[Federal Register Volume 59, Number 150 (Friday, August 5, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19111]


[[Page Unknown]]

[Federal Register: August 5, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[BPO-126-N]

 

Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances and Coverage Decisions--First Quarter 1994

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, and 
statements of policy that were published during January, February, and 
March 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 January 1, and March 31, 1994. 
On August 21, 1989 (54 FR 34555), we published the content of the 
Manual and indicated that we will publish 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) 966-5260 (For Medicare instruction information)
Walter Rutemueller, (410) 966-5395 (For Medicare coverage 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 36 million Medicare beneficiaries and 33 
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 
January 1 through March 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 March 17, 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 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).
    Addendum V 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.

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) 783-
3238, 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 the September 1, 1992. The remaining portions of CD-ROM 
are updated on a monthly basis.
    The CD-ROM disk does not contain Appendices M (Interpretative 
Guidelines for Hospices) and R (Resident Assessment for Long Term Care 
Facilities) of the State Operations Manual. Copies of these appendices 
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 3--Claims Process (HCFA-Pub. 14-3) 
transmittal entitled ``Claims Involving Patients Who Have Elected 
Hospice Care,'' use the Superintendent of Documents No. HE 22.8/7, and 
the HCFA transmittal number 1475.

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, Office of Issuances, Health Care Financing 
Administration, Room 688 East High Rise, 6325 Security Blvd., 
Baltimore, MD 21207, Telephone (410) 966-5260.
    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 items in Addenda V may be addressed to Walter 
Rutemueller, Office of Coverage and Eligibility Policy, Health Care 
Financing Administration, Room 401 East High Rise, 6325 Security Blvd., 
Baltimore, MD 21207, Telephone (410) 966-5395.
    Questions concerning all other information may be addressed to 
Michael Robinson, Regulations Staff, 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: June 30, 1994.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.

Addendum I

    This addendum lists the publication dates of the quarterly listing 
of program issuances and coverage decision updates to the Coverage 
Issues Manual.

March 20, 1990 (55 FR 10290)
February 6, 1991 (56 FR 4830)
July 5, 1991 (56 FR 30752)
November 22, 1991 (56 FR 58913)
January 22, 1992 (57 FR 2558)
March 16, 1992 (57 FR 9127)
June 11, 1992 (57 FR 24797)
October 16, 1992 (57 FR 47468)
January 7, 1993 (58 FR 3028)
March 31, 1993 (58 FR 16837)
July 9, 1993 (58 FR 36967)
September 1, 1993 (58 FR 46200)
December 22, 1993 (58 FR 67796)
March 17, 1994 (59 FR 12610)

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        
                      [January Through March 1994]                      
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Trans. No.                  Manual/Subject/Publication Number           
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                           Intermediary Manual                          
                  Part 2--Audits, Reimbursement Program                 
                     Administration (HCFA-Pub. 13-2)                    
              (Superintendent of Documents No. HE 22.8/6-2)             
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396          As indicated by at least a 6-week trial, the patient 
cannot be maintained on noninvasive methods of spasm control, such as 
oral anti-spasmodic drugs, either because these methods fail to control 
adequately the spasticity or produce intolerable side effects, and
     Prior to pump implantation, the patient must have 
responded favorably to a trial intrathecal dose of the anti-spasmodic 
drug.
    3. Opioid Drugs for Treatment of Chronic Intractable Pain.--An 
implantable infusion pump is covered when used to administer opioid 
drugs (e.g., morphine) intrathecally or epidurally for treatment of 
severe chronic intractable pain of malignant or nonmalignant origin in 
patients who have a life expectancy of at least 3 months and who have 
proven unresponsive to less invasive medical therapy as determined by 
the following criteria:
     The patient's history must indicate that he/she would not 
respond adequately to non-invasive methods of pain control, such as 
systemic opioids (including attempts to eliminate physical and 
behavioral abnormalities which may cause an exaggerated reaction to 
pain); and
     A preliminary trial of intraspinal opioid drug 
administration must be undertaken with a temporary intrathecal/epidural 
catheter to substantiate adequately acceptable pain relief and degree 
of side effects (including effects on the activities of daily living) 
and patient acceptance.
    4. Coverage of Other Uses of Implanted Infusion Pumps.--
Determinations may be made on coverage of other uses of implanted 
infusion pumps if the contractor's medical staff verifies that:
     The drug is reasonable and necessary for the treatment of 
the individual patient;
     It is medically necessary that the drug be administered by 
an implanted infusion pump; and
     The FDA approved labelling for the pump must specify that 
the drug being administered and the purpose for which it is 
administered is an indicated use for the pump.
    5. Implantation of Infusion Pump Is Contraindicated.--The 
implantation of an infusion pump is contraindicated in the following 
patients:
     Patients with a known allergy or hypersensitivity to the 
drug being used (e.g., oral baclofen, morphine, etc.);
     Patients who have an infection;
     Patients whose body size is insufficient to support the 
weight and bulk of the device; and
     Patients with other implanted programmable devices since 
crosstalk between devices may inadvertently change the prescription.

    Note: Payment may also be made for drugs necessary for the 
effective use of an implantable infusion pump as long as the drug 
being used with the pump is itself reasonable and necessary for the 
patient's treatment.

    The following indications for treatment using infusion pumps are 
not covered under medicare:
    A. External Infusion Pumps.--
    1. Diabetes (Effective for Services Performed On or After 1/29/
85).--The use of an external infusion pump for the subcutaneous 
infusion of insulin in the treatment of diabetes is not covered.
    B. Implantable Infusion Pump.--
    1. Thromboembolic Disease (Effective for Services Performed On or 
After 9/26/84).--According to the Public Health Service, there is 
insufficient published clinical data to support the safety and 
effectiveness of the heparin implantable pump. Therefore, the use of an 
implantable infusion pump for infusion of heparin in the treatment of 
recurrent thromboembolic disease is not covered.
    Transmittal No. 68. Section 50-32. CHANGED IMPLEMENTATION 
Instructions--Effective Date: For Services Performed on or After 03/17/
94.
    Section 50-32, Percutaneous Transluminal Angioplasty (PTA), is 
revised to provide for additional coverage of this procedure. PTA 
coverage is expanded to include treatment of atherosclerotic 
obstructions of vessels in the upper extremities. The upper extremities 
do not include head or neck vessels. Clarification is made that PTA is 
covered in the treatment of obstructive lesions of the arteriovenous 
dialysis fistulas through either an arterial or a venos approach.
50-32  Percutaneous Transluminal Angioplasty (PTA)
    This procedure involves inserting a balloon catheter into a narrow 
or occluded blood vessel to recanalize and dilate the vessel by 
inflating the balloon. PTA is covered to treat the following 
indications:
     Atherosclerotic obstructive lesions:
    - In the lower extremities, i.e., the iliac, femoral, and popliteal 
arteries, or in the upper extremities, i.e., the innominate, 
subclavian, axillary, and brachial arteries. The upper extremities do 
not include head or neck vessels.
    - Of a single coronary artery for patients for whom the likely 
alternative treatment is coronary bypass surgery and who exhibit the 
following characteristics:
     Angina refractory to optimal medical management;
     Objective evidence of myocardial ischemia; and
     Lesions amenable to angioplasty;
    - Of the renal arteries for patients in whom there is an inadequate 
response to a thorough medical management of symptoms and for whom 
surgery is the likely alternative. PTA for this group of patients is an 
alternative to surgery, not simply an addition to medical management.
     Obstructive lesions of arteriovenous dialysis fistulas and 
grafts when performed through either a venous or arterial approach.
    PTA is not covered to treat obstructive lesions of the carotid, 
vertebral and cerebral arteries. The safety and efficacy of these 
procedures have not been established.
    Transmittal No. 69. Section 50-13. Changed Implementing 
Instructions--Effective Date: Services performed on or after 03/22/94.
    Section 50-13, Magnetic Resonance Imaging, provides for coverage of 
magnetic resonance imaging (MRI) to diagnose disc disease without 
regard to whether radiologic imaging has been tried first to diagnose 
the problem.
50-13  Magnetic Resonance Imaging (Effective for services performed on 
or after 11-22-85.)
    Magnetic resonance imaging (MRI), formerly called nuclear magnetic 
resonance (NMR), is covered under Medicare when furnished as described 
below for the types of covered conditions described in this 
instruction.
    A. General
    1. Method of Operation.--Magnetic resonance imaging is a 
noninvasive method of graphically representing the distribution of 
water and other hydrogen-rich molecules in the human body. In contrast 
to conventional radiographs or CT scans, in which the image is produced 
by X-ray beam attenuation by an object, MRI is capable of producing 
images by several techniques. In fact, various combinations of MR image 
production methods may be employed to emphasize particular 
characteristics of the tissue or body part being examined. The basic 
elements by which MRI produces an image are the density of hydrogen 
nuclei in the object examined, their motion, and the relaxation times, 
the period of time required for the nuclei to return to their original 
states in the main, static magnetic field after being subjected to a 
brief additional magnetic field. These relaxation times reflect the 
physical-chemical properties of tissue and the molecular environment of 
its hydrogen nuclei. Only hydrogren atoms are present in human tissues 
in sufficient concentration for current use in clinical MRI.
    2. General Clinical Utility.--Overall, MRI is a useful diagnostic 
imaging modality that is capable of demonstrating a wide variety of 
soft-tissue lesions with contrast resolution equal or superior to CT 
scanning in various parts of the body.
    Among the advantages of MRI are the absence of ionizing radiation 
and the ability to achieve high levels of tissue contrast resolution 
without injected iodinated radiological contrast agents. Recent 
advances in technology have resulted in development and FDA approval of 
new paramagnetic contrast agents for MRI which allow even better 
visualization in some instances. Multislice imaging and the ability to 
image in multiple planes, especially sagittal and coronal, have 
provided a flexibility not easily available with other modalities. 
Because cortical (outer layer) bone and metallic prostheses do not 
cause distortion of MR images, it has been possible to visualize 
certain lesions and body regions with greater certainty than has been 
possible with CT. The use of MRI on certain soft tissue structures for 
the purpose of detecting disruptive, neoplastic, degenerative, or 
inflammatory lesions has now become established in medical practice.
    B. Covered Clinical Applications.--Although several uses of MRI are 
still considered investigational and some uses are clearly 
contraindicated (see subsection D), MRI is considered medically 
efficacious for a number of uses. Use the following descriptions as 
general guidelines or examples of what may be considered covered rather 
than as a restrictive list of specific coverages. Coverage is limited 
to MRI units which have received FDA premarket approval, and such units 
must be operated within the parameters specified by the approval. As 
with all items and services, the services must be reasonable and 
necessary for the diagnosis or treatment of the specific patient 
involved.
    MRI is useful in examining the head, central nervous system, and 
spine. Multiple sclerosis can be diagnosed with MRI and the contents of 
the posterior fossa are visible. The inherent tissue contrast 
resolution of MRI makes it an appropriate standard diagnostic modality 
for general neuroradiology.
    MRI can assist in the differential diagnosis of mediastinal and 
retroperitoneal masses, including abnormalities of the large vessels 
such as aneurysms and dissection. When a clinical need exists to 
visualize the parenchyma of solid organs to detect anatomic disruption 
or neoplasia, this can be accomplished in the liver, urogenital system, 
adrenals, and pelvic organs without the use of radiological contrast 
materials. When MRI is considered reasonable and necessary, the use of 
paramagnetic contrast materials may be covered as part of the study. 
MRI may also be used to detect and stage pelvic and retroperitoneal 
neoplasms and to evaluate disorders of cancellous bone and soft 
tissues. It may also be used in the detection of pericardial 
thickening.
    Primary and secondary bone neoplasm and aseptic necrosis can be 
detected at an early stage and monitored with MRI. Patients with 
metallic prostheses, especially of the hip, can be imaged in order to 
detect the early stages of infection of the bone to which the prothesis 
is attached.
    Effective for services provided on or after 03/22/94 MRI may also 
be covered to diagnose disc disease without regard to whether 
radiological imaging has been tried first to diagnose the problem.
    C. Gating Devices and Surface Coils (Effective for Services On or 
After
3/04/91).--Gating devices which eliminate distorted images caused by 
cardiac and respiratory movement cycles are now considered state of the 
art techniques and may be covered. Surface and other specialty coils 
may also be covered, as they are used routinely for high resolution 
imaging where small limited regions of the body are studied. They 
produce high signal-to-noise ratios resulting in images of enhanced 
anatomic detail.
    D. Contraindications and Non-Covered Uses.--
    1. Contraindications.--MRI is not covered when the following 
patient-specific contraindications are present. It is not covered for 
patients with cardiac pacemakers or with metallic clips on vascular 
aneurysms. MRI during a viable pregnancy is also contraindicated at 
this time. The danger inherent in bringing ferromagnetic materials 
within range of MRI units generally constrains the use of MRI on 
acutely ill patients requiring life support systems and monitoring 
devices which employ ferromagnetic materials. In addition, the long 
imaging time and the enclosed position of the patient may result in 
claustrophobia, making patients who have a history of claustrophobia 
unsuitable candidates for MRI procedures.
    2. Non-Covered Uses.--Several uses of MRI have been identified as 
investigational and are not covered. These include measurement of blood 
flow and spectroscopy. In addition, MRI is not suitable for the imaging 
of cortical bone and calcifications and for procedures involving 
spatial resolution of bone or calcifications.

[FR Doc. 94-19111 Filed 8-4-94; 8:45 am]
BILLING CODE 4120-01-P