Medicare and Medicaid Programs; Quarterly Listing of Program Issuances and Coverage DecisionsFourth Quarter 1994
Federal RegisterApr 6, 1995
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPO-130-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances and Coverage Decisions--Fourth Quarter 1994
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice lists HCFA manual instructions, substantive and
interpretive regulations and other Federal Register notices, and
statements of policy that were published during October, November, and
December of 1994 that relate to the Medicare and Medicaid programs.
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. We are also
providing the content of revisions to the Medicare Coverage Issues
Manual published between October 1 and December 31, 1994. On August 21,
1989, we published the content of the Manual (54 FR 34555) and
indicated that we will publish [[Page 17539]] quarterly any updates.
Adding to this listing the complete text of the changes to the Medicare
Coverage Issues Manual allows us to fulfill this requirement in a
manner that facilitates identification of coverage and other changes in
our manuals.
FOR FURTHER INFORMATION CONTACT: Margaret Cotton, (410) 966-5255 (For
Medicare instruction information); Pat Prete, (410) 966-3246 (For
Medicaid instruction information); Michael Robinson, (410) 966-5633
(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 who process claims and pay bills,
and others. To implement the various statutes on which the programs are
based, we issue regulations under 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, statements of policy, 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 timeframe. 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 are listing in this notice Medicaid issuances and
Medicaid substantive and interpretive regulations published from
October 1 through December 31, 1994.
II. Medicare Coverage Issues
We receive numerous inquiries from the general public about whether
specific items or services are covered under Medicare. Providers,
carriers, and intermediaries have copies of the Medicare Coverage
Issues Manual, which identifies those medical items, services,
technologies, or treatment procedures that can be paid for under
Medicare. On August 21, 1989, we published a notice in the Federal
Register (54 FR 34555) that contained all the Medicare coverage
decisions issued in that manual.
In that notice, we indicated that revisions to the Coverage Issues
Manual will be published at least quarterly in the Federal Register. We
also sometimes issue proposed or final national coverage decision
changes in separate Federal Register notices. Readers should find this
an easy way to identify both issuance changes to all our manuals and
the text of changes to the Coverage Issues Manual.
Revisions to the Coverage Issues Manual are not published on a
regular basis but on an as-needed basis. We publish revisions as a
result of technological changes, medical practice changes, responses to
inquiries we receive seeking clarifications, or the resolution of
coverage issues under Medicare. If no Coverage Issues Manual revisions
were published during a particular quarter, our listing will reflect
that fact.
Not all revisions to the Coverage Issues Manual contain major
changes. As with any instruction, sometimes minor clarifications or
revisions are made within the text. We have reprinted manual revisions
as transmitted to manual holders. The new text is shown in italics. We
will not reprint the table of contents, since the table of contents
serves primarily as a finding aid for the user of the manual and does
not identify items as covered or not.
III. 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 coverage decisions 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 identifies updates that changed
the Coverage Issues Manual. We published notices in the Federal
Register that included the text of changes to the Coverage Issues
Manual. These updates, when added to material from the manual published
on August 21, 1989 constitute a complete manual as of December 31,
1994. Parties interested in obtaining a copy of the manual and
revisions should follow the instructions in section IV of this notice.
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 sets forth the revisions to the Medicare Coverage
Issues Manual that were published during the quarter covered by this
notice. For the revisions, we give a brief synopsis of the revisions as
they appear on the transmittal sheet, the manual section number, and
the title of the section. We present a complete copy of the revised
material, no matter how minor the revision, and identify the revisions
by printing in italics the text that was changed. If the transmittal
includes material unrelated to the revised section, for example, when
the addition of revised material causes other sections to be
repaginated, we do not reprint the unrelated material.
Addendum V 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 title of
the regulation, the parts of the Code of Federal Regulations (CFR)
which have changed (if applicable), the agency file code number, the
ending date of the comment period (if applicable), and the effective
date (if applicable). [[Page 17540]]
IV. 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
Order, 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.
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
indicated above. When ordering individual copies, it is necessary to
cite either the date of publication or the volume number and page
number.
C. Rulings
Rulings are published on an infrequent basis by HCFA. Interested
individuals can obtain copies from the nearest HCFA Regional Office or
review them at the nearest regional depository library. We also
sometimes publish Rulings in the Federal Register.
D. HCFA's Compact Disk-Read Only Memory (CD-ROM)
HCFA's laws, regulations, and manuals are now 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 contained 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, 1993. The remaining portions of CD-ROM are
updated on a monthly basis.
The CD-ROM disk does not contain Appendix M (Interpretative
Guidelines for Hospices). Copies of this appendix may be reviewed at a
Federal Depository Library (FDL).
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.
V. How to Review Listed Material
Transmittals or Program Memoranda can be reviewed at a local 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, individuals should
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 Carriers Manual, Part 2--
Program Administration (HCFA-Pub. 14-2) transmittal entitled ``Files
Maintenance Program General'', use the Superintendent of Documents No.
HE 22.8/6-2 and the HCFA transmittal number 127.
VI. 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 Addenda III may be addressed
to Margaret Cotton, Issuances Staff, Bureau of Program Operations,
Health Care Financing Administration, Room 688 East High Rise, 6325
Security Blvd., Baltimore, MD 21207, Telephone (410) 966-5255.
Questions concerning Medicaid items in Addenda III may be addressed
to Pat Prete, Medicaid Bureau, Office of Medicaid Policy, Health Care
Financing Administration, Room 233 East High Rise, 6325 Security Blvd.,
Baltimore, MD 21207, Telephone (410) 966-3246.
Questions concerning all other information may be addressed to
Michael Robinson, Office of Regulations, Health Care Financing
Administration, Room 132 East High Rise, 6325 Security Blvd.,
Baltimore, MD 21207, Telephone (410) 966-5633.
(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: March 23, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Addendum I
This addendum lists the publication dates of the most recent
quarterly listing of program issuances and coverage decision updates to
the Coverage Issues Manual. For a complete listing, please refer to the
listing in the January 3, 1995 quarterly notice (60 FR 132).
March 17, 1994 (59 FR 12610)
August 5, 1994 (59 FR 40038)
November 14, 1994 (59 FR 56501)
January 3, 1995 (60 FR 132)
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.
[[Page 17541]]
Addendum III.--Medicare and Medicaid Manual Instructions
[October Through December 1994]
------------------------------------------------------------------------
Trans. No. Manual/Subject/Publication Number
------------------------------------------------------------------------
Intermediary Manual
Part 2--Audits, Reimbursement
Program Administration (HCFA-Pub. 13-2)
(Superintendent of Documents No. HE 22.8/6-1)
------------------------------------------------------------------------
400 <bull Files Maintenance Program--General.
e
Records Retention and Disposal Schedule.
Retention of Claims Files Materials.
Microfilming of Files Material.
Intermediary--Federal Records Center Relations.
Location of Federal Records Centers.
Procedures for Transfer of Material to Federal
Records Centers.
Requesting Forms for Transfer and Return of
Material from Federal Records Centers.
Report of Medicare Records--Form HCFA-2556.
Exhibits.
401 <bull Location of Federal Records Centers.
e
------------------------------------------------------------------------
Intermediary Manual
Part 3--Claims Process (HCFA-13-3)
(Superintendent of Documents No. HE 22.8/6)
------------------------------------------------------------------------
1636 <bull Responsibility for Medicare Secondary Payer
e Outreach Program.
Quarterly Supplement to Intermediary Workload
Report (Form HCFA-1566A) General.
Completing Quarterly Supplement to the Intermediary
Workload Report, HCFA-1566A, Pages 1 and 2.
Completing Quarterly Supplement to the Intermediary
Workload Report, HCFA-1566A, Page 3.
Completing Quarterly Periodic Interim Payment
Report, HCFA-1566C--General.
1637 <bull Reporting Outpatient Surgery and Other Services.
e
PPS Pricer Program.
Provider-Specific Data Record Layout and
Description.
1638 <bull Mammography Screening.
e
Mammography Quality Standards Act.
1639 <bull Disallowance Form Letters HCFA-1954 and HCFA-1955.
e
Explanation of Medicare Benefits Notice
Specifications.
1640 <bull General Effect of Liability Insurance on Medicare
e Payment.
Appeals Procedures for MSP Liability Overpayments.
1641 <bull Mammography Screening.
e
------------------------------------------------------------------------
Carriers Manual
Part 2--Program Administration (HCFA-14-2)
(Superintendent of Documents No. HE 22.8/6-2)
------------------------------------------------------------------------
127 <bull Files Maintenance Program--General.
e
Records Retention and Disposal Schedule.
Retention of Claims Files Materials.
Microfilming of Files Materials.
Report of Medicare Records--Form HCFA-2556.
Location of Federal Records Centers.
Procedures for Transfer of Material to Federal
Records Centers.
Requesting Forms for Transfer and Return of
Material from Federal Records Centers.
Exhibits.
128 <bull Location of Federal Records Centers.
e
------------------------------------------------------------------------
Carriers Manual
Part 4--Professional Relations (HCFA-Pub. 14-4)
(Superintendent of Documents No. HE 22.8/7-4)
------------------------------------------------------------------------
9 <bull Responsibility in the Medicare Secondary Payer
e Outreach Program.
10 <bull National Registry of Physicians/Health Care
e Practitioners/Group Practices-Medicare Provider
Identifier (UPIN).
Ongoing Data Collection On Physicians/Health Care
Practitioners/Group Applications.
Physicians/Health Care Practitioners/Group
Practices Record-Required Information and Format.
Maintaining Physicians/Health Care Practitioner/
Group Practice Membership.
Validation of Physicians/Health Care Practitioners/
Group Practices Credentials, Certifications,
Sanction and License Information for Prior
Practice.
<bull UPIN Cross Referral Requirement.
e
Maintenance of The Registry.
Update Records.
Rejections.
Exceptions.
Carrier Record Requirements.
UPIN Carrier Record Layout.
[[Page 17542]]
List of Medical School Codes.
------------------------------------------------------------------------
Carriers Manual
Part 3--Claims Process (HCFA-Pub. 14-3)
(Superintendent of Documents No. HE 22.8/7)
------------------------------------------------------------------------
1501 <bull Quarterly Supplements to the Carrier Performance
e Report (Forms HCFA-1565A, HCFA-1565B, HCFA-1565C,
and HCFA-1565D)--General.
Completing Form HCFA-1565A.
Completion of Items on Form HCFA-1565A.
Completing Medicare Fraud Unit Quarterly Workload
Status Report, HCFA-1565B--General.
Completing Form HCFA-1565C.
Completion of Items on Form HCFA-1565C.
Completing Comprehensive Limiting Charge Compliance
Program Quarterly Report HCFA-1565D--General.
Completing Medicare Fraud Unit Quarterly Status
Report, Form HCFA-1565B.
Completing Carrier Limiting Charge Compliance
Program Quarterly Report, Form HCFA-1565D.
1502 <bull Chiropractors.
e
Manual Manipulation.
Verification of Chiropractor's Qualifications.
1503 <bull Part B Provider Access to Limited Eligibility Data.
e
Eligibility Data Available.
Contractor Implementation.
Data Format.
Part B Eligibility Data Security Requirements.
HCFA Standard Part B Eligibility Data Security
Requirements.
HCFA Standard Part B Eligibility Inquiry Flat File
Specifications.
HCFA Standard Part B Eligibility Response Flat File
Specifications.
1504 <bull Type of Service.
e
1505 <bull Self-Administering of Drug or Biological.
e
1506 <bull List of Covered Surgical Procedures.
e
1507 <bull Rebundling of CPT-4 Codes.
e
------------------------------------------------------------------------
Program Memorandum
Intermediaries (HCFA-Pub. 60A)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
A-94-8 <bull Revised Wages Indexes for Ambulatory Surgical
e Centers--Pricer for 7.0 and 8.0.
A-94-9 <bull FY 1995 Prospective Payment System and Other Bill
e Processing Changes.
A-94-10 <bull Ambulatory Surgical Center--Pricer 9.0.
e
------------------------------------------------------------------------
Program Memorandum
Carriers (HCFA-Pub. 60B)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
B-94-6 <bull 1995 Physician, Practitioner and Supplier
e Participation Enrollment and Fee Schedule
Disclosure.
B-94-7 <bull 1995 Physician, Practitioner and Supplier
e Participation Enrollment and Fee Schedule
Disclosure.
B-94-8 <bull Split Billing for Professional and Technical
e Components of Services.
------------------------------------------------------------------------
Program Memorandum
Intermediaries/Carriers (HCFA-Pub. 60AB)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
AB-94-8 <bull Revised Codes for Part B Ground Ambulance Services.
e
------------------------------------------------------------------------
Program Memorandum
Medicaid State Agencies (HCFA-Pub. 17)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
94-8 <bull Title XIX, Social Security Act, Vaccines for
e Children Program.
94-9 <bull Title XIX, Social Security Act, Personal Care
e Services Provided in a Home or Other Location.
------------------------------------------------------------------------
Regional Office Manual
Standards and Certification (HCFA-Pub. 23-4)
(Superintendent of Documents No. HE 22.28/5:90-1)
------------------------------------------------------------------------
55 <bull Developing the Budget Approval.
e
Submittal of Budget Approval.
Distribution of Approved Funds.
Disbursement of Authorized Funds.
[[Page 17543]]
The Budget Call.
Monitoring State Agency Fiscal Budgets.
56 <bull Approval Procedures for Hospitals in the 50-99 Bed
e Category.
------------------------------------------------------------------------
Peer Review Organization Manual
(HCFA-Pub. 19)
(Superintendent of Documents No. HE 22.8/15)
------------------------------------------------------------------------
40 <bull Introduction.
e
MOA with State Agencies Responsible for Licensing/
Certification of Providers/Practitioners.
Model Memorandum of Agreement.
41 <bull Complaints to be Reviewed.
e
Disposition of Complaints.
Disclosing Information.
Monitoring Hospital-Issued Notices of Noncoverage.
Beneficiary Liability.
Model Hospital-Issued Notice of Noncoverage
Continued Stay--Swing Bed Only.
42 <bull DRG Validation Review.
e
43 <bull Training.
e
------------------------------------------------------------------------
Hospital Manual
(HCFA-Pub. 10)
(Superintendent of Documents No. HE 22.8/2)
------------------------------------------------------------------------
673 <bull Billing for Mammography Screening.
e
Mammography Quality Standards Act.
674 <bull Billing for Mammography Screening.
e
------------------------------------------------------------------------
Skilled Nursing Facility
(HCFA-Pub. 12)
(Superintendent of Documents No. HE 22.8/3)
------------------------------------------------------------------------
332 <bull Billing for Mammography Screening.
e
Mammography Quality Standards Act.
333 <bull Billing for Mammography Screening.
e
------------------------------------------------------------------------
State Medicaid Manual
Part 3--Eligibility (HCFA-Pub. 45-3)
(Superintendent of Documents No. HE 22.8/10)
------------------------------------------------------------------------
64 <bull Transfers of Assets for Less Than Fair Market
e Value.
Treatment of Trusts.
------------------------------------------------------------------------
State Medicaid Manual
Part 6--Payment for Services (HCFA-Pub. 45-6)
(Superintendent of Documents No. HE 22.8/10)
------------------------------------------------------------------------
26 <bull Listing of Multiple Source Drugs.
e
------------------------------------------------------------------------
State Medicaid Manual
Part 7--Quality Control (HCFA-Pub. 45-7)
(Superintendent of Documents No. HE 22.8/10)
------------------------------------------------------------------------
52 <bull Computations of Financial Eligibility.
e
Verification Guide--Coverage Code 02 for OASDI
Recipients.
Verification Guide--Coverage Code 01 or 03.
Verification Guide--Coverage Code 18 for QDWI
Individuals.
Verification Guide--Coverage Code 25 for
Individuals Whose Eligibility for Medicaid Has
Otherwise Ceased.
Verification Guide--Coverage Code 26 for
Individuals Whose Eligibility for Medicaid Has
Otherwise Ceased.
Verification Guide--Coverage Code 29 for
Individuals Receiving Home and Community-Based
Services and Other Waiver Services.
Verification Guide--Coverage Code 31.
Verification Guide--Coverage Code 40 for AFDC
Families.
------------------------------------------------------------------------
Coverage Issues Manual
(HCFA-Pub. 6)
(Superintendent of Documents No. HE 22.8/14)
------------------------------------------------------------------------
72 <bull Blood Transfusions.
e
[[Page 17544]]
73 <bull Hydrophilic Contact Lens for Corneal Bandage.
e
------------------------------------------------------------------------
Home Health Agency Manual
(HCFA-Pub. 11)
(Superintendent of Documents No. HE 22.8/5)
------------------------------------------------------------------------
273 <bull Home Health Certification and Plan of Care.
e
------------------------------------------------------------------------
State Operations Manual
Provider Certification (HCFA-Pub. 7)
(Superintendent of Documents No. HE 22.8/12)
------------------------------------------------------------------------
265 <bull Hospice Regulations and Non-Medicare Patients.
e
Operation of a Hospice Across State Lines.
Compliance with Advance Directives.
Hospice--Citations and Description.
Hospice Multiple Locations.
Election of Hospice Benefit by Resident of a
Skilled Nursing Facility, Nursing Facility,
Intermediate Care Facility for the Mentally
Retarded, or Non-Certified Facility.
Hospice Inpatient Services Furnished Directly or
Furnished Under Arrangements.
Hospice Home Visit Procedures.
Model Consent for Hospice Home Visit Form.
Hospice Survey and Deficiencies Report.
Interpretive Guidelines--Hospices.
------------------------------------------------------------------------
Rural Health Clinic and Federally
Qualified Health Centers Manual (HCFA-Pub. 27)
(Superintendent of Documents No. HE 22.8/19:985)
------------------------------------------------------------------------
16 <bull Billing for Mammography Screening by Rural Health
e Clinic and Federally Qualified Health Centers.
Mammography Qualified Standards Act.
17 <bull Billing for Mammography Screening by Rural Health
e Clinics and Federally Qualified Health Centers.
------------------------------------------------------------------------
Medicare/Medicaid
Sanction--Reinstatement Report
------------------------------------------------------------------------
94-13 <bull Report of Physician/Practitioners, Providers and/or
e Other Health Care Suppliers Excluded/Reinstated.
94-14 <bull Report of Physician/Practitioners, Providers and/or
e Other Health Care Suppliers Excluded/Reinstated.
------------------------------------------------------------------------
Addendum IV--Medicare Coverage Issues Manual
(For the reader's convenience, new material and changes to previously
published material are in italics. If any part of a sentence in the
manual instruction has changed, the entire line is shown in italics.
The transmittal includes material unrelated to revised sections. We are
not reprinting the unrelated material.)
Transmittal No. 72; section 45-27 Blood Transfusions NEW
INPLEMENTING INSTRUCTIONS--EFFECTIVE DATE: For services performed on or
after 12-08-94.
Section 45-27, Blood Transfusions.--This section has been added to
clarify the coverage and payment policies for blood transfusions.
45-27 BLOOD TRANSFUSIONS
Blood transfusions are used to restore blood volume after
hemorrhage, to improve the oxygen carrying capacity of blood in severe
anemia, and to combat shock in acute hemolytic anemia.
A. Definitions.--
1. Homologous Blood Transfusion.--Homologous blood transfusion is
the infusion of blood or blood components that have been collected from
the general public.
2. Autologous Blood Transfusion.--An autologous blood transfusion
is the precollection and subsequent infusion of a patient's own blood.
3. Donor Directed Blood Transfusion.--A donor directed blood
transfusion is the infusion of blood or blood components that have been
precollected from a specific individual(s) other than the patient and
subsequently infused into the specific patient for whom the blood is
designated. For example, patient B's brother predeposits his blood for
use by patient B during upcoming surgery.
4. Perioperative Blood Salvage.--Perioperative blood salvage is the
collection and reinfusion of blood lost during and immediately after
surgery.
B. Policy Governing Transfusions.--For Medicare coverage purposes,
it is important to distinguish between a transfusion itself and
preoperative blood services; e.g., collection, processing, storage.
Medically necessary transfusion of blood, regardless of the type, may
generally be a covered service under both Part A and Part B of
Medicare. Coverage does not make a distinction between the transfusion
of homologous, autologous, or donor-directed blood. With respect to the
coverage of the services associated with the preoperative collection,
processing, and storage of autologous and donor-directed blood, the
following policies apply.
1. Hospital Part A and B Coverage and Payment.--Under
Sec. 1862(a)(14) of the Act, nonphysician services furnished to
hospital patients are covered and paid for as hospital services. The
inclusion of services [[Page 17545]] provided to hospital patients by
an outside supplier as part of hospital services is referred to as
``bundling.'' In a situation where a hospital obtains either autologous
or donor-directed blood from an independent supplier, the supplier
collects, processes, and stores the blood and, typically, delivers it
to the hospital. The hospital is responsible for paying the supplier.
Part A payment, as specified in Sec. 1814(b) of the Act, and Part B
payment, as specified in Sec. 1833(a) of the Act, relate to reasonable
cost as defined in Sec. 1861(v) of the Act. Under this system, when a
hospital obtains autologous or donor-directed blood from an independent
blood bank, Medicare recognizes only a processing fee charged to the
hospital by the independent blood bank because the blood has been
replaced, albeit in advance. The processing fee is recorded by the
hospital in the blood storing, processing, and transfusion cost center.
This cost center also includes any costs the hospital itself incurs to
process and administer the blood after it has been procured. This
includes the cost of such activities as storing, type crossmatching,
and transfusing the blood, as well as the cost of spoiled or defective
blood. The hospital may generate a charge for these costs (except for
spoiled or defective blood) and, under cost reimbursement, Medicare
picks up its share of the costs through cost apportionment. As provided
in Sec. 1886 of the Act, under the prospective payment system (PPS),
the diagnosis related group (DRG) payment to the hospital includes all
covered blood and blood processing expenses, whether or not the blood
is eventually used.
In a situation where the hospital operates its own blood collection
activities, rather than using an independent blood supplier, the costs
incurred to collect autologous or donor-directed blood are recorded in
the whole blood and packed red blood cells cost center. Because the
blood has been replaced, Medicare does not recognize a charge for the
blood itself. Therefore, under cost reimbursement, these costs are
shared by all patients through cost apportionment. The costs incurred
by the hospital to store, process, and transfuse the blood, as well as
the cost of spoiled or defective blood, are recorded in the blood
storing, processing, and transfusion cost center. The hospital may
generate a charge for these costs (except for the cost of spoiled or
defective blood) and, under cost reimbursement, Medicare picks up its
share of these costs through cost apportionment. Under PPS, the DRG
payment is intended to pay for all covered blood and blood services,
whether or not the blood is eventually used.
Under its provider agreement, a hospital is required to furnish or
arrange for all covered services furnished to hospital patients.
Medicare payment is made to the hospital, under PPS or cost
reimbursement, for covered inpatient and outpatient services, and it is
intended to reflect payment for all costs of furnishing those services.
2. Nonhospital Part B Coverage.--Under Part B, to be eligible for
separate coverage, a service must fit the definition of one of the
services authorized by Sec. 1832 of the Act. These services are defined
in 42 CFR 410.10 and do not include a separate category for a
supplier's services associated with blood donation services, either
autologous or donor-directed. That is, the collection, processing, and
storage of blood for later transfusion into the beneficiary is not
recognized as a separate service under Part B. Therefore, there is no
avenue through which a blood supplier can receive direct payment under
Part B for blood donation services.
C. Perioperative Blood Salvage.--When the perioperative blood
salvage process is used in surgery on a hospital patient, payment made
to the hospital (under PPS or through cost reimbursement) for the
procedure in which that process is used is intended to encompass
payment for all costs relating to that process.
Transmittal No. 73; Section 45-7, Hydrophilic Contact Lens for
Corneal Bandage. CLARIFICATION--EFFECTIVE DATE: Not Applicable.
Section 45-7, Hydrophilic Contact Lens for Corneal Bandage.--This
section has been revised to explain how payment is provided for
hydrophilic contact lenses when they are furnished incident to a
physician's services. Payment for the lenses is bundled into the
payment for the physician service to which it is incident. If the
lenses are covered as other than incident to a physician's service,
they are not paid under the physicians' fee schedule and would be
covered prosthetic devices, which follow other payment provisions of
the Act.
45-7 HYDROPHILIC CONTACT LENS FOR CORNEAL BANDAGE
Some hydrophilic contact lenses are used as moist corneal bandages
for the treatment of acute or chronic corneal pathology, such as
bullous keratopathy, dry eyes, corneal ulcers and erosion, keratitis,
corneal edema, descemetocele, corneal ectasis, Mooren's ulcer, anterior
corneal dystrophy, neurotrophic keratoconjunctivitis, and for other
therapeutic reasons.
Payment may be made under Sec. 1861(s)(2) of the Act for a
hydrophilic contact lens approved by the Food and Drug Administration
(FDA) and used as a supply incident to a physician's service. Payment
for the lens is included in the payment for the physician's service to
which the lens is incident. Contractors are authorized to accept an FDA
letter of approval or other FDA published material as evidence of FDA
approval. (See Sec. 65-1 for coverage of a hydrophilic contact lens as
a prosthetic device.) See Intermediary Manual, Sec. 3112.4 and Carriers
Manual, Secs. 2050.1 and 15010.
Addendum V.--Regulation Documents Published in the Federal Register
--------------------------------------------------------------------------------------------------------------------------------------------------------
End of
Publication date FR page numbers CFR part File code* Regulation title comment Effective
period date
--------------------------------------------------------------------------------------------------------------------------------------------------------
10/03/94............ 50235-50240 ................ MB-084-NC Medicaid Program; Charges for Vaccine ........... 10/01/94
Administration Under the Vaccines for
Children (VFC) Program.
10/03/94............ 50246-50253 ................ ORD-068-N Medicare and Medicaid Programs; Small ........... 10/03/94
Business Innovation Research Grants for
Fiscal Year 1995.
10/07/94............ 51125-51130 403 OBS-001-FC Medicare Program; Information, Counseling, 12/06/94 10/07/94
and Assistance Grants Program.
[[Page 17546]]
10/13/94............ 51989 ................ MB-084-CN Medicaid Program; Charges for Vaccine 12/12/94 10/01/94
Administration Under the Vaccines for
Children (VFC) Program Correction.
10/14/94............ 52129-52132 418 BPD-820-N Hospice Services Under Medicare Program; 11/14/94 10/14/94
Intent To Form Negotiated Rulemaking
Committee.
10/19/94............ 52862 488 489 BPD-393-IFC Medicare Program; Participation in CHAMPUS 08/22/94 07/22/94
and CHAMPVA, Hospital Admissions for
Veterans, Discharge Rights Notice, and
Hospital Responsibility for Emergency
Care OFR Correction.
10/20/94............ 52968-52971 ................ HSQ-220-N CLIA Program; Approval of the American ........... 10/20/94
Society for Histocompatibility and
Immunogenetics for the Specialty of
Histocompatibility.
10/20/94............ 52971-52972 ................ OPL-002-N Medicare Program; Request for Nominations ........... 10/20/94
for Members for the Practicing Physicians
Advisory Council.
10/21/94............ 53187-53193 ................ BPO-124-PN Medicare Program; Data, Standards, and 12/20/94 ...........
Methodology Used to Establish Fiscal Year
1995 Budgets for Fiscal Intermediaries
and Carriers.
11/10/94............ 56116-56252 401 431 435 HSQ-156-F Medicare and Medicaid Programs, Survey, ........... 07/01/95
440 441 442 Certification and Enforcement of Skilled
447 483 488 Nursing Facilities and Nursing Facilities.
489 498
11/14/94............ 56501-56510 ................ BPO-127-N Medicare and Medicaid Programs; Quarterly ........... 11/14/94
Listing of Program Issuances and Covered
Decisions-Second Quarter 1994.
11/16/94............ 59241-61629 ................ BPO-128-N Medicare and Medicaid Programs; Delay in ........... 11/16/94
Implementation of the Medicare-Medicaid
Coverage Data Bank Requirements.
11/17/94............ 59624 ................ MB-060-P Medicaid Program; Inpatient Psychiatric 01/17/94 ...........
Services for Individuals Under Age 21.
11/21/94............ 59933-59943 417 OMC-008-F Medicare Program; Appeal Rights and ........... 12/21/94
Procedures for Beneficiaries Enrolled in
Prepaid Health Care Plans.
11/22/94............ 60109-60156 205 MB-092-P Aid to Families With Dependent Children; 01/23/95 ...........
National Voter Registration Act of 1993;
Implementation.
11/23/94............ 60365 ................ OPL-003-N Medicare Program; Meeting of the ........... 11/23/94
Practicing Physicians Advisory Council.
12/01/94............ 61629-61628 ................ OACT-046-N Medicare Program; Part A Premium for 1995 ........... 01/01/95
for the Uninsured Aged and for Certain
Disabled Individuals Who Have Exhausted
Other Entitlement.
12/01/94............ 61629-61633 ................ OACT-047-N Medicare Program; Monthly Actuarial Rates ........... 01/01/95
and Monthly Supplementary Medical
Insurance Premium Rates Beginning January
1, 1995.
12/01/94............ 61628-61633 ................ OACT-048-N Medicare Program; Inpatient Hospital ........... 01/01/95
Deductible and Hospital and Extended Care
Services Coinsurance Amounts for 1995.
[[Page 17547]]
12/06/94............ 62606-62609 493 HSQ-217-FC Medicare, Medicaid and CLIA Programs; 02/06/95 12/06/94
Extension of Certain Effective Dates for
Clinical Laboratory Requirements and
Personnel Requirements for Cytologists.
12/08/94............ 63410-63635 410 414 BPD-789-FC Medicare Program; Refinements to 02/06/95 01/01/95
Geographic Adjustment Factor Values,
Revisions to Payment Policies,
Adjustments to the Relative Value Units
(RVUs) Under The Physician Fee Schedule
for Calender Year 1995, and the 5-Year
Refinement of RVUs.
12/08/94............ 63638-63646 ................ BPD-807-FN Physician Fee Schedule Update for Calendar ........... 01/01/95
Year 1995 and Physician Volume
Performance Standard Rates of Increase
for Federal Fiscal Year 1995.
12/13/94............ 64141-64153 405 482 BPD-421-F Medicare and Medicaid Programs; Revisions ........... 01/12/95
to Conditions of Participation for
Hospitals.
12/13/94............ 64153-64156 412 413 BPD-802-CN Medicare Program; Changes to the Hospital ........... 10/01/94
Inpatient Prospective Systems and Fiscal
Year 1995 Rates; Correction.
12/20/94............ 64482-65498 409 413 418 BPD-469-F Medicare Program; Medicare Coverage of ........... 02/21/95
484 Home Health Services, Medicare Conditions
of Participation, and Home Health Aide
Supervision.
12/23/94............ 66314-66316 ................ HSQ-221-N Medicare, Medicaid, and CLIA Programs; ........... 12/29/94
Clinical Laboratory Improvement
Amendments of 1988 Continuance of
Exemption of Laboratories Licensed by the
State of Washington.
12/29/94............ 67264-67265 ................ BPD-822-N Medicare Program; Hospice Wage Index...... ........... 12/29/94
12/29/94............ 67265 ................ BPD-823-N Medicare Program; Hospice Wage Index...... ........... 12/29/94
--------------------------------------------------------------------------------------------------------------------------------------------------------
*GN--General Notice; PN--Proposed Notice; FN--Final Notice; P--Notice of Proposed Rulemaking (NPRM); F--Final Rule; FC--Final Rule with Comment Period;
CN--Correction Notice; SN--Suspension Notice; WN--Withdrawal Notice; NR--Notice of HCFA Ruling.
[FR Doc. 95-8398 Filed 4-5-95; 8:45 am]
BILLING CODE 4120-01-P
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.