98-14307. Medicare Program; Withdrawal of Proposed Notice and Request for Assessment on the Salitron System for the Treatment of Xerostomia (Dry Mouth) Secondary to Sjogren's Syndrome  

  • [Federal Register Volume 63, Number 104 (Monday, June 1, 1998)]
    [Notices]
    [Page 29743]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-14307]
    
    
    
    [[Page 29743]]
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Health Care Financing Administration
    [HCFA-3782-NC]
    RIN 0938-AG45
    
    
    Medicare Program; Withdrawal of Proposed Notice and Request for 
    Assessment on the Salitron System for the Treatment of Xerostomia (Dry 
    Mouth) Secondary to Sjogren's Syndrome
    
    AGENCY: Health Care Financing Administration (HCFA), HHS.
    
    ACTION: Withdrawal of Notice, and Request for Comments.
    
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    SUMMARY: This notice announces our withdrawal of a prior proposed 
    notice. It also announces a request for the Agency for Health Care 
    Policy and Research to conduct a new technology assessment on the 
    salivary electrostimulation in Sjogren's Syndrome which includes the 
    use of the Salitron System for the treatment of xerostomia (Dry Mouth) 
    secondary to Sjogren's Syndrome.
    
    DATES: Comments will be considered if we receive them at the 
    appropriate address, as provided below, no later than 5 p.m. on July 
    31, 1998.
    
    ADDRESSES: Mail written comments (1 original and 3 copies) to both the 
    following addresses:
    
    Health Care Financing Administration, Department of Health and Human 
    Services, Attention: HCFA-3782-NC, PO Box 26688, Baltimore, MD 21207, 
    and
    Agency for Health Care Policy and Research Attention: HCFA-3782-NC, 
    Willco Building, Suite 309, 6000 Executive Boulevard, Rockville, 
    Maryland 20852.
    
        If you prefer, you may deliver your written comments to one of the 
    following addresses:
    
    Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
    Washington, DC 20201, or
    Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    
        Because of staffing and resource limitations, we cannot accept 
    comments by facsimile (FAX) transmission. In commenting, please refer 
    to file code HCFA-3782-NC. Comments received timely will be available 
    for public inspection as they are received, generally beginning 
    approximately 3 weeks after publication of a document, in Room 309-G of 
    the Department's offices at 200 Independence Avenue, SW., Washington, 
    DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m. 
    (phone: (202) 690-7890).
    
    FOR FURTHER INFORMATION CONTACT: Francina C. Spencer, (410) 786-4614.
    
    SUPPLEMENTARY INFORMATION: On May 23, 1994, we published a notice in 
    the Federal Register (59 FR 26653) entitled, ``Noncoverage of 
    Electrostimulation of Salivary Glands for the Treatment of Xerostomia 
    (Dry Mouth).'' That notice announced our intent not to cover 
    electrostimulation of the salivary glands for the treatment of 
    xerostomia secondary to Sjogren's Syndrome and electrostimulation 
    devices, such as the Salitron System, under the Medicare program. The 
    notice took into account and provided details of a technology 
    assessment submitted to the Health Care Financing Administration in 
    1990 by the Office of Health Technology Assessment (OHTA).
        However, due to the lapse of time from the date the original 
    technology assessment was done (in 1990), we have decided to withdraw 
    the notice that was issued in the Federal Register in 1994, (FR Doc. 
    94-12457) and take no further action pursuant to that notice. Instead, 
    before we make a coverage determination, we believe it would be 
    appropriate to obtain an updated assessment to take into account 
    research and data made available since 1990. Therefore, we have 
    requested the Agency for Health Care Policy and Research (AHCPR), the 
    organization we now deal with for such issues, to do a technology 
    assessment of the Salitron System. We will make a decision regarding 
    the coverage of electrostimulation of the salivary glands for the 
    treatment of xerostomia secondary to Sjogren's Syndrome once we have 
    received and reviewed the new technology assessment from AHCPR.
        Any comments or significant data regarding the study of 
    electrostimulation of the salivary glands for the treatment of 
    xerostomia secondary to Sjogren's Syndrome should be submitted to both 
    the Agency for Health Care Policy and Research and HCFA at the 
    addresses provided above.
        Until a decision is made, Medicare coverage for electrostimulation 
    of the salivary glands for the treatment of xerostomia secondary to 
    Sjogren's Syndrome and the Salitron System will continue to be at the 
    discretion of the Medicare program durable medical equipment regional 
    carriers.
    
    Response to Comments
    
        Because of the large number of items of correspondence we normally 
    receive on Federal Register documents published for comment, we are not 
    able to acknowledge or respond to them individually. We will consider 
    all comments we receive by the date and time specified in the DATES 
    section of this preamble, and, if we proceed with a subsequent 
    document, we will respond to the comments in the preamble to that 
    document.
    
        Authority: Secs. 1861 and 1862 of the Social Security Act (42 
    U.S.C. 1395x and 1395y).
    
    (Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
    Assistance Program; No. 93.773 Medicare--Hospital Insurance Program; 
    and No. 93.774, Medicare--Supplementary Medical Insurance Program)
    
        Dated: April 28, 1998.
    Nancy-Ann Min DeParle,
    Administrator, Health Care Financing Administration.
    
        Dated: May 13, 1998.
    Donna E. Shalala,
    Secretary, Department of Health and Human Services.
    [FR Doc. 98-14307 Filed 5-29-98; 8:45 am]
    BILLING CODE 4120-01-P
    
    
    

Document Information

Published:
06/01/1998
Department:
Health Care Finance Administration
Entry Type:
Notice
Action:
Withdrawal of Notice, and Request for Comments.
Document Number:
98-14307
Dates:
Comments will be considered if we receive them at the
Pages:
29743-29743 (1 pages)
Docket Numbers:
HCFA-3782-NC
RINs:
0938-AG45: Request for Assessment on the Salitron System for the Treatment of Xerostomia Secondary to Sjogren's Syndrome (HCFA-3782-NC)
RIN Links:
https://www.federalregister.gov/regulations/0938-AG45/request-for-assessment-on-the-salitron-system-for-the-treatment-of-xerostomia-secondary-to-sjogren-s
PDF File:
98-14307.pdf