[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