambulatory
Surgical Centers.
289.................................. File Descriptions and
Instructions for Retrieving the
2005 Pricing Files Through CMS''
Mainframe Telecommunications
System.
Recurring Update Notification
Containing New Pricing File
Names and Retrieval Dates for
2005.
290.................................. October 2004 Update of the
Hospital Outpatient Prospective
Payment System.
291.................................. Use of Transmission Date in the
Service Date/Assessment Date
Field for Inpatient
Rehabilitation Facility
Prospective Payment System
Claims.
Payment Adjustment for Late
Transmission of Patient
Assessment Data.
292.................................. Confidential.
293.................................. Confidential.
294.................................. Sensitive/Controversial.
[[Page 78435]]
295.................................. Transmittal 214 is Rescinded and
Replaced with Transmittal 295.
296.................................. This Transmittal replaces
Transmittal 196.
297.................................. Reasonable Charge Update for 2005
for Splints, Casts, Dialysis
Supplies, Dialysis Equipment,
Therapeutic Shoes, and Certain
Intraocular Lenses.
298.................................. This Transmittal replaces
Transmittal 295.
299.................................. Use of Condition Code 44,
``Inpatient Admission Changed to
Outpatient''.
300.................................. Payment For Outpatient End Stage
Renal Disease-Related Services.
301.................................. Transmittal 301 Replaces
Transmittal 251.
302.................................. Nursing Facility Visits (Codes
99301-99313).
303.................................. Instructions for Completion of
Form CMS-1450.
304.................................. Transmittal 304 Replaces
Transmittal 205.
--------------------------------------
Medicare Secondary Payer (CMS-Pub. 100-05)
------------------------------------------------------------------------
17................................... Clarification of CR 3064.
General Policy.
18................................... Application of the Medicare
Secondary Payer for the Working
Aged Provision and the Medicare
Secondary for the Disabled
Provision to Former Spouses and
Certain Family Members With
Coverage Under the Federal
Employees Health Benefits
Program.
Individuals Not Subject to the
Limitation on Payment.
Individuals Not Subject to
Medicare Secondary Payer
Provision.
19................................... Clarification of Medicare
Secondary Payer Rules in
Relation to a Temporary Leave of
Absence.
Rules Defining Employees Covered
by Group Health Plans and Large
Group Health Plans.
--------------------------------------
Medicare Financial Management (CMS-Pub. 100-06)
------------------------------------------------------------------------
49................................... Procedures For Re-Issuance and
Stale Dating of Medicare Checks
50................................... Unsolicited/Voluntary Refunds
General Information.
Office of Inspector General
Initiatives.
Unsolicited/Voluntary Refund
Accounts.
Receiving and Processing
Unsolicited/Voluntary Refund
Checks When Identifying
Information Is Provided.
51................................... This transmittal is rescinded and
replaced with Transmittal 52.
52................................... Notice of New Interest Rate for
Medicare Overpayments and
Underpayments.
53................................... Change Request 3367, Debt
Collection System, replaces
Change Request 2952, Debt
Collection System
54................................... Notification to Providers of
Intent to Complete a Post-
Payment Audit.
Contractor's Responsibility Prior
to Submission of Cost Reports.
--------------------------------------
Medicare State Operations Manual (Pub. 100-07)
------------------------------------------------------------------------
02................................... Provider Identification Number.
--------------------------------------
Medicare Program Integrity (CMS-Pub. 100-08)
------------------------------------------------------------------------
79................................... Local Medical Review Policy/Local
Coverage Determination Medicare
Summary.
Notice Message Revision.
Prepayment Edits.
80................................... Program Integrity Management
Fraud and Abuse Complaint
Screening Revisions. Complaint
Screening.
81................................... Implementation of the Quarterly
Strategy Analysis.
The Quarterly Strategy Analysis.
The Quarterly Strategy Analysis
Format.
Executive Summary.
Problem Specific Activities.
Problem Specific Activity
Definitions.
Narrative.
82................................... Home Health Demand Bills.
Home Health.
Effectuating Favorable Final
Appellate.
Decisions That a Beneficiary Is
``Confined to Home'' .
Medical Review of Home Health
Demand Bills.
83................................... Program Integrity Management
Revisions for Chapter 4.
Program Safeguard Contractor and
Medicare Contractor Benefit
Integrity Unit.
Benefit Integrity Security
Requirements.
Medical Review for Benefit
Integrity Purposes.
Requests for Information from
Outside Organizations.
Conducting Investigations.
Disposition of Cases.
Types of Fraud Alerts.
Background.
Investigation, Case, and
Suspension Entries.
Initial Entry Requirements for
Investigations.
Referral of Cases to the Office
of the Inspector General/Office
of Investigations.
[[Page 78436]]
Suspension.
Referral to Quality Improvement
Organizations
Exceptions.
--------------------------------------
Medicare Contractor Beneficiary and Provider Communications (CMS-Pub.
100-09)
------------------------------------------------------------------------
07................................... Confidential.
--------------------------------------
Medicare Managed Care (CMS-Pub. 100-16)
------------------------------------------------------------------------
56................................... Administrative Contracting
Requirements.
57................................... Coverage of Clinical Trials.
Hospital Inpatient Data.
Diagnostic Coding and Guidelines
for Data Collection From
Provider Network.
58................................... Terminology.
59................................... State and County Code
Corrections.
Completion of Enrollment Form.
Passive Elections.
Eligibility Requirements for
Medicare Medical Savings Account
Plans.
Annual Elective Period.
Open Enrollment Period.
Open Enrollment Period Through
2005.
Open Enrollment Period in 2006.
Open Enrollment Period in 2007
and Beyond.
Open Enrollment for Newly
Eligible Individuals in 2006 and
Beyond.
Open Enrollment Period for
Institutionalized Individuals in
2006 and Beyond.
Special Enrollment Period for
Beneficiaries Age 65.
60................................... Streamlined Marketing Review
Process.
File and Use.
Guidelines for Advertising and
Pre-Enrollment Materials.
Guidelines for Advertising
Materials.
Guidelines for Pre-Enrollment
Materials.
61................................... Emergency and Urgently Needed
Services.
62................................... Revisions to Chapter 13--
Medicare+Choice Beneficiary
Grievances, Organization
Determinations and Appeals.
--------------------------------------
Demonstrations (CMS-Pub. 100-19)
------------------------------------------------------------------------
05................................... Use of Group Health Plan Payment
System to Pay Capitated Payments
to Non-Health Plan Demonstration/
Program Sites Serving Medicare
Fee For Service Beneficiaries--
Updated List of Plan Numbers.
06................................... Revision of CR 3269 for the
Demonstration Project to Clarify
the Definition of Homebound
(Homebound Demonstration).
--------------------------------------
One Time Notification (CMS-Pub. 100-20)
------------------------------------------------------------------------
92................................... Additional Instructions Related
to the ``Redistribution of
Unused Resident Positions,''
Section 422 of the Medicare
Modernization Act of 2003 P.L.
108-173, for Purposes of
Graduate Medical Education
Payments.
93................................... Temporary Skilled Nursing
Facility Extension.
94................................... Shared System Maintainer Hours
for Resolution of Problems
Detected During Health Insurance
Portability and Accountability
Act.
Transaction Release Testing.
95................................... Modifications to Post-payment
Adjustment Process for Home
Health Prospective Payment
System Claims Failing to Report
Prior Inpatient Discharges.
96................................... Annual Changes to the Amount in
Controversy Thresholds For the
Administrative Law Judge and
Judicial Review.
Levels of the Claim Appeals
Process as Required by Section
940 of the Medicare Prescription
Drug, Improvement, and
Modernization Act of 2003.
97................................... Implementation of the Business
Segment Identifier in the
Healthcare Integrated General
Ledger Accounting System.
98................................... Change to Previous Transmittal
Regarding the Discounted Use of
Revenue Code 0910.
99................................... This One-Time Notification is a
full replacement for Transmittal
86.
100.................................. This Transmittal is Rescinded and
Replaced with Transmittal 103.
101.................................. Change of the Premera Blue Cross
Medicare Part A Plan Under
Contract to BCBSA to a Part A
Fiscal Intermediary Contract
with Noridian Mutual Insurance
Company in the States of
Washington and Alaska.
102.................................. Update to the Healthcare Provider
Taxonomy Codes/Medicare
Specialty Code Crosswalk.
103.................................. This Transmittal replaces
Transmittal 100.
104.................................. Confidential.
105.................................. Confidential.
106.................................. Medicare Modernization Act Drug
Pricing Update-Payment Limits
for J9045 (Carboplatin
Injection) and (Rituximab Cancer
Treatment).
107.................................. Common Working File Analysis to
Process Claims Per the Renovated
Override Code Processing (re:
CR3190) and Common Working File
Analysis to Review System Edits
for Additional 2-byte Modifiers
Added in CR3190 (Phase 2).
108.................................. New Remark Code Message for Use
With Claims for Parental Pumps-
Durable Medical Equipment
Regional Carrier Only.
109.................................. Billing Instructions for ADVATE
rAHF-PFM on Medicare Claims.
110.................................. Medicare Modernization Act Drug
Pricing Update-Payment Limits
for J100 (Depo-estradiol
cypionate inj).
111.................................. Creation of Common Working File
Auxilliary File and Associated
Logic to Property.
[[Page 78437]]
Calculate Medicare-Equivalent
Deductibles for Department of
Veteran Affairs Claims.
112.................................. This Transmittal replaces
Transmittal 109.
113.................................. Implementation of Sec. 921 of
the Medicare Modernization Act
Provider Customer Program.
114.................................. Sensitive.
115.................................. Instructions for Fiscal
Intermediary Standard System and
Multi-Carrier System Healthcare
Integrated General Ledger
Accounting System Changes.
116.................................. Notification of Medlearn Matters
Article for Confidential Change
Request (CR) 3301.
------------------------------------------------------------------------
Addendum IV.--Regulation Documents Published in the Federal Register
[July 2004 Through September 2004]
--------------------------------------------------------------------------------------------------------------------------------------------------------
FR Vol. 69
Publication date page No. CFR parts affected File code Title of regulation
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 1, 2004........................ 40288 42 CFR Part 414............................ CMS-1492-IFC Medicare Program; Medicare
Ambulance MMA Temporary Rate
Increases Beginning July 1,
2004.
July 23, 2004....................... 44036 ........................................... CMS-1334-N Medicare Program; Public
Meeting in Calendar Year
2004 for Coding and Payment
Determinations for Power
Wheelchairs.
July 23, 2004....................... 44035 ........................................... CMS-1364-N Medicare Program; August 30,
2004, Meeting of the
Practicing Physicians
Advisory Council and Request
for Nominations.
July 23, 2004....................... 44034 ........................................... CMS-4074-N Medicare Program; Meeting of
the Advisory Panel on
Medicare Education--
September 9, 2004.
July 23, 2004....................... 44031 ........................................... CMS-3142-NC Medicare Program; Evaluation
Criteria and Standards for
Quality Improvement Program
Contracts.
July 23, 2004....................... 44029 ........................................... CMS-3112-NC2 Medicare Program; Adjustment
in Payment Amounts for New
Technology Intraocular
Lenses Furnished by
Ambulatory Surgical Centers.
July 23, 2004....................... 44027 ........................................... CMS-2202-PN Medicare and Medicaid
Programs; Application by the
American Association for
Accreditation of Ambulatory
Surgery Facilities, Inc.,
for Continued Deeming
Authority for Ambulatory
Surgical Centers.
July 23, 2004....................... 44013 ........................................... CMS-2187-N State Children's Health
Insurance Program (SCHIP);
Extended Availability of
Unexpended SCHIP Funds From
the Appropriation for Fiscal
Years 1998 Through 2001; and
Provision of Authority for
Qualifying States To Use a
Portion of SCHIP Funds for
Medicaid Expenditures.
July 23, 2004....................... 43956 42 CFR Part 402............................ CMS-6146-P Medicare Program; Revised
Civil Money Penalties,
Assessments, Exclusions, and
Related Appeals Procedures.
July 23, 2004....................... 43926 45 CFR Part 146............................ CMS-2033-F Requirements for the Group
Health Insurance Market; Non-
Federal Governmental Plans
Exempt From HIPAA Title I
Requirements.
July 23, 2004....................... 43924 45 CFR Part 146............................ CMS-2152-F2 Amendment to the Interim
Final Regulation for Mental
Health Parity.
July 30, 2004....................... 45822 ........................................... CMS-4068-N Medicare Program; Open Public
Meeting Regarding the
Development of the Model
Guidelines for Categories
and Classes of Drugs.
July 30, 2004....................... 45775 ........................................... CMS-1249-N Medicare Program; Prospective
Payment System and
Consolidated Billing for
Skilled Nursing Facilities--
Update.
July 30, 2004....................... 45721 ........................................... CMS-1360-N Medicare Program; Inpatient
Rehabilitation Facility
Prospective Payment System
for Fiscal Year 2005.
July 30, 2004....................... 45640 42 CFR Part 484............................ CMS-1265-CN Medicare Program; Home Health
Prospective Payment System
Rate Update for Calendar
Year 2005; Correction
Notice.
July 30, 2004....................... 45604 42 CFR Parts 405 and 411................... CMS-6014-F Medicare Program; Interest
Calculation.
August 3, 2004...................... 46866 42 CFR Parts 417 and 422................... CMS-4069-P Medicare Program;
Establishment of the
Medicare Advantage Program.
August 3, 2004...................... 46632 42 CFR Parts 403, 411, 417, and 423........ CMS-4068-P Medicare Program; Medicare
Prescription Drug Benefit.
August 5, 2004...................... 47488 42 CFR Parts 405, 410, 411, 414, 418, 424, CMS-1429-P Medicare Program; Revisions
484, and 486. to Payment Policies Under
the Physician Fee Schedule
for Calendar Year 2005.
August 5, 2004...................... 47446 ........................................... CMS-1275-N Medicare Program; Meeting of
the Advisory Panel on
Ambulatory Payment
Classification Groups--
September 1, 2, and 3, 2004.
[[Page 78438]]
August 11, 2004..................... 48916 42 CFR Parts 403, 412, 413, 418, 460, 480, CMS-1428-F Medicare Program; Changes to
482, 483, 485, and 489. the Hospital Inpatient
Prospective Payment Systems
and Fiscal Year 2005 Rates.
August 16, 2004..................... 50448 42 CFR Parts 410, 411, 419................. CMS-1427-P Medicare Program; Proposed
Changes to the Hospital
Outpatient and Prospective
Payment System and Calendar
Year 2005 Payment Rates.
August 27, 2004..................... 52723 ........................................... CMS-1279-N2 Medicare Program; Public
Meeting of the Program
Advisory and Oversight
Committee (PAOC) for Quality
Standards and Competitive
Acquisition of Certain
Durable Medical Equipment,
Prosthetics, Orthotics, and
Supplies (DMEPOS).
August 27, 2004..................... 52722 ........................................... CMS-3136-N Medicare Program; Meeting of
the Medicare Coverage
Advisory Committee--
September 28, 2004.
August 27, 2004..................... 52721 ........................................... CMS-5025-CN Medicare Program; Medicare
Replacement Drug
Demonstration; Correction.
August 27, 2004..................... 52710 ........................................... CMS-1264-N Medicare Program; Hospice
Wage Index for Fiscal Year
2005.
August 27, 2004..................... 52706 ........................................... CMS-4067-PN Medicare and Medicaid
Programs; Application by the
Utilization Review
Accreditation Commission
(URAC) for Deeming Authority
for Medicare Advantage.
August 27, 2004..................... 52700 ........................................... CMS-2201-N State Children's Health
Insurance Program; Final
Allotments to States, the
District of Columbia, and
U.S. Territories and
Commonwealths for Fiscal
Year 2005.
August 27, 2004..................... 52699 ........................................... CMS-1269-N2 Medicare Program; Second
Request for Nominations for
Two Specific Categories of
Members of the Emergency
Medical Treatment and Labor
Act (EMTALA) Technical
Advisory Group (TAG).
August 27, 2004..................... 52620 42 CFR Parts 431 and 457................... CMS-6026-P Medicaid Program and State
Children's Health Insurance
Program (SCHIP): Payment
Error Rate Measurement.
August 27, 2004..................... 52620 42 CFR Part 402............................ CMS-6146-CN Medicare Program; Revised
Civil Money Penalties,
Assessments, Exclusions, and
Related Appeals Procedures.
September 9, 2004................... 54674 ........................................... CMS-8020-N Medicare Program; Medicare
Part B Monthly Actuarial
Rates, Premium Rate, and
Annual Deductible Beginning
January 1, 2005.
September 9, 2004................... 54673 ........................................... CMS-8022-N Medicare Program; Part A
Premium for 2005 for the
Uninsured Aged and for
Certain Disabled Individuals
Who Have Exhausted Other
Entitlement, Thursday,
September 9, 2004.
September 9, 2004................... 54671 ........................................... CMS-8021-N Medicare Program; Inpatient
Hospital Deductible and
Hospital and Extended Care
Services Coinsurance Amounts
for 2005, Thursday,
September 9, 2004.
September 14, 2004.................. 55440 ........................................... CMS-6027-N Medicare Program; September
30, 2004 Open Door Forum:
Requirements for
Coordination Between Plans
Primary or Secondary to
Medicare Part D Under the
Medicare Prescription Drug,
Improvement, and
Modernization Act of 2003
(MMA).
September 16, 2004.................. 55763 42 CFR Part 414............................ CMS-1380-F Medicare Program;
Manufacturer Submission of
Manufacturer's Average Sales
Price (ASP) Data for
Medicare Part B Drugs and
Biologicals.
September 24, 2004.................. 57325 ........................................... CMS-3141-N Procedure for Producing
Guidance Documents
Describing Medicare's
Coverage Process.
September 24, 2004.................. 57325 ........................................... CMS-3137-N Medicare Program; Meeting of
the Medicare Coverage
Advisory Committee--November
4, 2004.
September 24, 2004.................. 57324 ........................................... CMS-2200-N4 Medicare Program; Meeting of
the State Pharmaceutical
Assistance Transition
Commission--October 14,
2004.
September 24, 2004.................. 57312 ........................................... CMS-9023-N Medicare and Medicaid
Programs; Quarterly Listing
of Program Issuances--April
2004 Through June 2004.
September 24, 2004.................. 57310 ........................................... CMS-4077-PN Medicare and Medicaid
Programs; Application by the
National Committee for
Quality Assurance Preferred
Provider Organization for
Deeming Authority for
Medicare Advantage.
September 24, 2004.................. 57308 ........................................... CMS-2208-PN Medicare and Medicaid
Programs; Application by the
American Osteopathic
Association for Continued
Approval of Deeming
Authority for Hospitals.
September 24, 2004.................. 57307 ........................................... CMS-2256-PN Medicare and Medicaid
Programs; Application by the
Community Health
Accreditation Program (CHAP)
for Home Health Agencies.
[[Page 78439]]
September 24, 2004.................. 57305 ........................................... CMS-2204-PN Medicare and Medicaid
Programs; Application by the
Joint Commission on
Accreditation of Healthcare
Organizations (JCAHO) for
Home Health Agencies.
September 24, 2004.................. 57304 ........................................... CMS-3154-N Medicare Program; Request for
Nominations for Members for
the Medicare Coverage
Advisory Committee.
September 24, 2004.................. 57244 42 CFR Parts 431 and 457................... CMS-6026-CN Medicaid Program and State
Children's Health Insurance
Program (SCHIP); Payment
Error Rate Measurement;
Correction.
September 24, 2004.................. 57226 42 CFR Part 411............................ CMS-1810-IFC2 Medicare Program; Physicians'
Referrals to Health Care
Entities With Which They
Have Financial Relationships
(Phase II); Correcting
Amendment.
September 24, 2004.................. 57224 42 CFR Part 406............................ CMS-4018-F Medicare Program;
Continuation of Medicare
Entitlement When Disability
Benefit Entitlement Ends
Because of Substantial
Gainful Activity.
September 24, 2004.................. 57859 42 CFR Part 493............................ ......................... Laboratory Requirements; OFR
Correction.
September 30, 2004.................. 58596 42 CFR Parts 431 and 457................... CMS-6026-CN Medicaid Program and State
Children's Health Insurance
Program (SCHIP); Payment
Error Rate Measurement; OFR
Correction.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Addendum V--National Coverage Determinations [July 2004 Through
September 2004]
A national coverage determination (NCD) is a determination by the
Secretary with respect to whether or not a particular item or service
is covered nationally under Title XVIII of the Social Security Act, but
does not include a determination of what code, if any, is assigned to a
particular item or service covered under this title, or determination
with respect to the amount of payment made for a particular item or
service so covered. We include below all of the NCDs that were issued
during the quarter covered by this notice. The entries below include
information concerning completed decisions as well as sections on
program and decision memoranda, which also announce pending decisions
or, in some cases, explain why it was not appropriate to issue an NCD.
We identify completed decisions 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. Information on completed decisions
as well as pending decisions has also been posted on the CMS website at
http://cms.hhs.gov/coverage.
National Coverage Determinations
[July 2004 Through September 2004]
----------------------------------------------------------------------------------------------------------------
Title NCDM section TN Issue date Effective date
----------------------------------------------------------------------------------------------------------------
Manualization of Negotiated Clinical N/A................. R17NCD.............. 07/02/2004 07/02/2004
Diagnostic Laboratory NCDs.
Changes to the Laboratory NCD Edit N/A................. R225CP.............. 04/09/2004 10/04/2004
Software for October 2004.
Blood-Derived Products for Chronic 270.3............... R19NCD.............. 07/30/2004 07/23/2004
Non-Healing Wounds.
Islet Cell Transplantation.......... 260.3.1............. R18NCD.............. 07/30/2004 10/04/2004
MRS for Diagnosing Brain Tumors..... 220.2.1............. R21NCD.............. 09/10/2004 09/10/2004
----------------------------------------------------------------------------------------------------------------
Addendum VI--FDA-Approved Category B IDEs
Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices
fall into one of three classes. To assist CMS under this categorization
process, the FDA assigns one of two categories to each FDA-approved
IDE. Category A refers to experimental IDEs, and Category B refers to
non-experimental IDEs. To obtain more information about the classes or
categories, please refer to the Federal Register notice published on
April 21, 1997 (62 FR 19328).
The following list includes all Category B IDEs approved by FDA
during the 2nd quarter, July 2004 Through September 2004.
IDE Category
G030093
G030237
G040049
G040052
G040057
G040091
G040092
G040094
G040096
G040098
G040099
G040100
G040102
G040103
G040104
G040105
G040109
G040111
G040112
G040113
G040119
G040122
G040124
G040126
G040128
G040129
G040130
G040134
G040137
G040142
G040143
G040144
G040145
G040146
G040147
G040148
G040149
G040150
[[Page 78440]]
G040153
G040154
G040160
G980099
Addendum VII-Approval Numbers for Collections of Information
Below we list all approval numbers for collections of information
in the referenced sections of CMS regulations in Title 42; Title 45,
Subchapter C; and Title 20 of the Code of Federal Regulations, which
have been approved by the Office of Management and Budget:
------------------------------------------------------------------------
Approved CFR Sections in Title 42,
Title 45, and Title 20 (Note:
OMB control numbers Sections in Title 45 are preceded by
``45 CFR,'' and sections in Title 20
are preceded by ``20 CFR'')
------------------------------------------------------------------------
0938-0008........................ 414.40, 424.32, 424.44
0938-0022........................ 413.20, 413.24, 413.106
0938-0023........................ 424.103
0938-0025........................ 406.28, 407.27
0938-0027........................ 486.100-486.110
0938-0033........................ 405.807
0938-0035........................ 407.40
0938-0037........................ 413.20, 413.24
0938-0041........................ 408.6, 408.22
0938-0042........................ 410.40, 424.124
0938-0045........................ 405.711
0938-0046........................ 405.2133
0938-0050........................ 413.20, 413.24
0938-0062........................ 431.151, 435.1009, 440.220, 440.250,
442.1, 442.10-442.16, 442.30,
442.40, 442.42, 442.100-442.119,
483.400-483.480, 488.332, 488.400,
498.3-498.5
0938-0065........................ 485.701-485.729
0938-0074........................ 491.1-491.11
0938-0080........................ 406.7, 406.13
0938-0086........................ 420.200-420.206, 455.100-455.106
0938-0101........................ 430.30
0938-0102........................ 413.20, 413.24
0938-0107........................ 413.20, 413.24
0938-0146........................ 431.800-431.865
0938-0147........................ 431.800-431.865
0938-0151........................ 493.1405, 493.1411, 493.1417,
493.1423, 493.1443, 493.1449,
493.1455, 493.1461, 493.1469,
493.1483, 493.1489
0938-0155........................ 405.2470
0938-0170........................ 493.1269-493.1285
0938-0193........................ 430.10-430.20, 440.167
0938-0202........................ 413.17, 413.20
0938-0214........................ 411.25, 489.2, 489.20
0938-0236........................ 413.20, 413.24
0938-0242........................ 488.26, 442.30
0938-0245........................ 407.10, 407.11
0938-0246........................ 431.800-431.865
0938-0251........................ 406.7
0938-0266........................ 416.41, 416.47, 416.48, 416.83
0938-0267........................ 410.65, 485.56, 485.58, 485.60,
485.64, 485.66
0938-0269........................ 412.116, 412.632, 413.64, 413.350,
484.245
0938-0270........................ 405.376
0938-0272........................ 440.180, 441.300-441.305
0938-0273........................ 485.701-485.729
0938-0279........................ 424.5
0938-0287........................ 447.31
0938-0296........................ 413.170, 413.184
0938-0301........................ 413.20, 413.24
0938-0302........................ 418.22, 418.24, 418.28, 418.56,
418.58, 418.70, 418.74, 418.83,
418.96, 418.100
0938-0313........................ 489.11, 489.20
0938-0328........................ 482.12, 482.13, 482.21, 482.22,
482.27, 482.30, 482.41, 482.43,
482.45, 482.53, 482.56, 482.57,
482.60, 482.61, 482.62, 482.66,
485.618, 485.631
0938-0334........................ 491.9, 491.10
0938-0338........................ 486.104, 486.106, 486.110
0938-0354........................ 441.60
0938-0355........................ 488.26, 442.30
0938-0358........................ 412.20-412.30
0938-0359........................ 412.40-412.52
0938-0360........................ 488.60
0938-0365........................ 484.10, 484.11, 484.12, 484.14,
484.16, 484.18, 484.20, 484.36,
484.48, 484.52
0938-0372........................ 414.330
0938-0378........................ 482.60-482.62
0938-0379........................ 488.26, 442.30
0938-0382........................ 488.26, 442.30
0938-0386........................ 405.2100-405.2171
0938-0391........................ 488.18, 488.26, 488.28
0938-0426........................ 476.104, 476.105, 476.116, 476.134
0938-0429........................ 447.53
0938-0443........................ 473.18, 473.34, 473.36, 473.42
[[Page 78441]]
0938-0444........................ 1004.40, 1004.50, 1004.60, 1004.70
0938-0445........................ 412.44, 412.46, 431.630, 456.654,
466.71, 466.73, 466.74, 466.78
0938-0447........................ 405.2133
0938-0448........................ 405.2133, 45 CFR 5, 5b; 20 CFR Parts
401, 422E
0938-0449........................ 440.180, 441.300-441.310
0938-0454........................ 424.20
0938-0456........................ 412.105
0938-0463........................ 413.20, 413.24, 413.106
0938-0467........................ 431.17, 431.306, 435.910, 435.920,
435.940-435.960
0938-0469........................ 417.126, 422.502, 422.516
0938-0470........................ 417.143, 417.800-417.840, 422.6
0938-0477........................ 412.92
0938-0484........................ 424.123
0938-0501........................ 406.15
0938-0502........................ 433.138
0938-0512........................ 486.304, 486.306, 486.307
0938-0526........................ 475.102, 475.103, 475.104, 475.105,
475.106
0938-0534........................ 410.38, 424.5
0938-0544........................ 493.1-493.2001
0938-0564........................ 411.32
0938-0565........................ 411.20-411.206
0938-0566........................ 411.404, 411.406, 411.408
0938-0573........................ 412.230, 412.256
0938-0578........................ 447.534
0938-0581........................ 493.1-493.2001
0938-0599........................ 493.1-493.2001
0938-0600........................ 405.371, 405.378, 413.20
0938-0610........................ 417.436, 417.801, 422.128, 430.12,
431.20, 431.107, 434.28, 483.10,
484.10, 489.102
0938-0612........................ 493.801, 493.803, 493.1232, 493.1233,
493.1234, 493.1235, 493.1236,
493.1239, 493.1241, 493.1242,
493.1249, 493.1251, 493.1252,
493.1253, 493.1254, 493.1255,
493.1256, 493.1261, 493.1262,
493.1263, 493.1269, 493.1273,
493.1274, 493.1278, 493.1283,
493.1289, 493.1291, 493.1299
0938-0618........................ 433.68, 433.74, 447.272
0938-0653........................ 493.1771, 493.1773, 493.1777
0938-0657........................ 405.2110, 405.2112
0938-0658........................ 405.2110, 405.2112
0938-0667........................ 482.12, 488.18, 489.20, 489.24
0938-0679........................ 410.38
0938-0685........................ 410.32, 410.71, 413.17, 424.57,
424.73, 424.80, 440.30, 484.12
0938-0686........................ 493.551-493.557
0938-0688........................ 486.304, 486.306, 486.307, 486.310,
486.316, 486.318, 486.325
0938-0690........................ 488.4-488.9, 488.201
0938-0691........................ 412.106
0938-0692........................ 466.78, 489.20, 489.27
0938-0701........................ 422.152
0938-0702........................ 45 CFR 146.111, 146.115, 146.117,
146.150, 146.152, 146.160, 146.180
0938-0703........................ 45 CFR 148.120, 148.124, 148.126,
148.128
0938-0714........................ 411.370-411.389
0938-0717........................ 424.57
0938-0721........................ 410.33
0938-0723........................ 421.300-421.318
0938-0730........................ 405.410, 405.430, 405.435, 405.440,
405.445, 405.455, 410.61, 415.110,
424.24
0938-0732........................ 417.126, 417.470
0938-0734........................ 45 CFR 5b
0938-0739........................ 413.337, 413.343, 424.32, 483.20
0938-0742........................ 422.300-422.312
0938-0749........................ 424.57
0938-0753........................ 422.000-422.700
0938-0754........................ 441.152
0938-0758........................ 413.20, 413.24
0938-0760........................ 484 Subpart E, 484.55
0938-0761........................ 484.11, 484.20
0938-0763........................ 422.1-422.10, 422.50-422.80, 422.100-
422.132, 422.300-422.312, 422.400-
422.404, 422.560-422.622
0938-0770........................ 410.2
0938-0778........................ 422.111, 422.64
0938-0779........................ 417.470, 417.126, 422.210, 422.64
0938-0781........................ 411.404-411.406, 484.10
0938-0786........................ 438.352, 438.360, 438.362, 438.364
0938-0787........................ 406.28, 407.27
0938-0790........................ 460.12, 460.22, 460.26, 460.30,
460.32, 460.52, 460.60, 460.70,
460.71, 460.72, 460.74, 460.80,
460.82, 460.98, 460.100, 460.102,
460.104, 460.106, 460.110, 460.112,
460.116, 460.118, 460.120, 460.122,
460.124, 460.132, 460.152, 460.154,
460.156, 460.160, 460.164, 460.168,
460.172, 460.190, 460.196, 460.200,
460.202, 460.204, 460.208, 460.210
0938-0792........................ 491.8, 491.11
0938-0798........................ 413.24, 413.65, 419.42
[[Page 78442]]
0938-0802........................ 419.43
0938-0818........................ 410.141, 410.142, 410.143, 410.144,
410.145, 410.146, 414.63
0938-0829........................ 422.568
0938-0832........................ 489 and 491
0938-0833........................ 483.350-483.376
0938-0841........................ 431.636, 457.50, 457.60, 457.70,
457.340, 457.350, 457.431, 457.440,
457.525, 457.560, 457.570, 457.740,
457.750, 457.810, 457.940, 457.945,
457.965, 457.985, 457.1005,
457.1015, 457.1180
0938-0842........................ 412.23, 412.604, 412.606, 412.608,
412.610, 412.614, 412.618, 412.626,
413.64
0938-0846........................ 411.352-411.361
0938-0857........................ 419
0938-0860........................ 419
0938-0866........................ 45 CFR Part 162
0938-0872........................ 413.337, 483.20
0938-0873........................ 422.152
0938-0874........................ 45 CFR Parts 160 and 162
0938-0878........................ 422 Subpart F & G
0938-0883........................ 45 CFR Parts 160 and 164
0938-0884........................ 405.940
0938-0887........................ 45 CFR 148.316, 148.318, 148.320
0938-0897........................ 412.22, 412.533
0938-0907........................ 412.230, 412.304, 413.65
0938-0910........................ 422.624, 422.626, 422.620
0938-0911........................ 426.400, 426.500
0938-0916........................ 483.16
0938-0920........................ 438.6, 438.8, 438.10, 438.12, 438.50,
438.56, 438.102, 438.114, 438.202,
438.206, 438.207, 438.240, 438.242,
438.402, 438.404, 438.406, 438.408,
438.410, 438.414, 438.416, 438.710,
438.722, 438.724, 438.810
0938-0921........................ 414.804
------------------------------------------------------------------------
[FR Doc. 04-28156 Filed 12-29-04; 8:45 am]
BILLING CODE 4120-01-P