[Federal Register Volume 63, Number 107 (Thursday, June 4, 1998)]
[Notices]
[Pages 30499-30506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14834]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HCFA-9152-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--Third Quarter 1997
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 July, August, and September of 1997 that relate to the
Medicare and Medicaid programs. It also identifies certain devices with
investigational device exemption numbers approved by the Food and Drug
Administration that may be potentially 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 including all Medicaid issuances
and Medicare and Medicaid substantive and interpretive regulations
(proposed and final) published during this timeframe.
FOR FURTHER INFORMATION CONTACT:
Bridget Wilhite, (410) 786-5248 (For Medicare instruction information).
Betty Stanton, (410) 786-3247 (For Medicaid instruction information).
Sharon Hippler, (410) 786-4633 (For Food and Drug Administration-
approved investigational device exemption information).
Pamela Gulliver, (410) 786-4659 (For all other information).
SUPPLEMENTARY INFORMATION:
I. Program Issuances
The Health Care Financing Administration (HCFA) is responsible for
administering the Medicare and Medicaid programs, which pay for health
care and related services for 38 million Medicare beneficiaries and 36
million Medicaid recipients. Administration of these programs involves
(1) providing 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 the Secretary
under sections 1102, 1871, and 1902 and related provisions of the
Social Security Act (the Act) and also issue various manuals,
memoranda, and statements necessary to administer the programs
efficiently.
Section 1871(c)(1) of the Act requires that we publish in the
Federal Register at least every 3 months a list of all Medicare manual
instructions, interpretive rules, and guidelines of general
applicability not issued as regulations. 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. Since the publication of our quarterly
listing on June 12, 1992 (57 FR 24797), we decided to add Medicaid
issuances to our quarterly listings. Accordingly, we list in this
notice Medicaid issuances and Medicaid substantive and interpretive
regulations published during July through September 1997.
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. Most notably, 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) and the
notice published March 31, 1993 (58 FR 16837), and 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 of this notice lists, for each of our manuals or
Program Memoranda, a HCFA transmittal number unique to that instruction
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, the Federal Register citation, the parts of
the Code of Federal Regulations (CFR) that have changed (if
applicable), the agency file code number, the title of the regulation,
the ending date of the comment period (if applicable), and the
effective date (if applicable).
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 and certain services related to those devices
may be covered under Medicare. It is HCFA's practice to announce in
this quarterly notice all investigational device exemption
categorizations, using the investigational device exemption numbers the
Food and Drug Administration assigns. 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
[[Page 30500]]
this notice. 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
An individual or organization interested in routinely receiving any
manual and revisions to it may purchase a subscription to that manual.
Those wishing to subscribe 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).
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. In addition, 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,
which 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. 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 1400 designated libraries
throughout the United States. Interested parties may examine the
documents at any one of the FDLs. Some may have arrangements to
transfer material to a local library not designated as an FDL. To
locate the nearest FDL, contact any library.
In addition, individuals may contact regional depository libraries,
which 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
instruction, use the Superintendent of Documents number, plus the HCFA
transmittal number. For example, to find the Home Health Agency Manual,
(HCFA Pub. 11) transmittal entitled ``Billing for Durable Medical
Equipment, Orthotic/Prosthetic Devices,'' use the Superintendent of
Documents No. HE 22.8/5 and the HCFA transmittal number 283.
V. General Information
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. Copies can be purchased or reviewed as
noted above.
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, Telephone (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, C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244-
1850, Telephone (410) 786-3247.
Questions concerning Food and Drug Administration-approved
investigational device exemptions may be addressed to Sharon Hippler,
Office of Clinical Standards and Quality, Coverage Analysis Group,
Health Care Financing Administration, C4-11-04, 7500 Security
Boulevard, Baltimore, MD 21244-1850, Telephone (410) 786-4633.
Questions concerning all other information may be addressed to
Pamela Gulliver, Office of Communications and
[[Page 30501]]
Operations Support, Division of Regulations and Issuances, Health Care
Financing Administration, C5-09-26, 7500 Security Boulevard, Baltimore,
MD 21244-1850, Telephone (410) 786-4659.
(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: May 5, 1998.
Pamela J. Gentry,
Director, Office of Communications and Operations Support.
Addendum I
This addendum lists the publication dates of the most recent
quarterly listings of program issuances.
December 18, 1996 (61 FR 66676)
April 21, 1997 (62 FR 19328)
May 12, 1997 (62 FR 25957)
November 3, 1997 (62 FR 59358)
November 21, 1997 (62 FR 62325)
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, at 57 FR 47468.
Addendum III--Medicare and Medicaid Manual Instructions July 1997
Through September 1997
------------------------------------------------------------------------
Trans. Manual/Subject/Publication No,
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Intermediary Manual
Part 1--Fiscal Administration
(HCFA Pub. 13-1)
(Superintendent of Documents No. HE 22.8/6-3)
------------------------------------------------------------------------
128......................... Coordination of Medicare and
Complementary Insurance Programs.
Coordination of Medicare With the Federal
Grants in Aid Program (Medicaid).
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Intermediary Manual
Part 3--Claims Process
(HCFA Pub. 13-3)
(Superintendent of Documents No. HE 22.8/6)
------------------------------------------------------------------------
1715........................ Self-Administered Drug
Administered In An Emergency Situation.
1716........................ Mammography Screening.
1717........................ HCPCS for Hospital Outpatient
Radiology Services and Other Diagnostic
Procedures.
1718........................ Billing for Durable Medical
Equipment, Orthotic/Prosthetic Devices
and Surgical Dressings.
1719........................ CFA Common Procedure Coding
System.
1720........................ Completing Quarterly Report on
Provider Enrollment.
1721........................ Laboratory Tests for
Hemodialysis, Intermittent Peritoneal
Dialysis, Continuous Cycling Peritoneal
Dialysis and Hemofiltration.
Laboratory Tests.
1722........................ HCPCS Codes for Diagnostic
Services and Medical Services (Correction
to Transmittal Number 1719, dated July
1997).
1723........................ Claims Processing Timeliness.
1724........................ HCPCS Codes for Diagnostic
Services and Medical Services--Correction
to Transmittal Number 1722, Dated August
1997.
1725........................ Mammography Screening.
Focused Medical Review.
Focused Medical Review Activity Report.
1726........................ Review of Form HCFA-1450 for
Inpatient and Outpatient Bills.
Provider Electronic Billing File and
Record Formats.
Alphabetic Listing of Data Elements.
------------------------------------------------------------------------
Intermediary Manual.
Part 4--Audit Procedures
(HCFA Pub. 13-4)
(Superintendent of Documents No. HE 22.8/6-4)
------------------------------------------------------------------------
33.......................... Home Office Uniform Desk Review.
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Carriers Manual
Part 1--Fiscal Administration (HCFA Pub. 14-1)
(Superintendent of Documents No. HE 22.8/7-2)
------------------------------------------------------------------------
122......................... Coordination of Medicare and
Complementary Insurance Programs.
Coordination of Medicare With the
Federal Grants in Aid Program (Medicaid).
------------------------------------------------------------------------
Carriers Manual
Part 2--Claims Process (HCFA Pub. 14-2)
(Superintendent of Documents No. HE 22.8/7-3)
------------------------------------------------------------------------
136......................... Functional Standards for Claims
Processing Operations.
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[[Page 30502]]
Carriers Manual
Part 3--Claims Process
(HCFA Pub. 14-3)
(Superintendent of Documents No. HE 22.8/7)
------------------------------------------------------------------------
1573........................ Evidence of Medical Necessity for
Durable Medical Equipment.
General Claims Processing Requirements.
Billing Requirements.
Simplified Roster Bills.
Health Insurance Maintenance Organization
Processing Requirements.
Speciality Code/Place of Service
Processing Requirements.
Suppression of EOMBs.
Billing Requirements for Global Surgeries.
Claims Review for Global Surgeries.
Payment for Return Trips to the Operating
Room for Treatment of Complications.
EOMB and Remittance Messages.
Payment for Eyeglasses, Contact Lenses,
and Related Services.
Interpretation of Diagnostic Tests.
1574........................ Identifying a Screening
Mammography Claim.
1575........................ Claims Processing Terminology.
Handling Incomplete or Invalid Claims.
Conditional Data Element Requirements.
Data Element Requirements Matrix.
Data Element Requirements.
Incomplete or Invalid Claims.
1576........................ Exception to Sec. 7560 A and B
When Physician, Other Practitioner, or
Supplier Is Excluded From Participation
in Medicare Program.
Authority to Exclude Practitioners,
Providers, and Suppliers of Services.
1577........................ Evidence of Medicaid Necessity
for Durable Medical Equipment (Correction
to Transmittal Number 1573, dated July
1997).
1578........................ Assistant at Surgery Services.
Purchased Diagnostic Tests.
Inpatient Dialysis On Same Date As
Evaluation and Management.
Consultations.
Threshold Times For Codes 99354 and 99355.
1579........................ Services Eligible for HPSA Bonus
Payments.
Remittance Messages.
1580........................ Doctor of Medicine and
Osteopathy.
------------------------------------------------------------------------
Carriers Manual
Part 4--Professional Relations
(HCFA Pub. 14-4)
(Superintendent of Documents No. HE 22.8/7-4)
------------------------------------------------------------------------
14.......................... Patient and Insured Information.
Provider of Service or Supplier
Information.
Place of Service Codes and Definitions.
------------------------------------------------------------------------
Program Memorandum
Intermediaries (HCFA Pub. 60A)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
A-97-5...................... Application of Medicare
Reasonable Cost Reimbursement Principles
to Rural Health Clinics.
A-97-6...................... Extension of Due Date for Filing
Form HCFA-2540-96 and Form HCFA-1728-94
Cost Reports.
A-97-7...................... Home Health Agency Requests to
Intermediaries to Change Cost Center
Allocation Sequence or Statistical
Allocation Basis.
A-97-8...................... Instructions to Implement the New
Medicare Summary Notice.
A-97-9...................... Hospital Outpatient Procedures:
Medicare Changes Due to 1997 HCPCS
Update--New Dermatology Codes
(Clarification).
A-97-10..................... Change in Hospice Payment Rates.
A-97-11..................... Hospice Provisions Enacted by the
Balanced Budget Act of 1997.
A-97-12..................... Medicare Home Health Benefit--The
Balanced Budget Act of 1997 Clarification
of Part-Time or Intermittent Skilled
Nursing Care.
A-97-13..................... FY 1998 Prospective Payment
System, TEFRA Hospital and Other Bill
Processing Changes.
A-97-14..................... Hospital Outpatient Procedures:
Billing for Contrast Material
(Clarification).
------------------------------------------------------------------------
Program Memorandum
Carriers
(HCFA Pub. 60B)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
B-97-2...................... Changes to Correct Coding Edits,
Version 4.0.
B-97-3...................... Instructions for CLIA Compliance
for Part B Laboratory Claims Submitted to
Carriers.
B-97-4...................... Instructions for CLIA Compliance
for Part B Laboratory Claims Submitted to
Carriers-- Correction to Transmittal
Number B-97-3, dated September 1997.
B-97-5...................... Update of Rates and Wage Index
for Ambulatory Surgical Center Payments
Effective October 1, 1997.
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[[Page 30503]]
Program Memorandum
Intermediaries/Carriers
(HCFA Pub. 60A/B)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
AB-97-10.................... Claims for Separately Billable
End Stage Renal Disease Laboratory
Services Performed by Certified
Independent Dialysis Facilities.
AB-97-11.................... Counting of Non-Medicare Home
Health Visits and the Reporting of the
Associated Costs in Determining the
Average Cost Per Visit for Home Health
Services.
AB-97-12.................... New Implementation Date for
Hematocrit Levels for Erythropoietin.
AB-97-13.................... Extension of the Limitation on
Payment for Services to Individuals
Entitled to Benefits on the Basis of End
Stage Renal Disease Who are Covered by
Group Health Plans.
AB-97-14.................... Extension of the Limitation on
Payment for Services to Individuals
Entitled to Benefits on the Basis of End
Stage Renal Disease Who are Covered by
Group Health Plans (GHP)-- Correction to
Program Memorandum Number AB-97-13, dated
September 1997.
AB-97-15.................... Update to the Hospice Wage Index.
AB-97-16.................... Balanced Budget Act of 1997, P.L.
105-33 (H.R. 2015)--Home Health Payment
Provisions.
AB-97-17.................... New Panels Approved by Common
Procedural Terminology--Clarification of
Program Memorandum AB-97-5.
AB-97-18.................... Balanced Budget Act of 1997, P.L.
105-33 (H.R.)-Home Health Payment
Provisions.
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State Operations Manual
Provider Certification
(HCFA Pub. 7)
(Superintendent of Documents No. HE 22.8/12)
------------------------------------------------------------------------
283......................... Interpretive Guidelines and
Survey Procedures.
------------------------------------------------------------------------
Peer Review Organization Manual
(HCFA Pub. 19)
(Superintendent of Documents No. HE 22.8/8-15)
------------------------------------------------------------------------
64.......................... Opportunity to Discuss.
Authority.
Scope of Review.
Complaints That Do Not Meet Statutory
Requirements.
Referrals.
Review Process.
------------------------------------------------------------------------
Hospital Manual
(HCFA Pub. 10)
(Superintendent of Documents No. HE 22.8/2)
------------------------------------------------------------------------
716......................... Self-Administered Drug
Administered In An Emergency Situation.
717......................... Billing for Mammography
Screening.
718......................... HCPCS for Hospital Outpatient
Radiology Services and Other Diagnostic
Procedures.
719......................... Billing for Durable Medical
Equipment, Orthotic/Prosthetic Devices,
and Surgical Dressings.
720......................... HCFA Common Procedure Coding
System.
721......................... HCPCS Codes for Diagnostic
Services and Medical Services.
722......................... Billing for Mammography
Screening.
------------------------------------------------------------------------
Home Health Agency Manual
(HCFA Pub. 11)
(Superintendent of Documents No. HE 22.8/5)
------------------------------------------------------------------------
283......................... Billing for Durable Medical
Equipment, Orthotic/Prosthetic Devices.
------------------------------------------------------------------------
Skilled Nursing Facility Manual
(HCFA Pub. 12)
(Superintendent of Documents No. HE 22.8/3)
------------------------------------------------------------------------
348......................... Billing for Mammography
Screening.
349......................... Billing for Durable Medical
Equipment (DME), Orthotic/Prosthetic
Devices, and Surgical Dressings.
350......................... Billing for Mammography
Screening.
------------------------------------------------------------------------
Outpatient Physical Therapy and Comprehensive Outpatient Rehabilitation
Facility Manual
(HCFA Pub. 9)
(Superintendent of Documents No. HE 22.8/9)
------------------------------------------------------------------------
130......................... Billing for Durable Medical
Equipment Orthotic/Prosthetic Devices,
and Surgical Dressings.
------------------------------------------------------------------------
Coverage Issues Manual
(HCFA Pub. 6)
(Superintendent of Documents No. HE 22.8/18)
------------------------------------------------------------------------
102......................... Hyperbaric Oxygen Therapy
[[Page 30504]]
Lung Volume Reduction Surgery (Reduction
Pneumoplasty, Also Called Lung Shaving or
Lung Contouring) Unilateral or Bilateral
by Open or Thoracoscopic Approach for
Treatment of Emphysema or Chronic
Obstructive Pulmonary Disease.
------------------------------------------------------------------------
Provider Reimbursement Manual--Part 1
(HCFA Pub. 15-1)
(Superintendent of Documents No. 22.8/4)
------------------------------------------------------------------------
400......................... Provider Requests Regarding
Applicability of Cost Limits.
Request for Exemption From Skilled Nursing
Facility Cost Limits.
------------------------------------------------------------------------
Provider Reimbursement Manual--Part I
Chapter 27--Reimbursement for ESRD and Transplant Services
(HCFA Pub. 15-1-27)
(Superintendent of Documents No. 22.8/4)
------------------------------------------------------------------------
29.......................... Allowable Compensation for
Physician Owners and Medical Directors
Allowable Compensation for Owners,
Administrators, and Assistant
Administrators.
Submission of Documentation.
------------------------------------------------------------------------
Provider Reimbursement Manual--Part II
Provider Cost Reporting Forms and Instructions
(HCFA Pub. 15-II-A)
(Superintendent of Documents No. 22.8/4)
------------------------------------------------------------------------
19.......................... Electronic Submission of Cost
Reports.
Electronic Submission of Hospital Cost
Reports.
Electronic Submission of SNF and HHA Cost
Reports.
Provider Reimbursement Manual--Part II
Provider Cost Reporting Forms and Instructions
(HCFA Pub. 15-II-A)
(Superintendent of Documents No. 22.8/4)
------------------------------------------------------------------------
3........................... Hospital and Hospital Health Care
Complex Cost Report, Form HCFA-2552-96.
------------------------------------------------------------------------
State Medicaid Manual--Part 2
State Organization and General Administration
(HCFA Pub. 45-2)
(Superintendent of Documents No. HE22.8/10)
------------------------------------------------------------------------
89.......................... Statistical Report on Medical
Care: Eligibles, Recipients, Payments,
and Services (Form HCFA-2082).
Requirements for State Participation in
the Medicaid Statistical Information
System.
------------------------------------------------------------------------
State Medicaid Manual--Part 3
Eligibility
(HCFA Pub. 45-3)
(Superintendent of Documents No. HE22.8/10)
------------------------------------------------------------------------
68.......................... Retroactive Medicaid Coverage.
------------------------------------------------------------------------
State Medicaid Manual--Part 6
Payment for Services
(HCFA Pub. 45-6)
(Superintendent of Documents No. HE22.8/10)
------------------------------------------------------------------------
34.......................... Ingredient Prices Used by States
to Establish Upper Limits for
Prescription Drugs.
------------------------------------------------------------------------
Rural Health Clinic Manual and Federally
Qualified Health Centers Manual
(HCFA Pub. 27)
(Superintendent of Documents No. HE22.8/19:985)
------------------------------------------------------------------------
27.......................... Billing for Mammography Screening
by Rural Health Clinics and Federally
Qualified Health Centers.
28.......................... Billing for Mammography Screening
by Rural Health Clinics and Federally
Qualified Health Centers.
------------------------------------------------------------------------
Program Memorandum
State Survey Agencies
(HCFA Pub. 65)
------------------------------------------------------------------------
97-1........................ Policy Clarification: Home Health
Agency Parent, Branch, and Subunit
Criteria.
------------------------------------------------------------------------
Medicare/Medicaid
Sanction--Reinstatement Report
(HCFA Pub. 69)
------------------------------------------------------------------------
97-7........................ Report of Physicians/
Practitioners, Providers and/or Other
Health Care Suppliers Excluded/
Reinstated--May 1997.
[[Page 30505]]
97-8........................ Report of Physicians/
Practitioners, Providers and/or Other
Health Care Suppliers Excluded/
Reinstated--June 1997.
97-9........................ Report of Physicians/
Practitioners, Providers and/or Other
Health Care Suppliers Excluded/
Reinstated--July 1997.
97-10....................... Report of Physicians/
Practitioners, Providers and/or Other
Health Care Suppliers Excluded/
Reinstated--August 1997.
------------------------------------------------------------------------
Addendum IV.--Regulation Documents Published in the Federal Register
----------------------------------------------------------------------------------------------------------------
End of
Publication date FR Vol. 62, CFR part(s) File code* Regulation title comment Effective
page period date
----------------------------------------------------------------------------------------------------------------
07/01/97........ 35513-35516 ........... HSQ-243-N........... Medicare, Medicaid, ........... 07/01/97
and CLIA Programs;
Clinical Laboratory
Improvement
Amendments of 1988
Continuance of
Exemption of
Laboratories
Licensed by the
State of Washington.
07/01/97........ 35608-35634 ........... BPD-889-NC.......... Medicare Program; 09/02/97 07/01/97
Schedule of Limits
on Home Health
Agency Costs Per
Visit for Cost
Reporting Periods
Beginning on or
After July 1, 1997.
07/02/97........ 35824-35826 ........... HSQ-207-NC.......... Medicare Program; 09/02/97 07/02/97
Description of the
Health Care
Financing
Administration's
Evaluation
Methodology for the
Peer Review
Organization 5th
Scope of Work
Contracts.
07/16/97........ 38100-38107 ........... BPD-845-PN.......... Medicare Program; 09/15/97 07/16/97
Special Payment
Limits for Home
Oxygen.
07/17/97........ 38314-38315 ........... ORD-101-N........... New and Pending ........... 07/17/97
Demonstration
Project Proposals
Submitted Pursuant
to Section 1115(a)
of the Social
Security Act: May
1997.
07/29/97........ 40568 ........... BPD-889-NC.......... Medicare Program; ........... 07/01/97
Schedule of Limits
on Home Health
Agency Costs Per
Visit for Cost
Reporting Periods
Beginning on or
After July 1, 1997;
CORRECTION.
08/08/97........ 42860-42883 418 BPD-820-F........... Medicare Program; ........... 10/01/97
Hospice Wage Index.
08/14/97........ 43541-43542 ........... ORD-102-N........... New and Pending ........... 08/14/97
Demonstration
Project Proposals
Submitted Pursuant
to Section 1115(a)
of the Social
Security Act: June
1997.
08/15/97........ 43657-43674 412 413 414 BPD-763-F........... Medicare Program; ........... 08/15/97
End-Stage Renal
Disease (ESRD)
Payment Exception
Requests and Organ
Procurement Costs.
08/18/97........ 43962-43963 400 405 410 BPD-884-CN.......... Medicare Program; ........... ...........
414 Revisions to
Payment Policies
Under the Physician
Fee Schedule, Other
Part B Payment
Policies, and
Establishment of
the Clinical
Psychologist Fee
Schedule for
Calendar Year 1998;
CORRECTION.
08/18/97........ 43931-43937 431 442 488 HSQ-139-F........... Medicare and ........... 09/17/97
489 498 Medicaid Programs;
Effective Dates of
Provider Agreements
and Supplier
Approvals.
08/20/97........ 44221 488 HSQ-156-CN.......... Medicare and ........... 07/01/95
Medicaid Programs;
Survey,
Certification and
Enforcement of
Skilled Nursing
Facilities and
Nursing Facilities.
08/29/97........ 45815-45821 ........... HSQ-219-GNC......... CLIA Program; Fee 10/28/97 01/01/98
Schedule Revision.
08/29/97........ 45823 ........... OPL-016-N........... Medicare Program; ........... ...........
September 22, 1997,
Meeting of the
Practicing
Physician Ad visory
Council.
08/29/97........ 45966-46140 400 409 410 BPD-878-FC.......... Medicare Program; 10/28/97 10/01/97
411 412 413 Changes to the
424 440 485 Hospital Inpatient
488 489 498 Prospective Payment
Systems and Fiscal
Year 1998 Rates.
09/04/97........ 46698-46707 416 BPD-831-P........... Medicare Program; 11/03/97 09/04/97
Adjustment in
Payment Amounts for
New Technology
Intraocular Lenses.
09/08/97........ 47237 416 BPD-878-FC.......... Medicare Program;
Changes to the
Hospital Inpatient
Prospective Payment
Systems and Fiscal
Year 1998 Rates;
CORRECTION.
09/11/97........ 47896-47903 440 MB-071-F............ Medicaid Program; ........... 11/10/97
Coverage of
Personal Care
Services.
09/12/97........ 48098-48105 ........... MB-115-N............ State Children's ........... ...........
Health Insurance
Program; Reserved
Allotments to
States for Fiscal
Year 1998; Enhanced
Federal Medical
Assistance
Percentages.
09/15/97........ 48292-48297 ........... MB-110-N............ Medicaid Program; ........... ...........
Final Limitations
on Aggregate
Payments to
Disproportionate
Share Hospitals:
Federal Fiscal Year
1997.
[[Page 30506]]
09/17/97........ 48872-48873 ........... BPD-898-NC.......... Medicare and 11/17/97 ...........
Medicaid Programs;
Announcement of
Additional
Applications From
Hospitals
Requesting Waivers
for Organ
Procurement Service
Area.
09/18/97........ 49049 400 409 410 BPD-878-FC.......... Medicare Program; ........... ...........
411 412 413 Changes to the
424 440 485 Hospital Inpatient
488 489 498 Prospective Payment
Systems and Fiscal
Year 1998 Rates;
CORRECTION.
09/23/97........ 49649-49654 ........... OMC-029-N........... Medicare Program; 10/08/97 ...........
Solvency Standards
for Provider-
Sponsored
Organizations;
Intent To Form
Negotiated
Rulemaking
Committee.
09/23/97........ 49726 440 MB-071-F............ Medicaid Program; ........... ...........
Coverage of
Personal Care
Services;
CORRECTION.
09/24/97........ 49937-49938 473 BPD-453-CN.......... Medicare Program; ........... 06/11/97
Medicare Appeals of
Individual Claims;
CORRECTION.
----------------------------------------------------------------------------------------------------------------
Categorization of Food and Drug Administration-Approved 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.
G960082 A1
G970008 A4
G970044 A2
G970058 A2
G970069 A2
G970073 A2
G970088 A2
G970118 A2
G970121 A2
G970128 A1
G970131 A1
G970136 A2
G970147 A1
G970151 A2
G970169 A2
G970176 A2
The following information presents the device number, category (in
this case, B), and criterion code.
G910187 B1
G960161 B4
G970014 B2
G970015 B4
G970024 B4
G970045 B4
G970081 B4
G970094 B3
G970096 B1
G970112 B2
G970116 B1
G970117 B4
G970122 B4
G970123 B4
G970129 B2
G970132 B3
G970133 B3
G970134 B4
G970135 B4
G970137 B4
G970138 B4
G970140 B1
G970141 B2
G970142 B1
G970149 B3
G970150 B1
G970157 B4
G970161 B4
G970168 B1
G970178 B2
G970179 B2
G970180 B4
G970183 B1
G970189 B4
G970191 B1
G970193 B2
G970194 B2
[FR Doc. 98-14834 Filed 6-3-98; 8:45 am]
BILLING CODE 4120-01-P