[Federal Register: September 26, 2003 (Volume 68, Number 187)]
[Notices]
[Page 55618-55634]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se03-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9018-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--April 2003 Through June 2003
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice lists CMS manual instructions, substantive and
interpretive regulations, and other Federal Register notices that were
published from April 2003 through June 2003, relating to the Medicare
and Medicaid programs. This notice provides information on national
coverage determinations affecting specific medical and health care
[[Page 55619]]
services under Medicare. Additionally, this notice identifies certain
devices with investigational device exemption numbers approved by the
Food and Drug Administration 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 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
Karen Bowman, Office of Strategic Operations and Regulatory Affairs,
Centers for Medicare & Medicaid Services, C5-16-03, 7500 Security
Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-5252.
Questions concerning national coverage determinations 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 Investigational Device Exemptions items in
Addendum VI may be addressed to Sharon Hippler, Office of Clinical
Standards and Quality, Centers for Medicare & Medicaid Services, C5-13-
27, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call
(410) 786-4633.
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
Margie Teeters, Office of Strategic Operations and Regulatory Affairs,
Regulations Development and Issuances 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, national coverage determinations (NCDs), and Food and Drug
Administration (FDA)-approved investigational device exemptions (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 Coverage Issues Manual (CIM) may wish to
review the August 21, 1989 publication (54 FR 34555). Those interested
in the procedures used in making NCDs under the Medicare program may
review the April 27, 1999 publication (64 FR 22619).
To aid the reader, we have organized and divided this current
listing into six addenda:
[sbull] Addendum I lists the publication dates of the most recent
quarterly listings of program issuances.
[sbull] Addendum II identifies previous Federal Register documents
that contain a description of all previously published CMS Medicare and
Medicaid manuals and memoranda.
[sbull] 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.
[sbull] 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--
[sbull] Date published;
[sbull] Federal Register citation;
[sbull] Parts of the Code of Federal Regulations (CFR) that have
changed (if applicable);
[sbull] Agency file code number; and
[sbull] Title of the regulation.
[sbull] 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 CIM in which the
decision appears, the title, the date the publication was issued, and
the effective date of the decision.
[sbull] 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
[[Page 55620]]
numbers are assigned (that is, Category A or Category B), and
identified by the IDE number.
[sbull] 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) 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's 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:
[sbull] Titles XI, XVIII, and XIX of the Act.
[sbull] CMS-related regulations.
[sbull] CMS manuals and monthly revisions.
[sbull] 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.
Superintendent of Documents numbers for each CMS publication are
shown in Addendum III, along with the CMS publication and transmittal
numbers. To help FDLs locate the materials, use the Superintendent of
Documents number, plus the transmittal number. For example, to find the
Carriers Manual, Part 3--Program Administration (CMS Pub. 14-3)
transmittal entitled ``Incident to Physician's Professional Services
(Subsection A--Commonly Furnished in Physicians' Offices),'' use the
Superintendent of Documents No. HE 22.8/7 and the transmittal number
1793.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714,
Medical Assistance Program)
Dated: September 8, 2003.
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.
May 11, 1999 (64 FR 25351)
November 2, 1999 (64 FR 59185)
December 7, 1999 (64 FR 68357)
January 10, 2000 (65 FR 1400)
May 30, 2000 (65 FR 34481)
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)
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 Medicare
Coverage Issues Manual (CIM) 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 55621]]
Addendum III.--Medicare and Medicaid Manual Instructions
[April 2003 Through June 2003]
------------------------------------------------------------------------
Transmittal No. Manual/Subject/Publication No.
------------------------------------------------------------------------
Intermediary Manual
Part 3--Audits, Reimbursement Program Administration
(CMS Pub. 13-3)
(Superintendent of Documents No. HE 22.8/6)
------------------------------------------------------------------------
1879 [sbull Clinical Diagnostic Laboratory Services
] Other Than To Inpatients Screening Pap
Smears and Pelvic Examinations
1880 [sbull Autologous Stem Cell Transplantation
]
1881 [sbull Review of Form HCFA-1450 for Inpatient and
] Outpatient Bills
1882 [sbull Frequency of Billing
]
1883 [sbull Magnetic Resonance Angiography
]
1884 [sbull Telehealth Services
]
1885 [sbull Medicare Payment for Telehealth Services
]
1886 [sbull Payment Without Common Working File
] Approval
1887 [sbull Filing a Request for Payment
]
...... Request for Payment
...... Filing Claims for Payment
...... Time Limits for Requests and Claims for
Payment for Services Reimbursed
...... Effects on Beneficiary and Provider of
Beneficiary's Refusal to File a Request
for Payment
...... Filing Claims Where Usual Time Limit Has
Expired
...... Claims for Payment for Emergency Hospital
Services and Services Outside the United
States
...... Appeals
...... Time Limits for Filing Part B Reasonable
Charge Claims
...... Claims Processing Timeliness
...... Time Limitations for Filing Provider Claims
...... Incomplete or Invalid Claims
...... Addendum L Paper and Electronic Data
Element Requirements
...... Bill Type Codes and Allowable Provider
Numbers
1888 [sbull Screening Pap Smears and Screening Pelvic
] Examinations
1889 [sbull Billing of the Diagnosis and Treatment of
] Peripheral Neuropathy With Loss of
Protective Sensation in People With
Diabetes
1890 [sbull Coverage and Billing of Sacral Nerve
] Stimulation
...... Deep Brain Stimulation for Essential Tremor
and Parkinson's Disease
1891 [sbull International Classification of Diseases
] 9th Edition
...... Clinical Modification Coding for Diagnostic
Tests
--------------------
Carriers Manual
Part 3--Program Administration
(CMS Pub. 14-3)
(Superintendent of Documents No. HE 22.8/7)
------------------------------------------------------------------------
1793 [sbull Incident to Physician's Professional
] Services (Subsection A--Commonly Furnished
in Physicians' Offices)
1794 [sbull The ``Do Not Forward'' Initiative
] (Subsection C--Internal Revenue Services--
1099 Reporting)
1795 [sbull Magnetic Resonance Angiography Coverage
] Summary Coding Requirements
1796 [sbull Skilled Nursing Facility Consolidated
] Billing
...... Determining the End of a Skilled Nursing
Facility Stay
...... Types of Facilities Included in and
Excluded From Consolidated Billing
...... Types of Services Included in and Excluded
From Consolidated Billing
...... Risk-Based Health Maintenance Organization
Beneficiaries
...... Clarification of Ambulance Services
...... Information on a Skilled Nursing Facility
Contracting With Outside Entities for
Services
...... Carrier Claims Processing
...... Special Requirements for Claims for Durable
Medical Equipment, Prosthetics, Orthotics,
and Supplies
...... Revisions to Common Working File Edits To
Permit Payment for Certain Diagnostic
Services Furnished To Beneficiaries
Receiving Treatment for End-Stage Renal
Disease at an Independent or Provider-
Based Dialysis Facility
1797 [sbull Telehealth Claims
]
1798 [sbull Medicare Payment for Telehealth Services
]
1799 [sbull Payment Limit for Certain Drugs and
] Biologicals
...... Procedures for Determining Payment Limit
...... Injection Services
...... Mandatory Assignment for Drugs and
Biologicals
1800 [sbull Drugs and Biologicals
]
...... Definition of Drug or Biological
...... Determining Self-Administration of Drugs or
Biologicals Incident-To Requirements
1801 [sbull Healthcare Common Procedure Coding System
] Coding
...... Common Working File Edits for Flu and
Pneumonia Claims
...... Administrative Bulletin Crossover Edit
...... Payment Requirements
...... No Legal Obligation To Pay
...... Roster Billing
...... Health Maintenance Organization Processing
[[Page 55622]]
...... Specialty Code/Place of Service Processing
1802 [sbull Foot Care and Supportive Devices for Feet
] Foot Care
...... Peripheral Neuropathy With Loss of
Protective Sensation in People With
Diabetes
...... Coverage
...... Applicable Codes
...... Payment Requirements
...... Standard System Edits
...... Common Working File Edits
1803 [sbull End-Stage Renal Disease Bill Procedures
] 1804
1804 [sbull Durable Medical Equipment Regional
] Carriers--Pre-Discharge Delivery of
Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies for Fitting and
Training
1805 [sbull Necessity for Treatment
]
1806 [sbull Intestinal and Multi-Visceral
] Transplantation
...... Approved Transplant Facilities
...... Payment Procedures for Intestinal and Multi-
Visceral Transplants
1807 [sbull International Classification of Diseases
] 9th Edition Clinical Modification
...... Coding for Diagnostic Tests
--------------------
Program Memorandum Intermediaries
(CMS Pub. 60A)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
A-03-020 [sbull April 2003 Update of the Hospital
] Outpatient Prospective Payment System
A-03-021 [sbull Announcement of Medicare Rural Health
] Clinics and Federally Qualified
...... Health Centers Payment Rate Increases,
Clarification on Coverage and Payment of
Diabetes Self-Management Training Services
and Medical Nutrition Therapy Services
A-03-022 [sbull Installation of Version 29.0 of the
] Provider Statistical and Reimbursement
Reporting System--Modification A-03-023
A-03-023 [sbull Implementation of the Temporary
] Equalization of Urban and Rural
Standardized Payment Amounts Under the
Medicare Inpatient Hospital Prospective
Payment System as Required By Section
402(b) of Public Law 108-7
A-03-024 [sbull Advance Beneficiary Notices Must Be Given
] To Beneficiaries and Demands Bills Must Be
Submitted By Home Health Agencies
A-03-025 [sbull Advance Beneficiary Notices Must Be Given
] To Beneficiaries and Demands Bills Must Be
Submitted By Home Health Agencies
A-03-026 [sbull April Outpatient Code Editor Specifications
] Version (V4.1)
A-03-027 [sbull Updated Outpatient Prospective Payment
] System: Requirements for Provider
Education and Training
A-03-028 [sbull January Medicare Outpatient Code Editor
] Specifications Version 18.1R1 for Bills
From Hospitals That Are Not Paid Under the
Outpatient Prospective Payment System
A-03-029 [sbull Corrections to: Changes to the Hospital
] Inpatient Prospective Payment Systems and
Rates and Costs of Graduate Medical
Education, etc., as Published in the
Federal Register, Fiscal Year 2003 (67 FR
49982, August 1, 2002)
A-03-030 [sbull Provider-Based Status On or After October
] 1, 2002
A-03-031 [sbull Medicare Secondary Payer Information
] Collection Policies Changed for Hospitals
A-03-032 [sbull Addition of Patient Status Code 43,
] Deletion of Patient Status Codes 71 and
72, and Information on New Patient Status
Code 65
A-03-033 [sbull End-Stage Renal Disease Reimbursement for
] Automated Multi-Channel Chemistry Tests
A-03-034 [sbull Modification to Medicare Timely Filing Edit
] for Claims Paid Under Certain Prospective
Payment Systems
A-03-035 [sbull Reporting of Revenue Codes Under the
] Outpatient Prospective Payment System
A-03-036 [sbull Installation of Version 30.0 of the
] Provider Statistical and Reimbursement
Reporting System--Modification
A-03-037 [sbull Contractor Reporting of Operational and
] Workload Data for Electronic Data
Interchange and Manual Transactions
A-03-038 [sbull Program Integrity Management Reporting
] System for Part A Phase 2
A-03-039 [sbull Clarification to Corrections to Updated
] Instruction on Receipt and Processing of
Non-Covered Changes on Other Than Part A
Inpatient Claims (Transmittals A-02-071, A-
02-117)--Change In Effective and
Implementation Date Only
A-03-040 [sbull Clarification of Bill Types 22x and 23x
] Submitted by Skilled Nursing Facilities
A-03-041 [sbull Health Insurance Portability and
] Accountability Act Version 4010A1
...... Institutional 837 Health Care Claim
Additional Implementation Direction
A-03-042 [sbull Updated Revision to Change Request 2508,
] Suspension, Offset, and Recoupment of
Medicare Payment to Providers and
Suppliers of Services
A-03-043 [sbull Changes to Fiscal Year 2001 Nursing and
] Allied Health Education Payment Policies
A-03-044 [sbull Audit Guidance Pertaining To Write-Offs of
] Small Debit Balances in Patients' Accounts
Receivable
A-03-045 [sbull Payment to Hospitals and Units Excluded
] From the Acute Inpatient Prospective
Payment System for Direct Graduate Medical
Education and Nursing and Allied Health
Education for Medicare+Choice Enrollees
A-03-046 [sbull Demonstration--Settlement of Payment for
] Home Health Services to Beneficiaries
Eligible for Both Medicare and Medicaid in
Connecticut, and Massachusetts. Regional
Home Health Intermediaries Only.
A-03-047 [sbull Medicare's Coordination of Benefits
] Contractor Shall Discontinue the
Dissemination of the Right of Recovery
Letter to Intermediaries
A-03-048 [sbull July Outpatient Code Editor Specifications
] Version (V4.2)
A-03-049 [sbull Fiscal Intermediaries Must Install and Use
] Super Op With the Fiscal Intermediary
Standard System
A-03-050 [sbull July Medicare Outpatient Code Editor
] Specifications Version 18.2 for Bills From
Hospitals That Are Not Paid Under the
Outpatient Prospective Payment System
A-03-051 [sbull July 2003 Update of the Hospital Outpatient
] Prospective System
A-03-052 [sbull Revision to Billing for Swing-Bed Services
] Under the Skilled Nursing Facility
Prospective Payment System
[[Page 55623]]
A-03-053 [sbull Nurse Practitioner Services Under Medicare
] Hospice
A-03-054 [sbull Revision to Change Request 2573,
] Transmittal A-03-013, dated February 14,
2003: 3-Day Payment Window Refinements
Under the Short-Term Hospital Inpatient
Prospective Payment System
A-03-055 [sbull Disclosure of Information Requirements
] Related to Hospice Claims
A-03-056 [sbull Payment Update for Long-Term Care Hospital
] Prospective Payment System Rate Year 2004
--------------------
Program Memorandum Carriers
(CMS Pub. 60B)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
B-03-023 [sbull Correct Payment of January and February
] 2003 Physician Services
B-03-024 [sbull Follow-Up to Implementation of the National
] Council for Prescription Drug Programs
Telecommunications Standard Version 5.1
and the Equivalents
...... Batch Standard Version 1.1 for Retail
Pharmacy Drug Transactions
B-03-025 [sbull Durable Medical Equipment Regional
] Carriers--DeWall Posture Protector
Orthotic Body Jacket (L0430)
B-03-026 [sbull Standard System Acceptance of Primary Payer
] Information at the Line Level
B-03-027 [sbull Implementation of Carriers Jurisdiction
] Manual Instructions Based on the Medicare
Carriers Manual Part 3, Section 3101 for
the Multi-Carrier System
...... Standard System and Associated Medicare
Carriers
B-03-028 [sbull Durable Medical Equipment Regional
] Carriers--Internal Classification of
Diseases--9--Classification of Diseases
Coding
B-03-029 [sbull Manager Care Reasonable Charge Data
] Disclosure Requirements for Ambulance
Services
B-03-030 [sbull Types of Services Corrections
]
B-03-031 [sbull Multi-Carriers System Reporting of 2003
] Participating Data to the Contractor
...... Reporting of Operational and Workload Data
System
B-03-032 [sbull Continuation of April and July 2003 Change
] Requests (2423 and 2524): Create Import/
Export Functionality Between the Unique
Provider Identification Number System and
the Provider Enrollment Chain Ownership
System
B-03-033 [sbull Continuation of April and July 2003 Change
] Requests (2425 and 2525): Create Import/
Export Functionality Between the Medicare
Claims System and the Provider Enrollment
Chain Ownership System
B-03-034 [sbull Continuation of April and July 2003 Change
] Requests (2426 and 2526): Process All
Medicare Part B Provider Enrollments in
the Provider Enrollment Chain Ownership
System. Modify the Medicare Claims System
To Incorporate All Claim Payment and
Provider Correspondence Functionality That
Is Included in the Provider Enrollment
System But Will Not Be a Part of Provider
Enrollment Chain Ownership System
B-03-035 [sbull Continuation of April and July 2003 Change
] Requests (2427 and 2527): Process All
Medicare Part B Provider Enrollments in
the Provider Enrollment Chain Ownership
System. Create Import/Export Functionality
Between the Viable Information Processing
Systems Medicare System and Provider
Enrollment Chain Ownership System
B-03-036 [sbull Expansion of Beneficiary History and Claims
] In Process Files in the Viable Information
Processing System Phase 1--Beneficiary
History File Expansion
B-03-037 [sbull Excluding From Home Health Consolidated
] Billing Edits Claims for Therapy Services
Rendered by Physicians
B-03-038 [sbull Oral Anti-Cancer Drugs
]
B-03-039 [sbull Common Working File Skilled Nursing
] Facility Consolidated Billing Bypass To
Allow Separate Payment for Drugs
B-03-040 [sbull Update of the Place of Services Code Set
]
B-03-041 [sbull National Council for Prescription Drug
] Program Batch Transaction Standard 1.1
Billing Request Companion Document
B-03-042 [sbull Bi-Annual Updates to the Health Care
] Provider Taxonomy Code
B-03-043 [sbull Diabetes Outpatient Self-Management
] Training and the ``Incident To'' Provision
B-03-044 [sbull Correction to Business Requirements 2
]
B-03-045 [sbull International Classification of Diseases
] 9th Edition Clinical Modification Coding
...... Requirements for Claims Submitted to
Medicare Carriers
B-03-046 [sbull Provider Education: Establishing New
] Requirements for ICD-9-CM Coding on Claims
Submitted to Medicare Carriers--Increased
Role for Physicians/Practitioners
B-03-047 [sbull Changes To Correct Coding Edits, Version
] 9.3, Effective October 1, 2003
B-03-048 [sbull Addition of Temporary Codes Q4052 and Q4053
]
B-03-049 [sbull Additional Instructions To Assist in the
] Implementation of Program Memorandum B-02-
075--Carrier Review of Payment Amounts for
Portable X-Ray Transportation Services
Health Care Procedure Coding System
--------------------
Program Memorandum
Intermediaries/Carriers
(CMS Pub. 60A/B)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
AB-03-041 [sbull Common Working File Reject and Utilization
] Edits and Carriers Resolution for
Consolidated Billing for Skilled Nursing
Facility Residents
AB-03-042 [sbull Coverage and Billing for Percutaneous Image-
] Guided Breast Biopsy
AB-03-043 [sbull Addition of ``K'' Codes for Surgical
] Dressings
AB-03-044 [sbull Addition of Temporary ``K'' Codes
]
AB-03-045 [sbull Addition of Temporary ``K'' Codes
]
AB-03-046 [sbull Expanding the Number of Source Identifiers
] for Common Working File Medicare Secondary
Payor
AB-03-047 [sbull Single Drug Pricer Clarifications
]
AB-03-048 [sbull End-Stage Renal Disease Coordination Period
]
AB-03-049 [sbull Clarification of Payment Responsibilities
] of Fee-for-Service Contractors as They
Relate to Hospice Members Enrolled in
Managed Care Organizations and Claims
Processing Instructions for Processing
Rejected Claims
[[Page 55624]]
AB-03-050 [sbull Data Center Testing and Production--
] Electronic Correspondence Referral System
User Manual 5.1 and Quick Reference Guide
Replacement
AB-03-051 [sbull Notice of Interest Rate for Medicare
] Overpayments and Underpayments
AB-03-052 [sbull Managing Medicare Appeals Workloads in
] Fiscal Year 2003
AB-03-053 [sbull Availability of Online Screens for the
] Laboratory National Coverage
Determinations
AB-03-054 [sbull Diagnosis Code for Screening Pap Smear and
] Pelvic Examination Services
AB-03-055 [sbull Shared System Maintainer Hours for
] Resolution of Problems Detected During
Health Insurance Portability and
Accountability Act Transaction Release
Testing
AB-03-056 [sbull New Waived Test--March 21, 2003
]
AB-03-057 [sbull Implementation of the Financial Limitation
] for Outpatient Rehabilitation Services
AB-03-058 [sbull Collection of Fee-for-Service Payments Made
] During Periods of Managed Care Enrollment
AB-03-059 [sbull Shared Systems Changes for Name Change From
] Health Care Financing Administration to
Centers for Medicare & Medicaid Services
(Fiscal Intermediary Standard and VIPS
Medicare System External Changes Only)
AB-03-060 [sbull Flat File Changes in the Health Care Claim
] Professional (837 Professional) Version
4010A1, Health Care Claim Payment/Advice
(835) Version 4010 and 4010A1 and 3051.4A,
and Health Care Claim Status Inquiry and
Response (276/277) Version 4010A1
Transactions
AB-03-061 [sbull Program Memorandum on Written Statements of
] Intent To Claim Medicare Benefits
AB-03-062 [sbull New Common Working File Edits and Standard
] System Responses on Skilled Nursing
Facility Claims
AB-03-063 [sbull New Common Working File Medicare Secondary
] Payer Edit to Reject Medicare Secondary
Edit Records for Medicare Beneficiaries
Who Are Only Entitled To Medicare Part B,
and Are Covered by a Group Health Plan
AB-03-064 [sbull System Networking Electronic Correspondence
] Referral System User Guide
AB-03-065 [sbull Schedule Release for July Updates to
] Software Programs and Pricing/Coding Files
AB-03-066 [sbull Issuance of the Eligibility File-Based
] Standard Trading Partner Agreement for the
Purpose of Coordination of Benefits
AB-03-067 [sbull Revision to Change Request 2170: Appeals
] Quality Improvement and Data Analysis
Activities
AB-03-068 [sbull Common Working File Change for the 270/271
] Eligibility Transaction
AB-03-069 [sbull Clarification of the Criteria for a Valid
] Written Statement of Intent To File a
Medicare Claim
AB-03-070 [sbull Second Update to the 2003 Medicare
] Physician Fee Schedule Database
AB-03-071 [sbull July Quarterly Update for 2003 Durable
] Medical Equipment, Prosthetics, Orthotics,
and Supplies Fee Schedule
AB-03-072 [sbull Mammography Computer-Aided Detection
] Equipment
AB-03-073 [sbull Provider Education Article: Financial
] Limitation of Claims for Outpatient
Rehabilitation Services
AB-03-074 [sbull Instructions for Fiscal Intermediary
] Standard System and Multi-Carrier System
Healthcare Integrated General Ledger
Accounting System Changes
AB-03-075 [sbull Provider Education Article: Quarterly
] Provider Update
AB-03-076 [sbull Remittance Advice Message for Denial of
] Clinical Diagnostic Laboratory Services
Denied Due to Frequency Edits
AB-03-077 [sbull Revised Disclosure Desk Reference for Call
] Centers
AB-03-078 [sbull Medicare Fee-for-Service Contractor
] Guidance of the Health Insurance
Portability and Accountability Act Privacy
Rule Business Associate Provisions
AB-03-079 [sbull Claims Processing Instructions for the Utah
] Graduate Medical Education Demonstration
AB-03-080 [sbull Single Drug Pricer Clarification for Code
] J7342
AB-03-081 [sbull Data Center Testing and Production--
] Electronic Correspondence Referral System
User Manual 6.0
AB-03-082 [sbull Medicare Secondary Payer Prepayment and
] Postpayment Workload Reporting--Activity
Code Definitions
AB-03-083 [sbull Screening of Complaints Alleging Fraud and
] Abuse
AB-03-084 [sbull Changes to the Laboratory National Coverage
] Determination Edit Software for July 1,
2003
AB-03-085 [sbull Beneficiary Notice of Implementation of
] Outpatient Therapy Service Limitations
AB-03-086 [sbull New Automatic Notice of Change to Medicare
] Secondary Payer Auxiliary File
AB-03-087 [sbull Common Working File Edits With Unsolicited
] Responses for Skilled Nursing Facility
Consolidated Billing
AB-03-088 [sbull Prohibition on New Trading Partner
] Agreements With Certain Entities for the
Purpose of Coordination of Benefits
AB-03-089 [sbull Coverage and Billing for Home Prothrombin
] Time International Normalized Ratio
Monitoring for Anticoagulation Management
AB-03-090 [sbull Coverage of Compression Garments in the
] Treatment of Venous Stasis Ulcers
AB-03-091 [sbull Medicare Contractor Annual Update of the
] International Classification of Diseases,
Ninth Revision, Clinical Modification
AB-03-092 [sbull Expanded Coverage of Positron Emission
] Tomography Scans and Related Claims
Processing Requirements for Thyroid Cancer
and Perfusion of the Heart Using Ammonia N-
13
AB-03-093 [sbull Correction: Coverage and Billing
] Requirements for Electrical Stimulation
for the Treatment of Wounds
--------------------
Hospice Manual
(CMS Pub. 10)
(Superintendent of Documents No. HE 22.8/2)
------------------------------------------------------------------------
800 [sbull Screening Pap Smears and Screening Pelvic
] Examinations
801 [sbull Notice to Beneficiaries
]
...... Peer Review Organization Monitoring of
Hospital Admission Notice to Beneficiaries
802 [sbull Frequency of Billing
]
803 [sbull Magnetic Resonance Angiography
]
804 [sbull Screening Pap Smears and Screening Pelvic
] Examinations
805 [sbull International Classification of Diseases
] 9th Edition Clinical Modification
--------------------
[[Page 55625]]
Home Health Agency Manual
(CMS Pub. 11)
(Superintendent of Documents No. HE 22.8/5)
------------------------------------------------------------------------
304 [sbull Frequency of Billing
]
--------------------
Coverage Issues Manual
(CMS Pub. 6)
(Superintendent of Documents No. HE 22.8/14)
------------------------------------------------------------------------
169 [sbull Stem Cell Transplantation
]
170 [sbull Magnetic Resonance Angiography
]
171 [sbull Positron Emission Tomography Scans
]
172 [sbull Intestinal and Multi-Visceral
] Transplantation
--------------------
Peer Review Organization
(CMS Pub. 19)
(Superintendent of Documents No. 22.8/8-15)
------------------------------------------------------------------------
90 [sbull Eligibility--has been moved to the Pub. 100-
] 10, Medicare Quality Improvement
Organizations Manual, Chapter 2, which can
be found at http://www.cms.hhs.gov/
manuals.
...... Data Management--has been moved to the Pub.
100-10, Medicare Quality Improvement
Organizations Manual, Chapter 8, which can
be found at http://www.cms.hhs.gov/
manuals.
...... Management--has been moved to the Pub. 100-
10, Medicare Quality Improvement
Organizations Manual, Chapter 13, which
can be found at http://www.cms.hhs.gov/
manuals.
...... Performance Evaluation--has been moved to
the Pub. 100-10, Medicare Quality
Improvement Organizations Manual, Chapter
15, which can be found at http://www.cms.hhs.gov/manuals
.
--------------------
Hospice Manual
(CMS Pub. 21)
(Superintendent of Documents No. HE 22. 8/18)
------------------------------------------------------------------------
67 [sbull Frequency of Billing
]
--------------------
Rural Health Clinic Manual & Federally Qualified Health Centers Manual
(CMS Pub. 27)
(Superintendent of Documents No. He 22. 8/19:985)
------------------------------------------------------------------------
38 [sbull Magnetic Resonance Angiography
]
--------------------
Rural Dialysis Facility Manual (Non-Hospital Operated)
(CMS Pub. 29)
(Superintendent of Documents No. 22.8/13)
------------------------------------------------------------------------
95 [sbull Frequency of Billing
]
--------------------
Provider Cost Reporting Forms and Instructions
Provider Reimbursement Manual--Part 2
------------------------------------------------------------------------
Chapter 36/Form CMS-2552-96
(CMS Pub. 15-2-36)
(Superintendent of Documents No. HE 22.8/4)
------------------------------------------------------------------------
10 [sbull Hospital Healthcare Complex Cost Report
]
--------------------
Program Integrity Manual
(CMS Pub. 100-08)
------------------------------------------------------------------------
40 [sbull Local Provider Education and Training
] Program
41 [sbull Definitions Related To Enrollment
]
...... Benefit Integrity/Payment Safeguard
Contractor vs. Provider Enrollment
Contractors
...... Forms Disposition
...... Processing the Application
...... Identification
...... Adverse Legal Actions
...... Practice Location
...... Ownership and Managing Control Information
(Organizations)
...... Ownership and Managing Control Information
(Individuals)
...... Delegated Official
...... Ambulance Services Suppliers
...... Certified Basic Life Support
...... Independent Diagnostic Testing Facilities--
Attachment 1
...... Entities That Must Enroll as Independent
Diagnostic Testing Facilities
[[Page 55626]]
...... Review of Attachment 2, Independent
Diagnostic Testing Facility
...... Enrollment Checks
...... Special Consideration
...... Reassignment of Benefits--Form CMS-855R
...... Reassignment of Benefits Statement
...... Attestation Statement
...... Enrolling Certified Suppliers Who Enroll
With Carrier
...... Managed Care Organization
...... Application Sectional Instructions for
Intermediaries
...... Processing the Application
...... Provider Identification
...... Adverse Legal Actions
...... Practice Location
...... Ownership and Managing Control Information
(Organizations)
...... Chain Home Office Information
...... Billing Agency
...... Staffing Company
...... Capitalization Requirements for Home Health
Agencies
...... Contact Person
...... Certification Statement
...... Delegated Official
...... Special Processing Situation
...... Community Mental Health Centers
...... Benefit Improvement and Protection Act of
2000 Provisions
...... Community Mental Health Centers Enrollment
and Change of Ownership
...... Site Visit
...... Process
...... Deactivation of Billing Numbers for
Inactive Community Mental Health Centers
...... State Survey Regional Office Process
...... Changes of Information--New Form CMS-855
Data
...... Change Requirement
...... Procedures for Request for Additional
Information, Approval, Denial or
Transmission of Recommendations
...... Request for Additional Information
...... Approval and Recommendations for Approval
...... Denials
...... Failure to Sign and/or Date the Application
...... Revocations
...... Time Frame for Application Processing
...... Matrix
...... Verification and Validation of Information
...... Fraud Investigation Database
...... Healthcare Integrity and Protection Data
Bank
...... Excluded Parties List System
...... Enrollment of Hospitals, Assignment of
Billing Numbers
...... Provider-Based Processing and Changes in
Status
...... Web Site
...... File Maintenance and Review
42 [sbull Effectuating Favorable Final Appellate
] Decisions That a Beneficiary Is Confined
To Home
43 [sbull Medical Records Information Reported
] Electronically
...... Electronic Media Claim Flat File Record for
End-Stage Renal Disease
...... Argus Filed Descriptions and Formats
--------------------
Managed Care Manual
(Pub. 100-16)
------------------------------------------------------------------------
23 [sbull Introduction
]
...... General Requirements
...... Basic Rule
...... Services of Noncontracting Providers and
Suppliers
...... Types of Benefits
...... Availability and Structure of Plans
...... Terms of Medicare+Choice Plans
...... Multiple Plans in One Service Area
...... Centers for Medicare & Medicaid Services
Review and Approval of Medicare+Choice
Benefits
...... Requirements Relating To Medicare
Conditions of Participation
...... Provider Networks
...... Requirements Relating To Benefits
...... Basic Benefits
...... Additional Benefits
...... Supplemental Benefits--Mandatory
Supplemental and Optional Supplemental
[[Page 55627]]
...... Basic Versus Supplemental Benefits
...... Medicare Covered Benefits
...... Medicare+Choice Medical Savings Account
Plan Benefits
...... General Rule
...... Countable Expenses
...... Services After the Deductible
...... Balance Billing
...... The Annual Deductible
...... Special Rules on Supplemental Benefits for
Medicare+Choice Medical Savings Account
Plans
...... Point of Service Option
...... General Rule
...... Accessing Plan Contracting Providers
...... Financial Cap
...... Enrollee Information and Disclosure
...... Prompt Payment
...... Point of Services Related Data
...... Services Area
...... Definition
...... Factors That Influence Service Area
Approvals
...... The ``County Integrity Rule''
...... Coordination of Benefits With Employer
Group Health Plans and Medicaid
...... General Rule
...... Requirements, Rights, and Beneficiary
Protection
...... Medicare Secondary Payer Procedures
...... Basic Rule
...... Responsibilities of the Medicare+Choice
Organization
...... Medicare Benefits Secondary to Group Health
Plans and Large Group Health Plans
...... Collecting From Other Entities
...... Collecting From Other Insurers or the
Enrollee
...... Collecting From Group Health Plans and
Large Group Health Plans
...... Medicare Secondary Payor
...... National Coverage Determinations and
Legislative Changes in Benefits
...... Definitions
...... General Rules
...... Sources for Obtaining Information
...... Discrimination Against Beneficiaries
Prohibited
...... General Prohibition
...... Additional Requirements
...... A Medicare+Choice Organization's
Responsibility
...... Disclosure Requirements
...... Introduction
...... Disclosure Requirements at Enrollment (and
Annually Thereafter)
...... Disclosure Upon Request
...... Information Pertaining to a Medicare+Choice
Organization Changing Its Rules or
Provider Network
...... Other Information That Is Disclosable
...... Access to (and Availability of ) Service
...... Introduction
...... Access and Availability Rule for
Coordinated Care Plans
...... Rules for All Medicare+Choice Organizations
to Ensure Continuity of Care
...... Ambulance, Emergency, and Urgently Needed,
and Post-Stabilization Care Services
Ambulance
...... Emergency and Urgently Needed Services
...... Post-Stabilization Care Services
...... Confidentiality and Accuracy of Enrollee
Records
...... General Rule
...... Private Fee-for-Service Plans
...... Information on Advance Directives
...... Definition
Basic Rule
State Law Primary
Content of Enrollee Information and Other
Medicare+Choice Obligations
Incapacitated Enrollees
Community Education Requirements
Medicare+Choice Organization Rights
Appeal and Anti-Discrimination Rights
[[Page 55628]]
24 [sbull Introduction
] Provider Involvement in Policy-Making
Physician Consultation in Medical Policies
Consultation in Development of
Credentialing Policies
Written Information on Physician
Participation
Interference With Health Care
Professionals' Advice to Enrollees
Prohibited
Provider Anti-Discrimination
Provider Participation
Notice of Reason for Not Granting
Participation
Confirmation of Eligibility for
Participation in Medicare Excluded and
Outpatient Physical Therapy and Opt-Out
Provider Checks
Credentialing, Monitoring, and
Recredentialing
Suspension, Termination, or Nonrenewal of
Physician Contract
Institutional Provider and Supplier
Certification
Physician Incentive Plans
Requirements and Limitations
Disclosure of Physician Incentive Plans
Provider Indemnification of Medicare+Choice
Organization Prohibited
Special Rules for Services Furnished by Non-
Contract Provider
25 [sbull Introduction
] Terminology
Rules Governing Premiums and Cost Sharing
Monthly Premiums
Uniformity of Premiums
Segmented Services Area Option
...... Timing of Payments
Monetary Inducements Prohibited
Submission of Proposed Premiums and Related
Information
General Rule
Information Required for Coordinated Care
Plans and Private Fee-For-Service Plans
Average Payment Rate
Centers for Medicare & Medicaid Services
Review
Limits on Premiums and Cost-Sharing Amounts
Rules for Coordinated Care Plans
Rules for Medicare+Choice Private Fee-for-
Service Plans
Special Rules for Mid-Year (Benefit)
Enhancement
General Rule
Incorrect Collections of Premiums and Cost
Sharing Definitions
Refund Methods
Reduction by Centers for Medicare &
Medicaid Services
Adjusted Community Rate Process
General Information
Standard Method
Initial Rate Calculation
Initial Rate Adjustment by Medicare+Choice
Organization
Initial Rate Adjustment by Centers for
Medicare & Medicaid Services
Other Methods for Computing Adjusted
Community Rate
Special Rule for Centers for Medicare &
Medicaid Services Average Payment
Rate or Adjusted Community Rate Calculation
Centers for Medicare and Medicaid Services
Review
Sufficiency of Documentation and Periodic
Audits
Requirement for Additional Benefits--42
Code of Federal Regulations 422.312
Definitions
General Information
Stabilization Fund
Establishment of a Stabilization Fund
Limit Per Contract Period
Exception to the Limit Per Contract Period
Cumulative Limit
Interest on and Accounting of Reserved
Funds
Withdrawal From a Stabilization Fund
Criteria for Centers for Medicare &
Medicaid Services Approval
...... Basis for Denial
...... Form of Payment
...... Additional Benefits
...... Part B Premium Reduction As an Additional
Benefit
...... Additional Health Care Benefits
...... Reduction of Charges to Enrollees for Basic
Benefits
...... Additional Supplemental Health Care
Benefits and Related Premiums
[[Page 55629]]
...... Detailed Instructions
...... Enrollees Who Elect Hospice While Remaining
Enrolled in a Medicare+Choice Plan
...... Hospice Benefits
...... Medicare+Choice Non-Medicare-Covered
Benefits
...... Medicare+Choice Medicare-Covered Benefits
(Except Hospice)
...... Medicare+Choice Non-Medicare-Covered
Benefits
...... Enrollees with End-Stage Renal Stage
Disease User Fees
...... End-Stage Renal Disease Network Fee
...... Information Campaign User Fee
...... Waivers for Medicare+Choice Organization
Contracts With Employer or Union Groups
...... Background
...... Section 617 Waiver Categories Approved
...... Service Areas
...... Adjusted Community Rate Filings
...... Coordination of Benefits
...... Effect on Medicare+Choice Plan Cash Flow
...... Effect on Adjusted Community Rate
Calculations
------------------------------------------------------------------------
Addendum IV.--Regulation Documents Published in the Federal Register
[April 2003 Through June 2003]
----------------------------------------------------------------------------------------------------------------
FR vol. 68
Publication date page No. CFR parts affected File code Title of regulation
----------------------------------------------------------------------------------------------------------------
April 2, 2003............ 15973 42 CFR Part 440... CMS-2132-P........ Medicaid Program; Provider
Qualifications for
Audiologists.
April 4, 2003............ 16652 42 CFR Parts 422 CMS-4024-FC....... Medicare Program; Improvements
and 489. to the Medicare+Choice Appeal
and Grievance Procedures.
April 16, 2003........... 18654 CMS-1256-N........ Medicare Program; Notice of
Ambulance Fee Schedule in
Accordance With Federal
District Court Order.
April 17, 2003........... 18895 45 CFR Part 160... CMS-0010-IFC...... Civil Money Penalties:
Procedures for Investigations,
Imposition of Penalties, and
Hearings.
April 25, 2003........... 22268 42 CFR Parts 405, CMS-1203-CN....... Medicare Program; Changes to the
412, 413, and 485. Hospital Inpatient Prospective
Payment Systems and Fiscal Year
2003 Rates; Correction.
April 25, 2003........... 22064 42 CFR Parts 420, CMS-6002-P........ Medicare Program; Requirements
424, 489, and 498. for Establishing and
Maintaining Medicare Billing
Privileges.
April 25, 2003........... 20394 .................. CMS-1251-N........ Medicare Program; Meeting of the
Practicing Physicians Advisory
Council--May 19, 2003.
April 25, 2003........... 20393 .................. CMS-4052-N........ Medicare Program: Meeting of the
Advisory Panel on Medicare
Education--May 21, 2003.
April 25, 2003........... 20391 .................. CMS-2182-PN....... Medicare and Medicaid Programs;
Application by the Community
Health Accreditation Program
(CHAP) for Continued Approval
of Deeming Authority for
Hospices.
April 25, 2003........... 20349 42 CFR Parts 422 CMS-4024-CN....... Medicare Program; Improvements
and 489. to the Medicare+Choice Appeal
and Grievance Procedures;
Correction.
April 25, 2003........... 20347 42 CFR Part 411... CMS-1809-F3....... Medicare and Medicaid Programs;
Physicians' Referrals to Health
Care Entities With Which They
Have Financial Relationships:
Extension of Partial Delay of
Effective Date.
April 28, 2003........... 22453 45 CFR Part 160... CMS-0010-IFC (OFR) Civil Money Penalties:
Correction). Procedures for Investigations,
Imposition of Penalties, and
Hearings; Correction.
May 2, 2003.............. 23410 45 CFR Part 148... CMS-2179-FC....... Grants to States for Operation
of Qualified High Risk Pools.
May 16, 2003............. 26786 42 CFR Part 412... CMS-1474-P........ Medicare Program; Inpatient
Rehabilitation Facility
Prospective Payment System for
FY 2004.
May 16, 2003............. 26758 42 CFR Parts 409, CMS-1469-P........ Medicare Program; Prospective
413, 440, and 483. Payment System and Consolidated
Billing for Skilled Nursing
Facilities--Update.
May 16, 2003............. 26621 .................. CMS-4060-N........ Medicare Program; Town Hall
Meeting on the Refinement of
the Minimum Data Set (MDS),
Version 3.0.
May 19, 2003............. 27154 42 CFR Parts 412 CMS-1470-P........ Medicare Program; Proposed
and 413. Changes to the Hospital
Inpatient Prospective Payment
Systems and Fiscal Year 2004
Rates.
May 29, 2003............. 32053 .................. CMS-2185-N........ Fiscal Year 2003 Program
Announcement; Availability of
Funds and Notice Regarding
Applications.
May 30, 2003............. 32528 .................. CMS-2177-FN....... Medicare and Medicaid Programs;
Approval of the Joint
Commission on Accreditation of
Healthcare Organizations
(JCAHO) for Deeming Authority
for Hospices.
May 30, 2003............. 32527 .................. CMS-3116-N........ Medicare Program; Request for
Nominations for Members for the
Medicare Coverage Advisory
Committee.
[[Page 55630]]
May 30, 2003............. 32406 42 CFR Part 416... CMS-1885-CN....... Medicare Program; Update of
Ambulatory Surgical Center List
of Covered Procedures Effective
July 1, 2003.
May 30, 2003............. 32400 42 CFR Parts 410, CMS-1204-CN....... Medicare Program; Revisions to
414, and 485. Payment Policies Under the
Physician Fee Schedule for
Calendar Year 2003 and
Inclusion of Registered Nurses
in the Personnel Provision of
the Critical Access Hospital
Emergency Services Requirement
for Frontier Areas and Remote
Locations.
June 4, 2003............. 33579 42 CFR Parts 412 CMS-1470-P (OFR Medicare Program; Proposed
and 413. Correction). Changes to the Hospital
Inpatient Prospective Payment
Systems and Fiscal Year 2004
Rates.
June 4, 2003............. 33495 .................. CMS-5003-N........ Medicare Program; Demonstration:
End-Stage Renal Disease--
Disease Management.
June 6, 2003............. 34122 42 CFR Part 412... CMS-1472-F........ Medicare Program; Prospective
Payment System for Long-Term
Care Hospitals: Annual Payment
Rate Updates and Policy
Changes.
June 9, 2003............. 34494 42 CFR Part 412... CMS-1243-F........ Medicare Program; Change in
Methodology for Determining
Payment for Extraordinarily
High-Cost Cases (Cost Outliers)
Under the Acute Care Hospital
Inpatient and Long-Term Care
Hospital Prospective Payment
Systems.
June 9, 2003............. 34492 42 CFR Parts 412 CMS-1470-P (OFR Medicare Program; Proposed
and 413. Correction). Changes to the Hospital
Inpatient Prospective Payment
Systems and Fiscal Year 2004
Rates; Correction.
June 10, 2003............ 34768 42 CFR Part 413... CMS-1469-P2....... Medicare Program; Prospective
Payment System and Consolidated
Billing for Skilled Nursing
Facilities--Update.
June 27, 2003............ 38370 .................. CMS-1259-N........ Medicare Program; Public Meeting
in Calendar Year 2003 for New
Clinical Laboratory Tests
Payment Determinations.
June 27, 2003............ 38370 .................. CMS-5003-N2....... Medicare Program; Extension of
Date of Submissions and
Informational Meeting on the
Application Process for the End-
Stage Renal Disease--Disease
Management Demonstration.
June 27, 2003............ 38359 .................. CMS-9017-N........ Medicare and Medicaid Programs;
Quarterly Listing of Program
Issuances--January 2003 Through
March 2003.
June 27, 2003............ 38346 .................. CMS-4062-N........ Medicare and Medicaid Programs;
Solicitation for Information on
the Hospital CAHPS.
June 27, 2003............ 38345 .................. CMS-1257-N........ Medicare Program: Notice of the
Practicing Physicians Advisory
Council Rechartering.
June 27, 2003............ 38269 .................. CMS-6012-N6....... Medicare Program; Negotiated
Rulemaking Committee on Special
Payment Provisions and
Requirements for Prosthetics
and Certain Custom-Fabricated
Orthotics; Meeting
Announcement.
June 27, 2003............ 38206 45 CFR Part 146... CMS-2152-F........ Amendment to the Interim Final
Regulation for Mental Health
Parity.
----------------------------------------------------------------------------------------------------------------
Addendum V.--National Coverage Determinations, April 2003 Through June
2003
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 became effective 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 impending decisions or, in some cases, explain
why it was not appropriate to issue an NCD. We identify completed
decisions by section of the Coverage Issues Manual (CIM) 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 Web site at http://cms.hhs.gov/coverage.
National Coverage Decisions
[April 2003 Through June 2003]
----------------------------------------------------------------------------------------------------------------
CIM section Title Issue date Effective date
----------------------------------------------------------------------------------------------------------------
Coverage Issues Manual (CIM) (CMS Pub. 06)
----------------------------------------------------------------------------------------------------------------
50-14............................ Magnetic Resonance Angiography of the Abdomen 05/09/03 07/01/03
and Pelvis.
35.85.1.......................... Implantable Automatic Defibrillators......... 06/06/03 10/01/03
50-36............................ PET for Thyroid Cancer....................... 06/20/03 10/01/03
50-36............................ PET for Soft Tissue Sarcoma.................. 06/20/03 10/01/03
50-36............................ PET for Alzheimer's Disease/Dementia......... 06/20/03 10/01/03
[[Page 55631]]
50-36............................ PET for Myocardial Perfusion of the Heart 06/20/03 10/01/03
Using Ammonia N-13.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
PM No. Title Issue date Effective date
Program Memorandum (PM)
----------------------------------------------------------------------------------------------------------------
AB-03-084........................ Changes to the Laboratory NCD Edit Software 06/06/03 07/01/03
For 07/03 (Blood Counts, Blood Glucose
Testing, HIV Testing).
----------------------------------
----------------------------------------------------------------------------------------------------------------
Addendum VI.--Categorization of Food and Drug Administration-Allowed
Investigational Device Exemptions
Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices
fall into one of three classes. Also, under the new categorization
process to assist CMS, the Food and Drug Administration (FDA)
assigns each device with an FDA-approved investigational device
exemption (IDE) to one of two categories. Category A refers to
experimental/investigational device exemptions, and Category B
refers to nonexperimental/investigational device exemptions. 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 information presents the device number and
category (A or B) for the second quarter, April through June 2003.
Investigational Device Exemption Numbers, 2nd Quarter 2003
------------------------------------------------------------------------
IDE Category
------------------------------------------------------------------------
G010175..................................................... B
G010354..................................................... B
G020083..................................................... B
G020115..................................................... A
G020230..................................................... B
G020231..................................................... B
G020244..................................................... B
G020273..................................................... B
G020307..................................................... B
G020319..................................................... B
G020323..................................................... B
G030001..................................................... B
G030007..................................................... B
G030034..................................................... B
G030044..................................................... B
G030045..................................................... B
G030051..................................................... B
G030054..................................................... B
G030055..................................................... B
G030056..................................................... B
G030058..................................................... B
G030061..................................................... B
G030062..................................................... B
G030063..................................................... B
G030064..................................................... B
G030065..................................................... B
G030073..................................................... B
G030074..................................................... B
G030075..................................................... B
G030078..................................................... B
G030080..................................................... B
G030082..................................................... B
G030088..................................................... B
G030089..................................................... B
G030090..................................................... B
G030091..................................................... B
G030095..................................................... B
G030096..................................................... B
G030097..................................................... B
G030101..................................................... B
G030103..................................................... B
G030104..................................................... B
G030105..................................................... A
G030106..................................................... B
G030108..................................................... B
G030109..................................................... B
G030110..................................................... B
G030113..................................................... B
G030114..................................................... B
G030115..................................................... B
G030117..................................................... B
G030118..................................................... B
G030120..................................................... B
G030122..................................................... B
G030124..................................................... B
G030126..................................................... B
G030128..................................................... B
------------------------------------------------------------------------
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:
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Approved CFR sections in title 42, title
45, and title 20 (note: sections in title
OMB control Nos. 45 are preceded by ``45 CFR,'' and sections
in title 20 are preceded by ``20 CFR'')
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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.
0938-0034.................. 405.821.
0938-0035.................. 407.4.
0938-0037.................. 413.20, 413.24.
0938-0041.................. 408.6.
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, 440.250, 440.220, 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 and 455.100-455.106.
[[Page 55632]]
0938-0101.................. 430.3.
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.................. 405.247.
0938-0170.................. 493.1269-493.1285.
0938-0193.................. 430.10-430.20 and 440.167.
0938-0202.................. 413.17, 413.20.
0938-0214.................. 411.25, 489.2, 489.20.
0938-0236.................. 413.20, 413.24.
0938-0242.................. 416.44, 418.100, 482.41, 483.270, 483.470.
0938-0245.................. 407.10, 407.11.
0938-0251.................. 406.7.
0938-0266.................. 416.41, 416.83, 416.47, 416.48.
0938-0267.................. 485.56, 485.58, 485.60, 485.64, 485.66,
410.65.
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.................. 413.17.
0938-0300.................. 431.8.
0938-0301.................. 413.20, 413.24.
0938-0313.................. 418.1-418.405.
0938-0328.................. 482.12, 482.22, 482.27, 482.30,
482.41,482.43,482.53,482.56, 482.57,
482.60, 482.61, 482.62, 482.66.
0938-0334.................. 491.9 Subpart A.
0938-0338.................. 486.104, 486.106, 486.110.
0938-0354.................. 441.6.
0938-0355.................. 484.10-484.52.
0938-0357.................. 409.40-409.50, 410.36, 410.170, 411.4-
411.15, 421.100, 424.22, 484.18 and
489.21.
0938-0358.................. 412.20-412.30.
0938-0359.................. 412.40-412.52.
0938-0360.................. 405.2100-405.2184.
0938-0365.................. 484.10, .11, .12, .14, .16, .18, .20, .36,
.48, .52.
0938-0372.................. 414.33.
0938-0378.................. 482.60-482.62.
0938-0379.................. 418.1-418.405.
0938-0380.................. 482.1-482.66.
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.
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.
0938-0449.................. 440.180, 441.300-441.310.
0938-0454.................. 424.2.
0938-0456.................. 412.105.
0938-0463.................. 413.20, 413.24.
0938-0465.................. 411.404, 411.406, 411.408.
0938-0467.................. 431.17, 431.306, 435.910, 435.920, 435.940-
435.960.
0938-0469.................. 417.107, 417.478.
0938-0470.................. 417.143 and 417.408.
0938-0477.................. 412.92.
0938-0484.................. 424.123.
0938-0486.................. 498.40-498.95.
0938-0501.................. 406.15.
0938-0502.................. 433.138.
0938-0512.................. 486.301-486.325.
0938-0526.................. 475.100 Subpart C, 475.106 and 475.107,
462.102, 462.103.
0938-0534.................. 410.38, 424.5.
0938-0544.................. 493.1-493.2001.
0938-0565.................. 411.20-411.206.
0938-0566.................. 411.404(b)(c), 411.406(d), 411.408(d)(2)
and (f).
0938-0567.................. Part 498 Subpart H, Part 498 Subparts D and
E, and 20 CFR 404.933.
0938-0573.................. 412.256 and 412.230.
0938-0581.................. 493.1-493.2001.
0938-0599.................. 493.1-493.2001.
0938-0600.................. 405.371, 405.378 and 413.20.
[[Page 55633]]
0938-0610.................. 417.436, 417.801, 417.436(d), 422.128,
430.12(c)(1)(ii), 431.20, 31.107, 434.28,
483.10, 484.10(c)(ii), 489.102.
0938-0612.................. 493.1-493.2001.
0938-0618.................. 433.68, 433.74, 447.272.
0938-0653.................. 493.
0938-0655.................. 493.184.
0938-0657.................. 405.2110, 405.2112.
0938-0658.................. 405.2110, 405.2112.
0938-0667.................. 482.12, 488.18, 489.20 and 489.24.
0938-0673.................. 430.1.
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.................. 486.301-486.325.
0938-0690.................. 488.4-488.9, 488.201.
0938-0691.................. 412.106.
0938-0692.................. 466.78, 489.20, and 489.27.
0938-0700.................. 417.479, 417.500; 422.208, 422.210; 434.44,
434.67, 434.70; 1003.100, 1003.101,
1003.103 & 1003.106.
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, and
148.128.
0938-0714.................. 411.370-411.389.
0938-0717.................. 424.57.
0938-0721.................. 410.33.
0938-0722.................. 422.370-422.378.
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.................. Part 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,
and 422.560-422.622.
0938-0768.................. 417.800-417.840.
0938-0770.................. 410.2.
0938-0778.................. 422.64, 422.111, 422.560-422.622.
0938-0779.................. 417.470, 417.126(a), 422.210(h),
422.64(10).
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.................. 491.3, 491.8, 491.11.
0938-0798.................. 413.65, 419.42.
0938-0802.................. 419.43.
0938-0810.................. 482.45.
0938-0819.................. 45 CFR 146.121.
0938-0823.................. 420.41.
0938-0824.................. 482.13(f)(7), 440.10(1)(3)(iii).
0938-0827.................. 45 CFR 146.141.
0938-0829.................. 422.568.
0938-0832.................. 489.
0938-0833.................. 483.350-483.376.
0938-0840.................. 422.152(b)(2).
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, and 457.1180.
0938-0842.................. 412 and 413.
0938-0846.................. 411.1, 411.350-411.357 and 424.22.
0938-0857.................. 419.
0938-0860.................. 419.
0938-0866.................. 45 CFR Part 162.
0938-0872.................. 483.20, 413.337.
0938-0873.................. 422.152.
0938-0874.................. 45 CFR Parts 160 and 162.
0938-0878.................. Part 422 Subparts F and G.
0938-0883.................. 45 CFR Parts 160 and 164.
0938-0887.................. 45 CFR 148.316, 148.318, 148.320.
[[Page 55634]]
0938-0897.................. 412.22, 412.533.
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[FR Doc. 03-24069 Filed 9-25-03; 8:45 am]
BILLING CODE 4120-03-P