[Federal Register Volume 64, Number 234 (Tuesday, December 7, 1999)]
[Notices]
[Pages 68357-68364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31601]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HCFA-9004-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--First Quarter, 1999
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Notice.
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SUMMARY: This notice lists HCFA manual instructions, substantive and
interpretive regulations, and other Federal Register notices that were
published during January, February, and March of 1999, relating to the
Medicare and Medicaid programs. It also identifies certain devices with
investigational device exemption numbers approved by the Food and Drug
Administration that potentially may be covered under Medicare.
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, we are also including all Medicaid
issuances and Medicare and Medicaid substantive and interpretive
regulations (proposed and final) published during this timeframe.
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.
Questions concerning Medicare items in Addendum III may be
addressed to Bridget Wilhite, Office of Communications and Operations
Support, Division of Regulations and Issuances, Health Care Financing
Administration, C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-
1850, (410) 786-5248.
Questions concerning Medicaid items in Addendum III may be
addressed to Betty Stanton, Center for Medicaid State Operations,
Policy Coordination and Planning Group, Health Care Financing
Administration, S2-26-13, 7500 Security Boulevard, Baltimore, MD 21244-
1850, (410) 786-3247.
Questions concerning Food and Drug Administration-approved
investigational device exemptions may be addressed to Sharon Hippler,
Office
[[Page 68358]]
of Clinical Standards and Quality, Coverage and Analysis Group, Health
Care Financing Administration, C4-11-04, 7500 Security Boulevard,
Baltimore, MD 21244-1850, (410) 786-4633.
Questions concerning all other information may be addressed to
Trenesha Fultz, Office of Communications and Operations Support,
Division of Regulations and Issuances, Health Care Financing
Administration, C5-12-08, 7500 Security Boulevard, Baltimore, MD 21244-
1850, (410) 786-3822.
SUPPLEMENTARY INFORMATION:
I. Program Issuances
The Health Care Financing Administration (HCFA) 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
these programs involves (1) furnishing information to Medicare
beneficiaries and Medicaid recipients, health care providers, and the
public and (2) effective communications with regional offices, State
governments, State Medicaid Agencies, State Survey Agencies, various
providers of health care, fiscal intermediaries and carriers 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, 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, we are continuing our practice of including Medicare
substantive and interpretive regulations (proposed and final) published
during the 3-month time frame.
II. How To Use the Addenda
This notice is organized so that a reader may review the subjects
of all manual issuances, memoranda, substantive and interpretive
regulations, or Food and Drug Administration-approved investigational
device exemptions published during the timeframe, to determine whether
any are of particular interest. We expect it 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 may wish to review
the August 21, 1989 publication (54 FR 34555).
To aid the reader, we have organized and divided this current
listing into five 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 HCFA Medicare
and Medicaid manuals and memoranda.
Addendum III lists a unique HCFA transmittal number for
each instruction in our manuals or Program Memoranda and its subject
matter. A transmittal may consist of a single instruction or many.
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--
+ Date published;
+ Federal Register citation;
Parts of the Code of Federal Regulations (CFR) that have
changed (if applicable);
Agency file code number;
Title of the regulation;
Ending date of the comment period (if applicable); and
Effective date (if applicable).
Addendum V includes listings of the Food and Drug
Administration-approved investigational device exemption numbers that
have been approved or revised during the quarter covered by this
notice. On September 19, 1995, we published a final rule (60 FR 48417)
establishing in regulations at 42 CFR 405.201 et seq. that certain
devices with an investigational device exemption approved by the Food
and Drug Administration (FDA) and certain services related to those
devices may be covered under Medicare. It is our practice to announce
all investigational device exemption categorizations, using the
investigational device exemption 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
investigational device exemption number).
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, all manuals are available at the following Internet
address: http://www.hcfa.gov/pubforms/progman.htm.
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.access.gpo.gov/su__docs/, by using local WAIS client software, or
by telnet to swais.access.gpo.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).
[[Page 68359]]
C. Rulings
We publish rulings on an infrequent basis. Interested individuals
can obtain copies from the nearest HCFA 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 HCFA Home
Page. The Internet address is http://www.hcfa.gov/regs/rulings.htm.
D. HCFA'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:
Titles XI, XVIII, and XIX of the Act.
HCFA-related regulations.
HCFA manuals and monthly revisions.
HCFA program memoranda.
The titles of the Compilation of the Social Security Laws are current
as of January 1, 1995. (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, 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 HCFA publication are
shown in Addendum III, along with the HCFA publication and transmittal
numbers. To help FDLs locate the materials, use the Superintendent of
Documents number, plus the HCFA transmittal number. For example, to
find the Intermediary Manual (HCFA Pub. 13-3) transmittal entitled
``Mammography Screening,'' use the Superintendent of Documents No. HE
22.8/6 and the HCFA transmittal number 1754.
(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: November 18, 1999.
Elizabeth Cusick,
Director, Office of Communications and Operations Support.
Addendum I
This addendum lists the publication dates of the most recent
quarterly listings of program issuances.
June 4, 1998 (63 FR 30499)
August 11, 1998 (63 FR 42857)
September 16, 1998 (63 FR 49598)
December 9, 1998 (63 FR 67899)
May 11, 1999 (64 FR 25351)
November 2, 1999 (64 FR 59185)
Addendum II--Description of Manuals, Memoranda, and HCFA 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 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 (57 FR
47468).
Addendum III--Medicare and Medicaid Manual Instructions (January
1999 Through March 1999)
Transmittal No. and Manual/Subject/Publication Number
Intermediary Manual Part 3--Claims Process (HCFA Pub. 13-3)
(Superintendent of Documents No. HE 22.8/6)
1766
File specifications, Records Specifications, and Data
Element Definitions for Electronic Media Claims Bills.
1767
Model Development Letter Questions.
1768
Bed-Hold Policies for Long-Term Care Facilities.
1769
Medicare Rural Hospital Flexibility Program.
Grand fathering Existing Facilities.
Requirements for Critical Access Hospital Services and Critical
Access Hospital Long-term Care Services.
Payment for Services Furnished by a Critical Access Hospital.
Payment for Post-Hospital Skilled Nursing Facilities Care Furnished
by a Critical Access Hospital.
Review of Form HCFA-1450 for the Inpatient.
1770
Comprehensive Medical Review Procedures Using Statistical
Sampling for Overpayment Estimation.
1771
Oral Anti-Nausea Drugs as Full Therapeutic Replacements
for Intravenous Dosage Forms as Part of a Cancer Chemotherapeutic
Regimen.
1772
Coding for Adequacy of Hemodialysis.
Carriers Manual Part 3--Claims Process (HCFA Pub. 14-3) (Superintendent
of Documents No. HE 22.8/7)
1624
Self-Administered Drugs and Biologicals.
1625
Identifying a Screening Mammography Claim.
1626
Requirements for Processing Electronic Media Claims.
1627
Requirements for Processing Electronic Media Claims.
1628
Payment for Oral Anti-Emetic Drugs When Used as Full
Replacement for Intravenous Anti-Emetic Drugs as Part of a Cancer
Chemotherapeutic Regimen.
1629
General Claims Processing Requirements.
1630
Type of Service.
Carriers Manual Part 4--Professional Relations (HCFA Pub. 14-4)
(Superintendent of Documents No. HE 22.8/7)
19
[[Page 68360]]
Registry of Physicians/Health Care Practitioners/Group
Practices.
Ongoing Data Collection on Physicians/Health Care Practitioners/
Group Practices Applications.
Physician/Health Care Practitioners/Group Practices Record-Required
Information and Format.
Maintaining Physician/Health Care and Practitioner/Group Practices
Memberships.
Update Records.
Batching Procedures.
Privacy Act Requirements.
Physician Opted Out.
Carrier Record Requirements.
Unique Physician Identification Number Carrier Record Layout.
20
Enrollment Instructions.
HCFA-855 R, Individual Reassignment of Benefits.
Enrolling Certified Providers/Suppliers Who Enroll with Carriers.
Program Memorandum Intermediaries (HCFA Pub. 60A) (Superintendent of
Documents No. HE 22.8/6-5)
A-99-1
Clarification of the Implementation of Sec. 510(a)(3) of
the Omnibus Consolidated and Emergency Supplemental Appropriation Act,
Fiscal Year 1999 Enacted on October 21, 1998 and the Wage Indices
Applicable to Guam and the Virgin Islands.
A-99-2
Hospital Outpatient Procedures: Billing for Contrast
Material (Clarification).
A-99-3
Hospital Outpatient Procedures: Medicare Changes for
Radiology and Other Diagnostic Coding Due to the 1998 HCFA Common
Procedures Coding System Update; Miscellaneous Changes.
A-99-4
Hepatitis C Virus Look Back.
A-99-5
Claims Processing Instructions for the National Institutes
of Health National Emphysema Treatment.
A-99-6
Information Requirements for Home Health Services--15
Minute Increment Reporting.
A-99-7
Extension of Due Date for Filing Provider Cost Reports.
A-99-8
Policy Clarification and Guidance for Services Furnished
by Rural Health Clinics and Federally Qualified Health Centers and
Announcement of Medicare Federally Qualified Health Centers and Rural
Health Clinics Payment Rate Increases.
A-99-9
Interim Rate Changes Due to the Elimination of the Formula
Driven Overpayment.
A-99-10
Rural Health Clinics and Federally Qualified Health
Centers Provisions Enacted by Sec. 4205 of the Balanced Budget Act of
1997.
A-99-11
Clarification of Provider Cost Report Filing Requirements.
A-99-12
Medicare Home Health Benefit--Sec. 4615 of the Balanced
Budget Act of 1997; Clarification That No Home Health Benefits are
Authorized Based Solely on Drawing Blood.
Program Memorandum Carriers (HCFA Pub. 60B) (Superintendent of
Documents No. HE 22.8/6-5)
B-99-1
Evaluating the Medical Necessity for Laboratory Panel
Current Procedural Terminology Codes.
B-99-2
Payment for Teleconsultations in Rural Health Professional
Shortage Areas.
B-99-3
Revisions to Transmittal No. AB-98-14 Dated April 1998
``Claims Processing Instructions for the National Institutes of Health
National Emphysema Treatment Trial.''
B-99-4
Standard System Acceptance of Primary Payer Information at
the Line Level.
B-99-5
Changes to the 1999 Medicare Physician Fee Schedule
Database.
B-99-6
Matrix to Complete Provider/Supplier Enrollment
Application (Form HCFA-855).
B-99-7
Millennium Changes for Forms HCFA-1491, 1490S, and 1490U.
B-99-8
Health Professional Shortage Area Bonus Payment
Clarification.
B-99-9
Change to Health Insurance Claim Form HCFA-1500
Instructions for Processing Physician Claims in Global Payment Systems.
B-99-10
Durable Medical Equipment Carrier Billing Procedures.
B-99-11
Modifications to Form HCFA-1500 Instructions.
B-99-12
Paramedic Intercept Provisions of the Balanced Budget Act
of 1997.
Program Memorandum Intermediaries/Carriers (HCFA Pub. 60A/B)
(Superintendent of Documents No. HE 22.8/6-5)
AB-99-1
Activating Y2K ``Return as Unprocessable'' Edits for Paper
and Electronic Media Claims.
AB-99-2
Updates to the Mammography Quality Standards Act Record
File Layout for Y2K Compliance.
AB-99-3
Ending Suppression of Explanation of Medicare Benefits and
Medicare Summary Notices for All Claim Types Except: Laboratory,
Demonstrations, Exact Duplicates, and Statistical Adjustments.
AB-99-4
Interim Claims Processing Instructions for Payment for
Oral Anti-Emetic Drugs When Used as Full Replacement for Intravenous
Anti-Emetic Drugs as Part of a Cancer Chemotherapeutic Regimen.
AB-99-5
Instructions for Implementing and Tracking the Medicare
Fraud and Abuse Incentive Reward Program.
AB-99-6
Notice of New Interest Rates for Medicare Overpayments and
Underpayments.
AB-99-7
Notification to Medicare Providers and Suppliers of
Beneficiary Right to an Itemized Statement.
AB-99-8
Provider Outreach Activities Specific to Y2K Awareness.
AB-99-9
Implementation of the Office of the Inspector General's
Fraud Hot Line Number on Medicare Beneficiary Notices.
AB-99-10
Provider Overpayment Recovery Physicians Supplier
Overpayment Recovery Systems Overpayments Transferred to the Debt
Collection Center for Cross Servicing.
AB-99-11
Consolidated Billing for Skilled Nursing Facilities.
Program Memorandum Medicaid State Agencies (HCFA Pub. 17)
(Superintendent of Documents No. HE 22.8/6-5)
99-1
Title XIX of the Social Security Act, Post-Eligibility
Treatment of Income.
[[Page 68361]]
State Operations Manual Provider Certification (HCFA Pub. 7)
(Superintendent of Documents No. HE 22.8/12)
5
Conducting Initial Surveys and Scheduled Resurveys.
Unannounced Surveys.
Survey Protocol for Long Term Care Facilities.
6
Sanctions for Intermediate Care Facilities/Mental
Retardation for Non-Immediate Jeopardy.
Directed Plan of Correction.
Directed In-Service Training.
State Monitoring.
Achieving Continuous Substantial Compliance.
Criteria for Review of State Plans for Approval or Disapproval of
Alternative Sanctions.
7
Survey Procedures and Interpretive Guidelines for
Laboratories and Laboratory Services.
Peer Review Organization Manual (HCFA Pub. 19) (Superintendent of
Documents No. HE 22.8/8-15)
69
Introduction.
HCFA/Office of Clinical Standards and Quality Requirements.
Statutory and Regulatory Requirements.
Definitions.
Office of Management and Budget Clearance.
Items Not Subject to Office of Management and Budget Clearance.
Request for Exception from Office of Management and Budget Review.
Survey Justification and Methods.
Additional Considerations.
Documentation for HCFA.
70
Introduction.
Anti-Dumping Violations.
Assistants at Cataract Surgery.
Beneficiary Complaints.
Hospital and Managed Care Plan Notices of Noncoverage.
Hospital-Requested Higher-Weighted Diagnostic Related Group
Assignments.
Potential Concerns Identified During Project Data Collection.
Referrals.
Quality Review.
Admission Review.
Invasive Procedure Review.
Length-of-Stay Review.
Coverage Review.
Diagnostic Related Group Validation Review.
Discharge Review.
Day and Cost Outlier Review.
Ambulatory Surgery Review.
Limitation on Liability Determinations.
Readmission Review.
Transfer Review.
Non-physician Review.
First Level Physician Review.
Action Following Opportunity for Discussion.
Second Level Physician Review.
Third Level Physician Review.
Use of the Physician Reviewer Assessment Format.
Review of Medicare Services.
Review Settings.
Using Screening Criteria.
Requesting Medical Records/Reviewing Documentation.
Providing Opportunity for Discussion.
Adhering to Review Time Frames.
Profiling Case Review Results.
Maintaining Memoranda of Agreements.
Monitoring an Important Message from Medicare.
Monitoring Hospitals' Physician Acknowledgment Statements.
Non-physician Reviewers.
Physician Reviews.
Health Care Practitioners Other Than Physicians.
Conflict of Interest.
Training.
71
Quality Review--Overview.
Determination of Source of Concerns.
Notification of Quality Concerns to Affected Parties.
Peer Review Organization Quality Improvement Activities.
Peer Review Organization Review Reporting Requirements.
Scope of Review.
Complaints That Do Not Meet Statutory Requirements.
Referrals.
Review Process.
Notice of Disclosure.
Disclosure of Quality Review Information to Complainants.
Data Analysis and Reporting Requirements.
Peer Review Organization Review Responsibilities.
Actions to be Taken by Peer Review Organizations.
Hospital Manual (HCFA Pub. 10) (Superintendent of Documents No. HE
22.8/2)
739
Identifying Other Primary Payers During the Admission
Process.
Admission Questions to Ask Medicare Beneficiaries.
740
Medicare Rural Hospital Flexibility Program.
Grandfathering Existing Facilities.
Requirements for Critical Access Hospital Services and Critical
Access Hospital Long-term Care Services.
Payment for Services Furnished by a Critical Access Hospital.
Payment for Post-Hospital Skilled Nursing Facilities Care.
Furnished by a Critical Access Hospital.
Review of Form HCFA-1450 for the Inpatient.
741
Coding for Adequacy of Hemodialysis.
Religious Nonmedical Health Care Institutions (Hospital Manual
Supplement) (HCFA Pub. 32) (Superintendent of Documents No. HE 22.8/2-
2)
41
Claims Processing Timeliness.
Home Health Agency Manual (HCFA Pub. 11) (Superintendent of Documents
No. HE 22.8/5)
290
Claims Processing Timeliness.
Skilled Nursing Facility Manual (HCFA Pub. 12) (Superintendent of
Documents No. HE 22.8/3)
358
Completion of Form HCFA-1450 for Inpatient and/or
Outpatient Billing.
Provider Electronic Billing File and Record Formats.
Alphabetic Listing of Data Elements.
359
Claims Processing Timeliness.
Rural Health Clinic and Federally Qualified Health Centers Manual (HCFA
Pub. 27) (Superintendent of Documents No. HE 22.8/19:985)
33
Claims Processing Timeliness.
Renal Dialysis Facility Manual (Non-Hospital Operated) (HCFA Pub. 29)
(Superintendent of Documents No. HE 22.8/13)
84
Completion of Form HCFA-1450 by Independent Facilities for
Home Dialysis Items and Services Billed Under the Composite Rate Method
I.
85
Claims Processing Timeliness.
86
Coding for Adequacy of Hemodialysis.
Hospice Manual (HCFA Pub. 21) (Superintendent of Documents No. HE 22.8/
18)
54
[[Page 68362]]
Claims Processing Timeliness.
Outpatient Physical Therapy, Comprehensive Outpatient Rehabilitation
Facility and Community Mental Health Center Manual (HCFA Pub. 9)
(Superintendent of Documents No. HE 22.8/9)
6
Claims Processing Timeliness.
Coverage Issues Manual (HCFA Pub. 6) (Superintendent of Documents No.
HE 22.8/14)
106
Positron Emission Tomography Scans.
107
Durable Medical Equipment Reference List.
108
Abortion.
Provider Reimbursement Manual--Part 1 (HCFA Pub. 15-1) (Superintendent
of Documents No. HE 22.8/4)
408
Travel Expense.
Effective Date of Change in Size of Participating Skilled Nursing
Facility.
Effective Date of Change in Size at Beginning of Cost Reporting
Quarter of Provider Following Approval by Regional Office.
Exceptions.
409
Effective Date of Change in Size of Participating Skilled
Nursing Facility.
Effective Date of Change in Size at Beginning of Cost Reporting
Quarter of Provider Following Approval by Regional Office Exceptions.
State Medicaid Manual Part 4--Services (HCFA Pub. 45-4) Superintendent
of Documents No. HE 22.8/10
72
Personal Care Services.
Medicare/Medicaid Sanction--Reinstatement Report (HCFA Pub. 69)
99-1
Report of Physicians/Practitioners, Providers and/or Other
Health Care Suppliers Excluded/Reinstated-December 1998.
99-2
Report of Physicians/Practitioners, Providers and/or Other
Health Care Suppliers Excluded/Reinstated-January 1999.
Addendum IV.--Regulation Documents Published in the Federal Register
----------------------------------------------------------------------------------------------------------------
End of
Publication FR Vol. 64 CFR* part(s) File code** Regulation title comment Effective
date page period date
----------------------------------------------------------------------------------------------------------------
01/04/99 69 Chapter IV...... HCFA-3250-N2..... Medicare Program; ........... ...........
Negotiated
Rulemaking;
Coverage and
Administrative
Policies for
Clinical Diagnostic
Laboratory Tests;
Announcement of
Additional Public
Meetings.
01/04/99 170-171 ................ HCFA-3889-N...... Medicare Program; ........... ...........
Open Town Hall
Meeting to Discuss
the Positron
Emission Tomography.
01/12/99 1784-1785 409, 410, 411, HCFA-1005-2N..... Medicare Program; 03/09/99 ...........
412, 413, 419, Prospective Payment
489, 498, and System for Hospital
1003. Outpatient
Services; Extension
Of Comment Period.
01/12/99 1785-1786 416 and 488..... HCFA-1885-4N..... Medicare Program; 03/09/99 ...........
Update of
Ratesetting
Methodology,
Payment Rates,
Payment Policies,
and the List of
Covered Procedures
for Ambulatory
Surgical Centers
Effective October
1, 1998; Extension
of Comment Period.
01/22/99 3474-3478 405............. HCFA-1002-NOI.... Medicare Program; 02/22/99 ...........
Ambulance Fee
Schedule; Intent to
Form Negotiated
Rulemaking
Committee.
01/25/99 3637-3650 409, 410, and HCFA-1813-FC..... Medicare Program; 03/26/99 02/24/99
424. Coverage of
Ambulance Services
and Vehicle and
Staff Requirements.
01/25/99 3748-3763 484 and 488..... HCFA-3006-IFC.... Medicare and 03/26/99 02/24/99
Medicaid Programs;
Reporting Outcome
and Assessment
Information Set
(OASIS) Data as
Part of the
Conditions of
Participation for
Home Health
Agencies.
01/25/99 3764-3784 484............. HCFA-3007-F...... Medicare and ........... 02/24/99
Medicaid Programs;
Comprehensive
Assessment and Use
of the OASIS as
Part of the
Conditions of
Participation for
Home Health
Agencies.
02/04/99 5667-5668 ................ HCFA-0001-N...... Medicare Program; ........... ...........
Year 2000 Readiness
Letter.
[[Page 68363]]
02/08/99 6102-6108 ................ HCFA-2014-N...... State Children's ........... ...........
Health Insurance
Program; Reserved
Allotments to
States for Fiscal
Year 1999 and
Revised Reserved
Allotments to
States for Fiscal
Year 1998.
02/11/99 6827-6852 410, 414, 424, HCFA-3002-P...... Medicare Program; 04/12/99 ...........
476, and 498. Expanded Coverage
for Outpatient
Diabetes Self-
Management Training
Services.
02/12/99 7198-7199 ................ HCFA-1064-N...... Medicare Program; ........... ...........
March 15, 1999,
Meeting of the
Practicing
Physicians Advisory
Council.
02/17/99 7968-7982 422............. HCFA-1030-F...... Medicare Program; ........... 03/19/99
Changes to the
Medicare+Choice
Program.
02/17/99 7899-7900 ................ HCFA-4008-N...... Medicare Program; ........... ...........
Establishment of
the Citizens
Advisory Panel on
Medicare Education
and Requests for
Nominations for
Members.
02/25/99 9378-9399 412............. HCFA-1049-F...... Medicare Program; ........... 03/01/99
Changes to the
Fiscal Year 1999
Hospital Inpatient
Prospective Payment
Wage Index and
Standardized
Amounts Resulting
From Approved
Requests for Wage
Data Revisions.
03/04/99 10479-10480 ................ HCFA-2041-N...... Medicaid Program; ........... 02/25/99
Decision on Funding
for the AIDS
Healthcare
Foundation START
Program.
03/11/99 12172-12173 ................ CFA-1068-N....... Medicare Program; ........... ...........
Meetings of the
Competitive Pricing
Demonstration Area
Advisory Committee,
Kansas City
Metropolitan Area.
03/11/99 12173 ................ HCFA-1101-N...... Medicare Program; ........... ...........
Meetings of the
Competitive Pricing
Demonstration Area
Advisory Committee,
Maricopa County, AZ.
03/12/99 12277-12278 409, 410, 411, HCFA-1005-3N..... Medicare Program; 06/30/99 ...........
412, 413, 419, Prospective Payment
489, 498, and System for Hospital
1003. Outpatient
Services; Extension
of Comment Period.
03/12/99 12278-12279 416 and 488..... HCFA-1885-5N..... Medicare Program; 06/30/99 ...........
Update of
Ratesetting
Methodology,
Payment Rates,
Payment Policies
and the List of
Covered Procedures
for Ambulatory
Surgical Centers
Effective October
1, 1998; Extension
of Comment Period.
03/12/99 12404 ................ HCFA-2014-N...... State Children's ........... ...........
Health Insurance
Program; Reserved
Allotments to
States for Fiscal
Year 1999 and
Revised Reserved
Allotments to
States for Fiscal
Year 1998.
03/18/99 13354-13362 488............. HCFA-2035-FC..... Medicare and 05/17/99 05/17/99
Medicaid Programs;
Civil Money
Penalties for
Nursing Homes (SNF/
NF), Change in
Notice
Requirements, and
Expansion of
Discretionary
Remedy Delegation.
03/23/99 13998-13999 ................ HCFA-1100-N...... Medicare Program; 06/21/99 ...........
Medicare
Coordinated Care
Demonstration
Project and Request
for Information on
Potential Best
Practices of
Coordinated Care.
[[Page 68364]]
03/26/99 14666 405............. HCFA-1002-N...... Medicare Program; ........... ...........
Meetings of the
Negotiated
Rulemaking
Committee on
Ambulance Fee
Schedule.
03/29/99 14931-14934 ................ HCFA-2032-N...... Medicare Program; ........... 10/01/98
State Allotments
for Payment of
Medicare Part B
Premiums for
Qualifying
Individuals:
Federal Fiscal Year
1999.
----------------------------------------------------------------------------------------------------------------
* 42 CFR except where noted.
** N--General Notice; PN--Proposed Notice; NC--Notice with Comment Period; FN--Final Notice; P--Notice of
Proposed Rulemaking (NPRM); F--Final Rule; FC--Final Rule with Comment Period; CN--Correction Notice; IFC--
Interim Final Rule with Comment Period; GNC--General Notice with Comment Period.
Addendum V--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 HCFA, the Food and Drug Administration assigns
each device with a Food and Drug Administration-approved
investigational device exemption to one of two categories. 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, category
(in this case, A), and criterion code.
G980173 A2
G980257 A1
G980263 A1
G980315 A1
G980320 A1
G980330 A2
G990028 A1
G990037 A1
G990043 A2
G990053 A1
The following information presents the device number, category
(in this case, B), and criterion code.
G980095 B4
G980139 B4
G980143 B2
G980188 B4
G980243 B4
G980254 B4
G980273 B4
G980281 B3
G980307 B4
G980308 B4
G980310 B
G980312 B3
G980313 B4
G980314 B4
G980318 B2
G980319 B4
G980321 B4
G980322 B
G980323 B2
G980324 B4
G980326 B2
G980328 B3
G990004 B4
G990005 B1
G990006 B4
G990010 B4
G990011 B3
G990014 B3
G990016 B5
G990019 B4
G990020 B4
G990022 B2
G990023 B4
G990024 B3
G990026 B2
G990029 B4
G990031 B3
G990035 B1
G990036 B2
G990041 B4
G990042 B4
G990044 B1
G990046 B4
G990050 B2
G990051 B4
[FR Doc. 99-31601 Filed 12-6-99; 8:45 am]
BILLING CODE 4120-01-P