[Federal Register Volume 71, Number 231 (Friday, December 1, 2006)]
[Notices]
[Pages 69567-69568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-9485]



[[Page 69567]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, Department of 
Health and Human Services.

ACTION: Notice.

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SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) allow the proposed information collection 
project: ``Evaluation of a Medication Therapy Management Program to 
Improve Patient Safety in Medicare Beneficiaries.'' In accordance with 
the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 
3506(c)(2)(A)), AHRQ invites the public to comment on this proposed 
information collection.

DATES: Comments on this notice must be received by January 30, 2007.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, 540 Gaither Road, Room <greek-i>5036, 
Rockville, MD 20850.
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from AHRQ's Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ, Reports 
Clearance Officer, (301) 427-1477.

SUPPLEMENTARY INFORMATION: 

Proposed Project

``Evaluation of a Medication Therapy Management Program (MTMP) To 
Improve Patient Safety in Medicare Beneficiaries''

    The Medicare Modernization Act of 2003 (MMA) requires Medicare 
prescription drug plans to have a MTMP that is developed in cooperation 
with licensed and practicing pharmacists and physicians for targeted 
beneficiaries. MTMP is defined in the MMA as a program of drug therapy 
management that is designed to assure, with respect to targeted 
beneficiaries, that covered part D drugs are appropriately used to 
optimize therapeutic outcomes through improved medication use, and to 
reduce the risk of adverse events, including adverse drug interactions.
    The proposed MTMP research project will prospectively evaluate the 
effects of a specific drug therapy management program on health 
outcomes and patient safety in a group of research subjects aged 65 or 
older, living with multiple chronic health conditions and taking 
multiple part D medications. The evaluation will be designed as a 
randomized, controlled study with subjects recruited from multiple 
ambulatory care or family practice medical clinics in the States of 
Illinois, North Carolina, and Texas. The study will be coordinated by 
clinical scientists, physicians, and pharmacists affiliated with AHRQ, 
Baylor Health Care System, Duke University, RTI International, and the 
University of Illinois at Chicago.
    The study protocol and data collection procedures for the MTMP 
research evaluation will be reviewed by the official Institutional 
Review Boards at each participating study site. The study will be 
conducted in accordance with the rules and regulations of the Health 
Insurance Protection and Portability Act and with the ``Guidelines for 
the Conduct of Research Involving Human Subjects.'' An informed consent 
will be obtained (see Table below) prior to subject enrollment in the 
study. For individuals who consent to participate, confidential 
identifiable information will be collected as described in the informed 
consent document. Subjects will be asked to provide information about 
medication use, adherence to prescription instructions, health services 
use, health status, adverse drug events, satisfaction with the MTMP, 
and demographics. Study pharmacists will assess subjects' medication 
use, the appropriateness of each prescribed medication using a 
validated scale, and will provide information about their own 
satisfaction with the MTMP. All study information will be entered and 
maintained in a secure, password-protected database and will be 
protected in accordance with AHRQ's confidentiality statute, Section 
934(c) of the Public Health Service Act (42 U.S.C. 299c-3(c)).

Methods of Collection

    The data will be collected using several methods at study entry and 
at the end of the study. Questionnaire data will be obtained via direct 
patient interview by clinical investigators who will record the 
information on a paper form. In addition, a self-administered paper 
patient survey will be collected during scheduled patient study visits 
in both the intervention and control arms to assess the effects of 
participation in the medication therapy management program. All survey 
forms will be entered and maintained in a secure, password-protected 
database. Patient health, medication history, and hospitalization 
information will be obtained through a review of the subjects' 
electronic or paper medical records. Information on prescriptions 
filled (e.g., number of tablets, directions, date filled) and refill 
frequency will be obtained through electronic pharmacy records, when 
these records are available and when access is authorized by the 
subject.

Estimated Annual Respondent Burden

    The Table below indicates the total time burden required to obtain 
all of the data required to meet the study's objectives. The Table does 
not include time required to analyze the data and prepare it for 
statistical reporting, analysis and publication.

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                                                               Number of       Average burden
  Respondents and response type    Number of  respondents    responses per      per response      Total burden
                                                              respondent          (hours)            (hours)
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Study Participants/Informed        400...................                 1               0.25               100
 Consent.
Study Participants/Patient Survey  400...................                 2               0.75               600
Study Investigators and Personnel/ 400...................                 1               0.25               100
 Informed Consent.
Study Investigators and Personnel/ 400...................                 2               0.75               600
 Patient Survey.
Study Investigators and Personnel/ 400...................                 2               1                  800
 Medical Chart Review and
 Abstraction.
Study Investigators and Personnel/ 4 (from 4 different                    2               4                   32
 Preparing Electronic Pharmacy      sites).
 Records.
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    Total........................  ......................  ................  .................              2232
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Estimated Costs to the Federal Government

    The cost estimate to the federal government is $1,400,000.

Request for Comments

    In accordance with the above-cited legislation, comments on AHRQ's 
information collection are requested with regard to any of the 
following: (a) Whether the proposed collection of information is 
necessary for the proper performance of health care research and 
information dissemination functions of AHRQ, including whether the 
information will have practical utility; (b) the accuracy of AHRQ's 
estimate of burden (including hours and costs) of the proposed 
collection(s) of information; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information upon the 
respondents, including the use of automated collection techniques or 
other forms of information technology.
    Comments submitted in response to this notice will be summarized 
and included in the request for OMB approval of the proposed 
information collection. All comments will become a matter of public 
record.

    Dated: November 20, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06-9485 Filed 11-30-06; 8:45 am]
BILLING CODE 4160-90-M