95-28172. Medicare and Medicaid Programs; Quarterly Listing of Program Issuances and Coverage DecisionsSecond Quarter 1995  

  • [Federal Register Volume 60, Number 220 (Wednesday, November 15, 1995)]
    [Notices]
    [Pages 57435-57448]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-28172]
    
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    [BPO-132-N]
    
    
    Medicare and Medicaid Programs; Quarterly Listing of Program 
    Issuances and Coverage Decisions--Second Quarter 1995
    
    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 April, May, and June of 
    1995 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 
    April 1 and June 30, 1995. On August 21, 1989, we published the content 
    of the Manual (54 FR 34555) 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) 786-5255 (For Medicare instruction information).
    
    Pat Prete, (410) 786-3246 (For Medicaid instruction information).
    
    Nancy Ranels, (410) 786-8928 (For all other information). 
    
    [[Page 57436]]
    
    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 April 
    1 through June 1995.
    
    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 June 30, 1995. 
    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).
    
    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 
    
    [[Page 57437]]
    
    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 
    ``Beneficiary Services,'' use the Superintendent of Documents No. HE 
    22.8/7-3 and the HCFA transmittal number 132.
    
    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, Bureau of Program Operations, Issuances Staff, 
    Health Care Financing Administration, S3-01-27, 7500 Security Blvd., 
    Baltimore, MD 21244-1850, Telephone (410) 786-5255.
        Questions concerning Medicaid items in Addenda III may be addressed 
    to Pat Prete, Medicaid Bureau, Office of Medicaid Policy, Health Care 
    Financing Administration, C4-25-02, 7500 Security Boulevard, Baltimore, 
    MD 21244-1850, Telephone (410) 786-3246.
        Questions concerning all other information may be addressed to 
    Nancy Ranels, Bureau of Policy Development, Office of Regulations, 
    Health Care Financing Administration, C5-09-05, 7500 Security Blvd., 
    Baltimore, MD 21244-1850, Telephone (410) 786-8928.
    
    (Catalog of Federal Domestic Assistance Program No. 93.773, 
    Medicare--Hospital Insurance, Program No. 93.774, Medicare--
    Supplementary Medical Insurance Program, and Program No. 93.714, 
    Medical Assistance Program)
    
        Dated: November 3, 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 of the quarterly 
    updates to the Coverage Issues Manual published between March 20, 1990 
    through November 14, 1994, please refer to the January 3, 1995 update 
    (60 FR 134).
    
    January 3, 1995 (60 FR 132)
    April 6, 1995 (60 FR 17538)
    July 26, 1995 (60 FR 38344)
    
    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 57438]]
            Addendum III.--Medicare and Medicaid Manual Instructions        
                            [April through June 1995]                       
    ------------------------------------------------------------------------
       Trans. No.                     Manual/Subject/Publication No.        
    ------------------------------------------------------------------------
                              Intermediary Manual                           
                         Part 2--Audits, Reimbursement                      
                    Program Administration (HCFA-Pub. 13-2)                 
                  (Superintendent of Documents No. HE 22.8/6-1)             
    ------------------------------------------------------------------------
                       The patient must be an insulin-treated diabetic;
         The patient's physician states that the patient is capable 
    of being trained to use the particular device prescribed in an 
    appropriate manner. In some cases, the patient may not be able to 
    perform this function, but a responsible individual can be trained to 
    use the equipment and monitor the patient to assure that the intended 
    effect is achieved. This is permissible if the record is properly 
    documented by the patient's physician; and
         The device is designed for home rather than clinical use.
        There is also a blood glucose monitoring system designed especially 
    for use by those with visual impairments. The monitors used in such 
    systems are identical in terms of reliability and sensitivity to the 
    standard blood glucose monitors described above. They differ by having 
    such features as voice synthesizers, automatic timers, and specially 
    designed arrangements of supplies and materials to enable the visually 
    impaired to use the equipment without assistance.
        These special blood glucose monitoring systems are covered under 
    Medicare if the following conditions are met:
         The patient and device meet the four conditions listed 
    above for coverage of standard home blood glucose monitors; and
         The patient's physician certifies that he or she has a 
    visual impairment severe enough to require use of this special 
    monitoring system.
        The additional features and equipment of these special systems 
    justify a higher reimbursement amount than allowed for standard blood 
    glucose monitors. Separately identify claims for such devices and 
    establish a separate reimbursement amount for them. For those carriers 
    using HCPCS, the procedure code and definition is: EO609--Blood Glucose 
    Monitor--with special features (e.g., voice synthesizers, automatic 
    timer).
        Transmittal No. 76; sections 50-36--50-39.1 Positron Emission 
    Tomography (PET or PETT) Scans--New Implementing Instructions--
    Effective Date: Services furnished on or after March 14, 1995.
        Section 50-36, Positron Emission Tomography (PET or PETT) Scans.--
    This section is revised to provide limited coverage of positron 
    emission tomography scans. Previously, PET scans were considered 
    experimental by HCFA. PET scans are covered for use in noninvasive 
    imaging of the perfusion of the heart for diagnosis and management of 
    patients with known or suspected coronary artery disease. Coverage is 
    limited to scans which employ Rubidium-82, done on equipment approved 
    by the Food and Drug Administration, and when done in place of, but not 
    in addition to a single photon emission computed tomography (SPECT) 
    scan. PET centers must file claims for Medicare beneficiaries using 
    specific G codes, and provide information regarding the results of 
    previous tests. PET centers are also expected to maintain patient 
    records for each Medicare patient with sufficient information to 
    substantiate the need for the scan. 
    
    [[Page 57446]]
    
    50-36  Positron Emission Tomography (Pet or Pett) Scans (Effective for 
    Services Performed on or After March 14, 1995)
        Positron emission tomography (PET), also known as positron emission 
    transverse tomography (PETT), is a noninvasive imaging procedure that 
    assesses perfusion and the level of metabolic activity in various organ 
    systems of the human body. A positron camera (tomograph) is used to 
    produce cross-sectional tomographic images by detecting radioactivity 
    from a radioactive tracer substance (radiopharmaceutical) that is 
    injected into the patient.
        Until recently Medicare considered PET scans experimental and, 
    therefore, not covered. HCFA has now concluded that one use of PET 
    scans, imaging of the perfusion of the heart using Rubidium 82 (Rb 82), 
    is no longer experimental, and may be covered, provided that several 
    conditions, outlined below, are met. This conditional coverage is 
    dictated by two significant factors that apply to PET scans.
        First, although PET is no longer considered experimental for this 
    single use, it duplicates other covered forms of diagnostic testing, 
    and the degree to which PET scans may substitute as primary tests for 
    such uses, as compared to a confirming or medically necessary 
    additional test, is not as clear as is preferable. For example, in the 
    case of imaging perfusion of the heart, body size and type may result 
    in a technically uninterpretable single photon emission computed 
    tomography (SPECT) test in some cases, necessitating a PET scan in 
    order to produce clearer images and allow diagnosis and treatment of 
    the patient.
        Second, the Food and Drug Administration (FDA) has approved only 
    Rubidium 82 for general PET scan use. The FDA considers 
    radiopharmaceuticals drugs, subject to all of the requirements for 
    manufacture, testing and approval (including approval for certain 
    specific uses) that the FDA applies to all drugs. Thus some uses of PET 
    cannot be considered for coverage due to the lack of approval of the 
    radiopharmaceuticals involved in those uses.
        Although the FDA has approved another radiopharmaceutical (deoxy-2-
    Fluoro-D-glucose (FDG)), that approval is very limited and is 
    restricted to a single PET site at this time. The FDA currently 
    requires each site to submit its version of FDG for testing and 
    approval as a new drug. In view of these restrictions, coverage of PET 
    with FDG is not being considered at this time. HCFA will continue to 
    monitor the use of PET with FDG, with a view toward considering 
    coverage of such uses when they appear appropriate.
        The following coverage requirements must be met to assure that PET 
    scans (1) are medically necessary, (2) do not unnecessarily duplicate 
    other covered diagnostic tests, and (3) do not involve investigational 
    drugs or procedures using investigational drugs.
        A. Approved Sites.--PET scans may be covered only at PET imaging 
    centers with PET scanners that have been approved by the FDA. Medicare 
    contractors must determine, prior to making payment for any PET scans, 
    whether the center applying for payment has an FDA-approved scanner.
        B. Use of Rubidium 82 (Rb 82) and Related Tests.--Coverage of PET 
    scans under Medicare is currently limited to rest alone or rest with 
    pharmacologic stress PET scans used for noninvasive imaging of the 
    perfusion of the heart for the diagnosis and management of patients 
    with known or suspected coronary artery disease using the FDA-approved 
    radiopharmaceutical Rubidium 82 (Rb 82). Coverage is further limited to 
    scans that meet either one of the following conditions:
         The PET scan, whether rest alone or rest with stress, is 
    used in place of, but not in addition to, a single photon emission 
    computed tomography (SPECT); or
         The PET scan, whether rest alone or rest with stress, is 
    used following a SPECT that was found inconclusive. In these cases, the 
    PET scan must have been considered necessary in order to determine what 
    medical or surgical intervention is required to treat the patient. (For 
    purposes of this requirement, an inconclusive test is a test(s) whose 
    results are equivocal, technically uninterpretable, or discordant with 
    a patient's other clinical data.)
    
        Note: PET scans using Rubidium 82, whether rest or stress are 
    not covered by Medicare for routine screening of asymptomatic 
    patients, regardless of the level of risk factors applicable to such 
    patients.
    
        C. Submission of Claims Data.--Claims for PET scans must include 
    the following information. Failure to submit this information may 
    result in denial of a claim.
        The PET center must, for any PET scan for which payment is claimed, 
    complete all required information on the claim form (including proper 
    codes and modifiers) to indicate the results of the PET scan, as well 
    as information as to whether the PET scan was done after an 
    inconclusive noninvasive cardiac test. The information submitted with 
    respect to the previous cardiac test must specify the type of test done 
    prior to the PET scan and whether it was inconclusive or 
    unsatisfactory. These explanations are in the form of special G codes 
    used for billing PET scans.
        D. Maintenance of Patient Record Data Onsite.--In view of these 
    limitations on coverage, HCFA may decide to conduct some post-payment 
    reviews to determine that the use of PET scans is consistent with this 
    instruction. PET centers must keep patient record information on file 
    for each Medicare patient for whom a PET scan claim is made. These 
    medical records will be used in any post-payment reviews and must 
    include the information necessary to substantiate the need for the PET 
    scan. The records must include standard information (e.g., age, sex, 
    and height) along with any annotations regarding body size or type 
    which indicated a need for a PET scan to determine that patient's 
    condition (i.e., any reason the nature of the patient's body size or 
    type mandated the use of a PET scan in order to continue treatment).
        Transmittal No. 77; sections 60-16--60-19 (Cont.) Pneumatic 
    Compression Devices (Used for Lymphedema) CLARIFICATION--Effective 
    Date: Not Applicable.
        Section 60-16, Pneumatic Compression Devices (Used for 
    Lymphedema).--This section is revised to clairfy (1) That the 
    nonsegmented and segmented pump without manual control of pressure in 
    each chamber is considered the least costly alternative that meets the 
    clinical needs of the individual for this type of durable medical 
    equipment (HCPCS codes E0650 and E0651), unless there is documentation 
    that warrants payment of the more costly manual control pump (HCPCS 
    code E0652); (2) the documentation needed for determination of the type 
    of pump to be used for the treatment of lymphedema; and (3) which 
    pneumatic compression pump is appropriate for chronic venous 
    insufficiency. 60-16 Pneumatic Compression Devices (used for 
    Lymphedema)
        Lymphedema is the swelling of subcutaneous tissues due to the 
    accumulation of excessive lymph fluid. The accumulation of lymph fluid 
    results from an impairment to the normal clearing function of the 
    lymphatic system and/or from an excessive production of lymph. It is a 
    relatively uncommon, chronic condition which may be due to many causes, 
    e.g., surgical removal of lymph nodes, post radiation fibrosis, 
    scarring of lymphatic 
    
    [[Page 57447]]
    channel, onset of puberty (Milroy's Disease), and congenital anomalies. 
    In the home setting, both the segmental and nonsegmental pneumatic 
    compression devices are covered only for the treatment of generalized, 
    refractory lymphedema.
        Pneumatic compression devices are only covered as a treatment of 
    last resort, i.e., other less intensive treatments must have been tried 
    first and found inadequate. Such treatments would include leg or arm 
    elevation and custom fabricated gradient pressure stockings or sleeves.
        Pneumatic compression devices may be covered only when prescribed 
    by a physician and when they are used with appropriate physician 
    oversight, i.e., physician evaluation of the patient's condition to 
    determine medical necessity of the device, suitable instruction in the 
    operation of the machine, a treatment plan defining the pressure to be 
    used and the frequency and duration of use, and ongoing monitoring of 
    use and response to treatment.
        The determination by the physician of the medical necessity of a 
    pneumatic compression device must include (1) The patient's diagnosis 
    and prognosis; (2) symptoms and objective findings, including 
    measurements which establish the severity of the condition; (3) the 
    reason the device is required, including the treatments which have been 
    tried and failed; and (4) the clinical response to an initial treatment 
    with the device. The clinical response includes the change in pre-
    treatment measurements, ability to tolerate the treatment session and 
    parameters, and ability of the patient (or caregiver) to apply the 
    device for continued use in the home.
        In general, the nonsegmented (HCPCS code E0650) or segmented (HCPCS 
    code E0651) compression device without manual control of pressure in 
    each chamber is considered the least costly alternative that meets the 
    clinical needs of the individual.
        Therefore, when a claim for a segmented pneumatic compression 
    device which allows for manual control in each chamber is received, 
    payment must be made for the least expensive medically appropriate 
    device. If the patient medically needs a segmented device but does not 
    need manual controls, payment must be made for HCPCS code E0651. The 
    segmented device with manual control (HCPCS code E0652) is covered only 
    when there are unique characteristics that prevent the individual from 
    receiving satisfactory pneumatic treatment using a less costly device, 
    e.g., significant sensitive skin scars or the presence of contracture 
    or pain caused by a clinical condition that requires the more costly 
    manual control device.
        The use of pneumatic compression devices may be medically 
    appropriate only for those patients with generalized, refractory edema 
    from venous insufficiency with lymphatic obstruction (i.e., recurrent 
    cellulitis with secondary scarring of the lymphatic system) with 
    significant ulceration of the lower extremity(ies) who have received 
    repeated, standard treatment from a physician using such methods as a 
    compression bandage system or its equivalent, but fail to heal after 6 
    months of continuous treatment. The exact nature of the medical problem 
    must be clear from the medical evidence submitted. If, after obtaining 
    this information, a question of medical necessity remains, the 
    contractor's medical staff resolves the issue.
    
                                               Addendum V.--Regulation Documents Published in the Federal Register                                          
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                                FR Vol. 60                                                                                    End of comment                
        Publication date           page          CFR part             File code                   Regulation title                period      Effective date
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    04/06/95................     17538-17547  ..............  BPO-130-N...............  Medicare and Medicaid Programs;       ..............        04/06/95
                                                                                         Quarterly Listing of Program                                       
                                                                                         Issuances and Coverage Decisions--                                 
                                                                                         Fourth Quarter 1994.                                               
    04/10/95................     18136-18137  ..............  MB-084-N................  Medicaid Program; Rescission of the   ..............  ..............
                                                                                         Guidelines for Documenting Medicaid                                
                                                                                         Recipient Access to Immunizations                                  
                                                                                         Under the Vaccines for Children                                    
                                                                                         (VFC) Program.                                                     
    04/20/95................           19753  ..............  OFHR-001-N..............  New Address and Telephone Numbers of  ..............        05/22/95
                                                                                         the Office of Acquisition and                                      
                                                                                         Grants, Office of Financial and                                    
                                                                                         Human Resources.                                                   
    04/21/95................     19856-19862        440, 441  MB-041-F................  Medicaid Program; Required Coverage   ..............        05/22/95
                                                                                         Of Nurse Practitioner Services.                                    
    04/24/95................     20035-20051             493  HSQ-216-FC..............  CLIA Program; Categorization of             06/23/95        04/24/95
                                                                                         Tests and Personnel Modifications.                                 
    05/01/95................           21048             421  BPO-083-F...............  Medicare Program; Revisions to        ..............        05/01/95
                                                                                         Criteria and Standards for                                         
                                                                                         Evaluating Intermediaries and                                      
                                                                                         Carriers (Correction).                                             
    05/03/95................     21824-21825  ..............  HSQ-227-N...............  Medicaid Program; Peer Review         ..............        05/03/95
                                                                                         Organization Contracts:                                            
                                                                                         Solicitation of Statements of                                      
                                                                                         Interest From In-State                                             
                                                                                         Organizations-Alaska, Delaware, the                                
                                                                                         District of Columbia, Idaho,                                       
                                                                                         Kentucky, Maine, Nebraska, Nevada,                                 
                                                                                         South Carolina, Vermont, and                                       
                                                                                         Wyoming.                                                           
    05/08/95................     22533-22535             406  BPD-738-F...............  Medicare Program; Clarification of    ..............        06/07/95
                                                                                         Resumption of Entitlement Rules for                                
                                                                                         Medicare Patients With End-Stage                                   
                                                                                         Renal Disease (ESRD).                                              
    05/25/95................           27736  ..............  OPL-005-N...............  Medicare Program; June 12, 1995       ..............        05/25/95
                                                                                         Meeting of the Practicing                                          
                                                                                         Physicians Advisory Council.                                       
    06/02/95................     29202-29434  412, 485, 413,  BPD-825-P...............  Medicare Program; Changes to the            08/01/95  ..............
                                                    489, 424                             Hospital Inpatient Prospective                                     
                                                                                         Payment Systems and Fiscal Year                                    
                                                                                         1996 Rates.                                                        
    06/12/95................     30877-30891  ..............  BPD-832-N...............  Medicaid Program; HHS' Approval of    ..............       08/11/95 
                                                                                         NAIC Statements Relating to                                        
                                                                                         Duplication of Medicare Benefits.                                  
    
    [[Page 57448]]
                                                                                                                                                            
    06/13/95................     31158-31161  ..............  ORD-075-N...............  New and Pending Demonstration         ..............        06/13/95
                                                                                         Project Proposals Submitted                                        
                                                                                         Pursuant to Section 1115(a) of the                                 
                                                                                         Social Security Act: February and                                  
                                                                                         March 1995.                                                        
    06/27/95................     31126-31137  ..............  BPD-366-F...............  Medicare Program; Clarification of    ..............        07/27/95
                                                                                         Medicare's Accrual Basis of                                        
                                                                                         Accounting Policy.                                                 
    06/27/95................     33123-33126             413  BPD-689-F...............  Medicare Program; Uniform Electronic  ..............        07/27/95
                                                                                         Cost Reporting System for Hospitals.                               
    06/27/95................     33262-33298  417, 483, 430,  BPD-718-F...............  Medicare and Medicaid Programs;       ..............        07/27/95
                                              484, 431, 489,                             Advance Directives.                                                
                                                         434                                                                                                
    06/27/95................     33137-33143  ..............  BPD-794-F...............  Medicare Program; Date for Filling    ..............        06/27/95
                                                                                         Medicare Cost Reports.                                             
    06/27/95................     33221-33224  ..............  ORD-076-N...............  New and Pending Demonstration         ..............       06/27/95 
                                                                                         Project Proposals Submitted                                        
                                                                                         Pursuant to Section 1115(a) of the                                 
                                                                                         Social Security Act: April 1995.                                   
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    * 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. 95-28172 Filed 11-14-95; 8:45 am]
    BILLING CODE 4120-01-P
    
    

Document Information

Published:
11/15/1995
Department:
Health and Human Services Department
Entry Type:
Notice
Action:
Notice.
Document Number:
95-28172
Dates:
For Services Furnished On or After 04/27/95.
Pages:
57435-57448 (14 pages)
Docket Numbers:
BPO-132-N
PDF File:
95-28172.pdf