[Federal Register Volume 65, Number 147 (Monday, July 31, 2000)]
[Notices]
[Pages 46722-46724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19182]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA-10014]


Emergency Clearance: Public Information Collection Requirements 
Submitted to the Office of Management and Budget (OMB)

AGENCY: Health Care Financing Administration, HHS.
    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Health Care Financing 
Administration (HCFA), Department of Health and Human Services, is 
publishing the following summary of proposed collections for public 
comment. Interested persons are invited to send comments regarding this 
burden estimate or any other aspect of this collection of information, 
including any of the following subjects: (1) The necessity and utility 
of the proposed information collection for the proper performance of 
the agency's functions; (2) the accuracy of the estimated burden; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) the use of automated collection techniques or 
other forms of information technology to minimize the information 
collection burden.
    We are, however, requesting an emergency review of the Information 
collections referenced below. In compliance with the requirement of 
section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have 
submitted to the Office of Management and Budget (OMB) the following 
requirements for emergency review. We are requesting an emergency 
review because the collection of this information is needed prior to 
the expiration of the normal time limits under OMB's regulations at 5 
CFR part 1320. Due to an unanticipated event, we are requesting an 
emergency review because the data collection and the associated time 
frame is required by a Congressionally mandated demonstration project 
(Informatics, Telemedicine, and Education Demonstration Project). This 
project is defined under Section 4207 of the Balanced Budget Act of 
1997 which specifies an overall time frame of four years. In order to 
meet this overall time frame study the pilot phase for the recruitment 
of subjects should begin in late August 2000, with the full 
implementation of the recruitment phase beginning on October 1, 2000. 
Subject recruitment, in turn, will involve data collection involved in 
the Paper Reduction Act submission.
    HCFA is requesting OMB review and approval of this collection by 8/
7/2000, with a 180-day approval period. Written comments and 
recommendations will be accepted from the public if received by the 
individuals designated below by 8/3/2000. During this 180-day period, 
we will publish a separate Federal Register notice announcing the 
initiation of an extensive 60-day agency review and public comment 
period on these requirements. We will submit the requirements for OMB 
review and an extension of this emergency approval.
    Type of Information Collection Request: New Collection;
    Title of Information Collection: Informatics, Telemedicine, and 
Education Demonstration Project;
    Form No.: HCFA-10014 (OMB# 0938-NEW);
    Use: Section 4207 of the Balanced Budget Act of 1997 mandated HCFA 
to conduct a demonstration project to evaluate the effectiveness of 
advanced computer and telecommunications technology (``telemedicine'') 
to manage the care of people with diabetes. HCFA issued a request for 
proposals and, after review of the responses, selected a consortium led 
by Columbia University to conduct this project.

[[Page 46723]]

    The consortium includes the following organizations and 
departments: Columbia University (Department of Medicine/Division of 
General Medicine, Department of Medical Informatics, and Russ Berrie 
Diabetes Center), NewYork Presbyterian Hospital, Harlem Hospital Center 
(Department of Medicine/Division of General Medicine, and Harlem 
Renaissance HealthCare Network), The Hebrew Home for the Aged at 
Riverdale, State University of New York (SUNY) Upstate Medical Center 
(Department of Medicine/Division of Endocrinology and Metabolism, 
Department of Family Medicine, Joslin Diabetes Center), Arnot Ogden 
Hospital, Olean General Hospital, Good Samaritan Hospital, American 
Diabetes Association, Bell Atlantic Telephone Co., and American 
TeleCare, Inc.
    The project is designed as a randomized controlled trial. Half of 
the participants will receive the intervention, consisting of a home 
telemedicine unit and electronic services that can be accessed through 
this unit, and half will continue to receive usual care. There will be 
an urban component, to be conducted in northern Manhattan, and a rural 
component, to be conducted in upstate New York with SUNY, as the hub. 
Half of the participants will come from the urban area and half from 
the rural area, and randomization will be blocked within these 
components. Eligibility for participation requires that subjects be 
eligible Medicare beneficiaries with diabetes mellitus, reside in a 
medically underserved area (either MUA or HPSA) at time of enrollment, 
possess mental and visual capacities required for meaningful 
participation, and provide written informed consent.
    Participants randomized to the intervention group will receive a 
home telemedicine unit (HTU) consisting of a web-enabled computer with 
modem connection to an existing telephone line. The HTU has several 
components: (a) a video camera and microphone that provides 8 frames/
sec video and voice conferencing with nurse case managers at the Berrie 
Diabetes Center at Columbia University (urban component) or the Joslin 
Diabetes Center at SUNY Upstate Medical Center (rural component), (b) 
an FDA-approved home glucometer and blood pressure cuff (connected to 
the HTU through a generic medical device data port) to enable uploading 
of home fingerstick glucose and blood pressure data into a high 
performance computer database (NewYork Presbyterian Hospital Clinical 
Information System ), (c) access to patients = own clinical data 
through graphic and other data displays, and (d) access to a special 
educational web page to be created for the project by the American 
Diabetes Association in English and Spanish and in regular and low-
literacy versions in each language.
    Nurse case managers will receive training in diabetes management, 
following the Veterans Hospital Administration diabetes guidelines, and 
in the use of computer-based case management tools. These tools will 
facilitate monitoring and interactions with patients through 
videoconferencing. The HTU devices will be provided by American 
TeleCare, Inc. Installation, training, help desk support, and de-
installation of the HTUs at the end of the project will be provided by 
Gentiva HealthServices.
    Sample size was determined using least detectable difference 
calculations, and was based on balancing adequacy of statistical power 
and involvement of the smallest number of subjects. Outcome parameters 
considered in these calculations included glycosylated hemoglobin, 
blood pressure levels, and others. These calculations assumed blocked 
randomization (urban and rural components), repeat measures at one and 
two years of follow-up, and attrition rates at two years of fifteen 
percent in the intervention group and twenty percent in the control 
group. The attrition assumption, which was purposely conservative, 
projects that approximately twelve hundred of the original fifteen 
hundred people randomized will fully complete the study. Baseline mean 
levels and standard deviations for glycosylated hemoglobin and systolic 
and diastolic blood pressures were based on reviews of published 
observational studies for subjects sixty five years of age and older.
    The sample size is adequate for an intervention effect on systolic 
blood pressure of 5 mm Hg reduction. Unadjusted for clustering and 
unreliability, with n=600 completers in each group, power is 0.97, 
while for an effect of 3 mmHg power is approximately 0.68. For 
glycosylated hemoglobin, it is noteworthy that tight glucose control in 
type 2 diabetics has a relatively modest effect compared to duration of 
diabetes on this parameter. Recent data (UKPDS 33; Lancet 1998; 
352:837-53) show that glycosylated hemoglobin levels continued to rise 
over time in both the intensively treated and control groups, although 
intervention resulted in lower levels compared to control. The power 
analysis indicated that a difference in mean glycosylated hemoglobin 
level of 0.6% (7.9% vs. 8.5% in the two groups) could be detected with 
a sample size of n=138 per group; adjustment for the cluster effect 
increased this number to 207 per group.
    Thus, the study is adequately powered to detect a difference of 
this magnitude in the overall study, and also possibly in subgroups 
defined by race/ethnicity, sex, or by urban/rural source. The study is 
not over-powered, since the intervention effect for this variable may 
be smaller, due to the older age and longer duration of diabetes in the 
subjects, and because subgroup analysis would be highly desirable.
    Project evaluation will comprise the following: (a) Feasibility 
will be assessed by whether the implementation is successful, (b) 
acceptability will be assessed by whether participants can use the 
devices effectively, like the devices and the electronic service 
delivery model of care, and are satisfied with their care, (c) 
effectiveness will be evaluated primarily by comparing mean and 
adjusted mean levels of clinical outcomes in the intervention vs. 
control groups, and (d) cost-effectiveness will be assessed based on 
effectiveness, measures of health care services utilization, and 
technology and service costs of the intervention.
    The demonstration will include collection of a comprehensive array 
of clinical, demographic, utilization, physician and patient 
satisfaction, and other data. Clinical data will be collected from all 
(intervention and control) participants at three visits: Visit 1 
(baseline), Visit 2 (one year follow-up), and Visit 3 (two year follow-
up). These data will include consent, demographics, medical and 
medication history, blood pressure, anthropometric data, fasting blood 
sample, and questionnaire data regarding health care service 
utilization, health status, smoking status, and satisfaction with care. 
Additional evaluation data will be collected from all participants by 
telephone at three-month intervals between the in-person visits. These 
data will focus on health care utilization and smoking status.
    Clinical data will be collected from participants in the 
intervention arm of the study through the HTU. Participants will be 
encouraged to use the HTU to interact with the nurse case manager and 
to take an active role in self-monitoring of home glucose and blood 
pressure levels. These data will be used in the clinical management of 
the intervention arm participants by the project nurse case managers as 
well as the participants own primary care providers, who will also 
receive these data. Intervention group participants

[[Page 46724]]

may provide as little or as much of this category of data as they 
choose.
    Frequency: Quarterly;
    Affected Public: Business or other for-profit, and Individuals or 
Households;
    Number of Respondents: 5,550;
    Total Annual Responses: 10,043;
    Total Annual Hours: 19,999.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access HCFA's 
Web Site address at http://www.hcfa.gov/regs/prdact95.htm, or E-mail 
your request, including your address, phone number, to 
[email protected], or call the Reports Clearance Office on (410) 786-
1326.
    Interested persons are invited to send comments regarding the 
burden or any other aspect of these collections of Information 
requirements. However, as noted above, comments on these Information 
collection and recordkeeping requirements must be mailed and/or faxed 
to the designees referenced below, by 8/3/2000:
Health Care Financing Administration, Office of Information Services, 
Security and Standards Group, Division of HCFA Enterprise Standards, 
Attention: Dawn Willinghan, Room N2-14-26, 7500 Security Boulevard, 
Baltimore, Maryland 21244-1850, and
Office of Information and Regulatory Affairs, Office of Management and 
Budget, Room 10235, New Executive Office Building, Washington, DC 
20503, Fax Number: (202) 395-6974 or (202) 395-5167, Attn: Allison 
Herron Eydt, HCFA Desk Officer.

    Dated: July 13, 2000.
John P. Burke III,
HCFA Reports Clearance Officer, HCFA Office of Information Services, 
Security and Standards Group, Division of HCFA Enterprise Standards.
[FR Doc. 00-19182 Filed 7-28-00; 8:45 am]
BILLING CODE 4120-03-P