[Federal Register Volume 72, Number 96 (Friday, May 18, 2007)]
[Notices]
[Pages 28053-28056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-2481]



[[Page 28053]]

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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.
    This proposed information collection was previously published in 
the Federal Register on December 1, 2006 and allowed 60 days for public 
comment.
    The purpose of this notice is to publish prior comments received 
and agency responses as well as allow an additional 30 days for public 
comment.
    Public comments were received and are included at the end of this 
notice, along with responses to the comments.

DATES: Comments on this notice must be received by June 18, 2007.

ADDRESSES: Written comments should be submitted to: Karen Matsuoka by 
fax at (202) 395-6974 (attention: AHRQ's desk office) or by e-mail at 
<a href="/cdn-cgi/l/email-protection#8dc2c4dfccd2fef8efe0e4fefee4e2e3cde2e0efa3e8e2fda3eae2fb"><span class="__cf_email__" data-cfemail="c7888e958698b4b2a5aaaeb4b4aea8a987a8aaa5e9a2a8b7e9a0a8b1">[email protected]</span></a> (attention: AHRQ's desk officer). 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 Privacy and Security regulations of 
the Health Insurance Protection and Portability Act, 45 CFR Parts 160, 
162 and 164 and with 45 CFR part 46, the ``Common rule'' regarding the 
Conduct of Research Involving Human Subjects. An informed consent with 
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, health service use, health status, adverse drug events, 
satisfaction with the MTMP, and demographics. Study pharmacists will 
assess subject's medication use, the appropriateness of each prescribed 
medication using a validated scale, and will provide information about 
their own satisfactions 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. 299 c-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 of the study 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, data 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.

----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                                     Number of      burden per     Total burden
     Respondents and response type       Number of  respondents    responses per     response         (hours)
                                                                    respondent        (hours)
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Study Participants/Informed Consent...  400.....................               1            0.25             100
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 Chat Review and Abstraction.

[[Page 28054]]

 
Study Investigators and Personnel/      4 (from 4 different                    2               4              32
 Preparing Electronic Pharmacy Records.  sites).
    Total.............................  ........................  ..............  ..............            2232
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** Refers to time on the part of investigators and study personnel in obtaining informed consent from subjects.

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 Paperwork Reduction Act 
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.

Comments on the 60 Day Notice Federal Register Notice

    Comment a: Study design favors self selection of patients who are 
mobile, able to accurately self-report data elements and have 
sufficient cognitive function and health status to benefit from patient 
education and participate for the study duration. How then will this 
study design inform about how to intervene for the oldest and sickest 
beneficiaries?
    Response: Clearly no single study can address all patient 
populations that might benefit from medication therapy management 
(MTM). In order for this study to be both practical and generalizable 
to the broadest range of Medicare beneficiaries, we have targeted those 
that are mobile, able to accurately self-report the required data 
elements and have sufficient cognitive function and health status to 
benefit from the intervention and participate for the study duration. 
Nevertheless, we recognize that certain patients may be at higher risk 
than others. Therefore, the protocol has been revised to focus on those 
beneficiaries at greater risk of drug related problems (DRPs) and 
adverse drug events (ADEs)--and thus presumably in the greatest need 
for medication therapy management (MTM). Entry criteria in the revised 
protocol include (1). must be least 65 years old as of August 1, 2007; 
(2). must have 3 or more comorbid conditions associated with increased 
healthcare utilization (conditions include diabetes mellitus, heart 
failure, asthma, hypertension, dyslipidemia, COPD, coronary artery 
disease, chronic renal failure, arthritis, depression, dementia, 
chronic pain, and conditions requiring anticoagulation); (3). must have 
visited a physician at one or more of the clinics on a regular basis 
(defined as 2 or more clinic visits over 1 year prior to the study 
start) for these condition; (4). must have received 8 or more different 
chronic prescription medications over the 6 months prior to the 
enrollment period; (5) must have a telephone line and agree to maintain 
it for at least 6 months; and (6). must have one of the following 
situations placing him/her at risk for a DRP: (a) ER visit in past 30 
days, (b) new physician in past 30 days, (c) hospitalization in past 30 
days, (d) change in mediation in past 30 days, or (e) 3 or more 
providers.
    Comment b: Although five specific services are identified, they are 
not standardized. Lack of a standardized intervention means that it 
will be impossible to draw valid comparisons between the control and 
intervention groups.
    Response: The intervention has been revised to focus on medication 
reconciliation and DRP assessment. The intervention will be well-
defined, with specific tools or ``aids'' for implementation, and it 
will be standardized across the study sites. A ``toolkit'' will be 
produced that will allow the intervention to be reproduced once the 
study is completed.
    Comment c: The identified interventions do not address the most 
critical element of MTM--assessment of the appropriateness of 
medications, including identification of untreated indications that 
would be followed by recommendations to prescribers. In the proposed 
study, while pharmacists will be addressing continuity of care, the 
assumption appears to be that the initial prescription choice is always 
appropriate. We believe this is a major weakness of the study protocol.
    Response: Assessment of untreated indications is clearly one type 
of DRP that will be assessed as part of this study. Follow-up 
recommendations will be provided to prescribers.
    Comment d: Of the five interventions identified in the study 
protocol, several fall outside the purview of a pharmacist's 
traditional training such as scheduling follow-up doctor's 
appointments, obtaining transportation to the clinic or motivating 
patients to take their medications using motivational interviewing 
techniques. We are concerned about the feasibility and cost of training 
pharmacists to undertake these tasks.
    Response: The purpose for this study is to assess components of 
MTM. Providers of MTM may include pharmacists or other healthcare 
professionals. Thus, a ``pharmacist's traditional training'' is not 
necessarily relevant to the design of the intervention. Nevertheless, 
as mentioned above, the intervention has been revised to focus on 
medication reconciliation and DAP assessment--two activities which are 
likely within the purview of most pharmacists.
    Comment e: What is the method of that will be used to achieve an 
equal or roughly proportional number of enrollees in each group?
    Response: Stratified randomization.
    Comment f: Similarly, how is the site effect controlled for, 
particularly since a disproportionate number of subjects may be 
enrolled at the University of Illinois at Chicago site (100 patients)?
    Response: There will be an equal number of subjects enrolled at 
each site.
    Comment g: How will be the investigators account for failure to 
enroll beneficiaries in either group?
    Response: Each study site draws from a large pool of eligible 
participants and includes experienced investigators who have 
successfully recruited patients for similar types of studies. Given the 
relatively low burden for participation, the study is anticipated to 
enroll an

[[Page 28055]]

adequate sample. However, should the initial recruitment efforts be 
unsuccessful we will intensify efforts by contacting physicians to 
refer patients, posting advertisements, and screening patients seen in 
applicable clinics. Also, if failure to enroll at one site is a problem 
we can increase enrollment at other sites to compensate.
    Comment h: Presumably, participants in the control group will be 
receiving some level of MTM by virtue of Part D enrollment. How will 
``usual care'', which could contain widely variable applications of 
MTM, be defined, measured, controlled, and distinguished from the 
``intervention''?
    Response: Patients already enrolled in an MTM program where 
medication reconciliation and/or assessment of DRPs has occurred in the 
previous 12 months will be excluded.
    Comment i: What methodology will be employed to control for 
potential confounders residing with the pharmacist; for example, 
pharmacist tenure/experience with MTM service?
    Response: There will be a small number of pharmacists at each site 
(1 or 2) and all of the pharmacists will be of similar tenure/
experience. Training will be provided to all pharmacists so that the 
protocol is implemented in a standard manner.
    Comment j: How will non-adherence to scheduled monthly MTM program 
visits and subsequent missing data be accounted for? Will this be a 
last-observation-carried-forward study? Will beneficiaries who do not 
keep appointments for some percentage of their scheduled follow-up 
visits be excluded or treated as controls? Is there a procedure for 
identifying why patients leave the study?
    Response: The intervention has been changed from monthly visits to 
just 2 visits. With this reduced number of visits we do not anticipate 
significant non-compliance. An intent-to-treat analysis will be 
conducted, meaning that the analysis will be based on the group to 
which subjects were originally/randomly assigned.
    Comment k: Will pharmacists evaluate all of the beneficiary's 
medications or just those that are Part D covered? Presumably, one 
would assume the former; however, this should be explicitly stated. And 
again, how does this differ from ``usual care''? Likewise, how will 
non-Part D medications, particularly samples and OTC medications, be 
accounted for regarding medication adherence (patient self-report, 
pharmacy claims, both)?
    Response: The program will evaluate all medications. Medication 
adherence has been removed as an outcome measure for the study.
    Comment l: It seems unlikely that when assessed for 12-month recall 
of adverse events at the close of the study, participants will be able 
to relate an accurate history. A participant log or dairy might support 
recall of events.
    Response: The protocol has been changed and we will now assess this 
at day 90 and 180 for only the preceding 3 months, using a structured 
interview. In order to assist with recall, we will provide participants 
with a patient log or diary to record drug related problems.
    Comment m: We believe that the investigators may have 
underestimated the time required to collect information from study 
participants and to abstract data from clinical records, particularly 
given the number of tools and measurements that will be employed. 
Additionally, there appears to be no formal training of pharmacists in 
the utilization and application of these instruments, which may further 
underestimate burden.
    Response: Significant changes have now been made to reduce the 
patient and investigator time. A formal training session will be held 
for pharmacists who will provide the intervention and tools have been 
developed to standardize the intervention as mentioned above.
    Comment n: As we have communicated in the list of questions/
concerns about design (above), we believe that the study could be 
strengthened by clearer definitions of the intervention ``MTM program'' 
and the ``dose'' (that is, the specific type and amount of services 
that the treating pharmacist elects to provide a given beneficiary). If 
doses are not standard across beneficiaries, as one would expect, what 
characteristics/criteria will be used to determine dose?
    Response: The revised protocol may contain more data upon which to 
assess these issues. The intervention has been more clearly defined and 
narrowed in scope, and the number of visits has been reduced.
    Comment o: The study could be strengthened by explication of 
techniques for accrual, randomization, and follow up on missed 
appointments and handling of missing data.
    Response: All of these items are included in the revised protocol.
    Comment p: While we strongly favor and actively use electronic 
clinical records for MTM, we have found that automated data collection 
techniques (such as interactive voice response, or IVR) are frequently 
impractical for collecting data from older adults who may have 
difficulty hearing, need more time to respond than is typically 
programmed, and need to have items repeated. However, data collection 
via telephone with a ``live'' data collector and web-enabled medication 
management devices that also track adherence and present questions/
collect information from patients are potentially very useful in terms 
of data accuracy and completeness. One caution exists in terms of 
interpretation and generalizability of the findings: Automated data 
collection techniques might ``cue'' the beneficiary in a way that 
inflates the effect; as such, cues would presumably not be present in 
standard (non-experimental) application of MTM programs. This could 
lead to inflation of effect and potential Type 1 error. Studies are 
needed that explore the feasibility and utility of automated data 
collection with older adults who are at risk for medication-related 
problems and poor outcomes.
    Response: This study uses no automated collection techniques.
    Comment q: ACCP recommends that inclusion of additional survey 
questions that would investigate the process by which beneficiaries are 
being informed and educated about the availability of MTMPs for 
eligible enrollees, and how the plans are promoting MTMPs among their 
enrollees.
    Response: The purpose of the proposed study is to evaluate a 
specific MTM intervention. While important questions, a survey of MTM 
providers about the process by which beneficiaries are being informed 
and educated about the availability of MTMPs for eligible enrollees, 
and how the plans are promoting MTMPs among their enrollees is not 
within the scope of the study.
    Comment r: We strongly believe that any research in the area of 
MTMP will be very helpful in determining the effect of these programs, 
but it appears in the proposed project that community pharmacy sites 
are being excluded from the study. Community pharmacy must be 
represented in any study evaluating the effectiveness of MTMP, so as to 
determine potential strengths and/or barriers to providing these 
programs in the community pharmacy setting. We question the broad 
applicability of this research project based on the sites from which 
study subjects will be recruited and we strongly encourage the 
involvement of community pharmacy practice sites in this project.
    Response: AHRQ recognizes the importance of community pharmacy as 
one site in which MTM may be provided. No study can be designed to 
include all aspects of diversity in the site of provision of MTM. For 
this study

[[Page 28056]]

we attempted to obtain a balance between availability of data needed to 
assess the impact of the intervention, and the generalizability of the 
setting of care. In revisions made to the protocol we have focused on 
developing an intervention that could be conducted in a community 
pharmacy, and as such may be generalizable to community pharmacies.

    Dated: May 10, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07-2481 Filed 5-17-07; 8:45 am]
BILLING CODE 4160-90-M


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