[Federal Register Volume 74, Number 168 (Tuesday, September 1, 2009)]
[Notices]
[Pages 45211-45214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20854]
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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, HHS.
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) approve the proposed information collection
project: ``Health IT Community Tracking Study 2009.'' In accordance
with the Paperwork Reduction Act of 1995, 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 June 30th, 2009 and allowed 60 days for public
comment. No comments were received. The purpose of this notice is to
allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by October 1, 2009.
ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by
e-mail at [email protected] (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 the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by e-mail at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Health IT Community Tracking Study 2009
Electronic prescribing (e-prescribing) is a central focus of
efforts to promote health information technology (IT) and is of
particular interest to AHRQ because of its potential to improve patient
safety by reducing medication errors. Despite many public- and private-
sector initiatives to support e-prescribing, to date, physician
adoption and use has been limited (Friedman, Schueth and Bell 2009).
Recently, Section 132 of the Medicare Improvements for Patients and
[[Page 45212]]
Providers Act of 2008 (MIPPA), Public Law 110-275, authorized a new
incentive program for eligible individual providers who are successful
e-prescribers. In addition, Section 4101 of the American Recovery and
Reinvestment Act of 2009 (ARRA), Public Law 111-5, provides incentives
for meaningful use of electronic health record technology, which
includes the use of e-prescribing.
The potential gains from e-prescribing assume that prescribers and
pharmacists have access to the required features and use them. Limited
research on the topic suggests, however, that not all e-prescribing
systems currently have the full range of e-prescribing features
required under MIPPA; that even when the features are available,
physician practices face barriers to implementing them effectively; and
even when they are implemented at the practice level, physicians may
not use them. For example, in a small, exploratory qualitative study by
Grossman, et al. (2005), physicians did not routinely have access to
patient medication histories or formulary data for a significant
portion of their patients and when they did, physicians often did not
use the information, instead continuing to rely on patients for
medication history and pharmacists to identify formulary issues.
Several studies have identified that IT system limitations, workflow
and training issues, and real or perceived regulatory barriers present
obstacles in both the physician and pharmacy settings to electronic
transmission of prescriptions (Grossman et al. 2007; NORC 2007; Rupp
and Warholak 2008; Warholak and Rupp 2009).
AHRQ proposes to conduct a qualitative research study designed to
help build knowledge on how the e-prescribing features required under
MIPPA are actually being implemented and used by physicians and
pharmacies in 12 nationally representative communities. These
communities have been studied longitudinally since the mid-1990s as
part of the Center for Studying Health System Change (HSC) Community
Tracking Study (CTS) (Center for Studying Health System Change 2007).
This qualitative study will collect data from physician practices and
pharmacies that are using electronic transmission of prescriptions to
allow a focus on both the facilitators of and barriers to this critical
aspect of e-prescribing. The study will be the first to ask questions
of physician practices and pharmacies in the same communities on the
same topics, providing a much more complete picture of e-prescribing
implementation. For example, in addition to gaining physician and
pharmacy perspectives on electronic transmission, the study will
explore how physician practices use patient formulary data and how
pharmacies perceive changes in the communication with physician
practices around formulary issues with e-prescribing.
Information collected by this study will inform strategies to
promote the adoption and effective use of e-prescribing being developed
by AHRQ and other Department of Health and Human Services agencies,
including the Centers for Medicare & Medicaid Services (CMS) and the
Office of the National Coordinator for Health IT, as well as State and
local governments and private health care organizations. In particular,
while physician adoption has been the focus of most policy efforts,
findings from the study can help identify and shape strategies to
promote more effective implementation of e-prescribing in retail and
mail-order pharmacies. This work will be conducted by AHRQ's
contractor, the Center for Studying Health System Change (HSC), under
contract number 290-05-0007-03. This study is being conducted pursuant
to AHRQ's statutory authority to conduct and support research on health
care and systems for the delivery of such care, including activities
with respect to health care technologies, facilities and equipment, 42
U.S.C. 299a(a)(5).
Method of Collection
The study will use qualitative methods, including telephone
interviews with physician practices and pharmacies, as well as State
pharmacy associations, IT vendors and other e-prescribing experts.
Using semi-structured interview protocols, the following specific
research questions will be addressed to provide an in-depth look at
unexplored barriers to effective e-prescribing use in physician
practices and pharmacies, including:
[ballot] How are physicians using third-party information in making
prescribing decisions, including patient medication history, generic
drug information, and patient-specific formulary data?
[ballot] How are physician practices and retail and mail-order
pharmacies using e-prescribing systems to communicate electronically
with each other?
[ballot] What are the most common reasons that physician practices
and pharmacies communicate about prescriptions generated by physician
e-prescribing systems (regardless of how they were sent)?
[ballot] What are the facilitators of and challenges to
implementing e-prescribing features that support physician access to
third-party information in making prescribing decisions and features
that support electronic communication between physician practices and
pharmacies?
[ballot] What are the perceived effects of having access to e-
prescribing features that support physician access to third-party
information in making prescribing decisions and features that support
electronic communication between physician practices and pharmacies on
physician practice and pharmacy operations, physician prescribing
behavior and patient outcomes?
[ballot] What are the implications for policy efforts to promote e-
prescribing?
Estimated Annual Respondent Burden
Interviews will be conducted at a total of 110 organizations over
the two years of this project. Within each of the 24 participating
physician practices (12 annually), two interviews will be conducted:
One with the medical director or physician-user best able to describe
practice processes for e-prescribing, who will provide a clinical
perspective (Interview Protocol 2), and a second with an IT
administrator or office manager, who can provide a technical and
operational perspective (Interview Protocol 1). The other 86
organizations will each have only one interview, for a total of 43
additional interviews annually. Eight different organization-specific
interview protocols have been developed, with response times ranging
from 30 minutes to 1 hour.
Exhibit 1 shows the estimated annual burden hours for each
organization's time to participate in this research. The total annual
burden is estimated to be 57 hours.
Exhibit 2 shows the estimated annual cost burden associated with
the organizations' time to participate in this research. The total
annual burden is estimated to be $3,004.
[[Page 45213]]
Exhibit 1--Estimated Annualized Burden Hours
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Number of
Form name Number of responses per Hours per Total burden
organizations* organization response hours
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Interview Protocol 1--Physician Practice IT 12 1 30/60 6
administrator or Office Manager................
Interview Protocol 2--Physician Practice Medical 12 1 45/60 9
Director or Physician User.....................
Interview Protocol 3--Pharmacy Pharmacist-In- 28 1 1 28
Charge.........................................
Interview Protocol 4--State Pharmacy Association 6 1 1 6
Representative.................................
Interview Protocol 5--Pharmacy IT Vendor 1 1 1 1
Representative.................................
Interview Protocol 6--E-prescribing System 3 1 1 3
Vendor Representative..........................
Interview Protocol 7--E-prescribing Connectivity 1 3 3 1
and Content Vendor Representatives.............
Interview Protocol 8--Other E-prescribing 2 1 30/60 1
Experts........................................
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Total....................................... 67 NA NA 57
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* The estimated total number of unique organizations participating in each year of the study is 55 since
Interview Protocols 1 and 2 will both be administered to respondents in physician practices.
Exhibit 2--Estimated Annualized Cost Burden
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Number of Total burden Average hourly Total cost
Form name organizations* hours wage rate** burden
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Interview Protocol 1--Physician Practice IT 12 6 $32.62 $196
Administrator or Office Manager................
Interview Protocol 2--Physician Practice Medical 12 9 80.42 724
Director or Physician User.....................
Interview Protocol 3--Pharmacy Pharmacist-In- 28 28 48.09 1,347
Charge.........................................
Interview Protocol 4--State Pharmacy Association 6 6 49.89 299
Representative.................................
Interview Protocol 5--Pharmacy IT Vendor 1 1 54.75 55
Representative.................................
Interview Protocol 6--E-prescribing System 3 3 54.75 164
Vendor Representative..........................
Interview Protocol 7--E-prescribing Connectivity 3 3 54.75 164
and Content Vendor Representatives.............
Interview Protocol 8--Other E-prescribing 2 1 54.75 55
Experts........................................
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Total....................................... 67 57 NA 3,004
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* The estimated total number of unique organizations participating in each year of the study is 55 since
Interview Protocols 1 and 2 will both be administered to respondents in physician practices.
** Wage rates were calculated using the mean hourly wage from the U.S. Department of Labor, Bureau of Labor
Statistics, May 2007 National Occupational Employment and Wage Estimates for the United States, Occupational
Employment Statistics (OES), Washington, DC (Feb. 2009), http://www.bls.gov/oes/2007/may/oes_nat.htm
(accessed April 2009). Wage rate for Interview Protocol 3--Pharmacy Pharmacist-In-Charge reflects the weighted
average for retail and mail order pharmacists ($47.58 per hour) and pharmacy chain representatives ($54.75 per
hour).
Estimated Annual Costs to the Federal Government
The estimated total cost to the Federal Government for this project
is $374,635 over a two-year period from February 2, 2009 to February 1,
2010. The estimated average annual cost is $187,318. Exhibit 3 provides
a breakdown of the estimated total and average annual costs by
category.
Exhibit 3--Estimated Total and Annual Cost* to the Federal Government
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Annualized
Cost component Total cost cost
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Project Development and Project $87,783 $43,892
Management.............................
Data Collection Activities.............. 141,048 70,524
Data Analysis........................... 55,884 27,942
Publication and Dissemination of Results 89,920 44,960
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Total............................... 374,635 187,318
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* Costs are fully loaded including overhead and G&A.
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
AHRQ health care research, quality improvement and information
dissemination functions, 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 Agency's subsequent
[[Page 45214]]
request for OMB approval of the proposed information collection. All
comments will become a matter of public record.
Dated: August 19, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9-20854 Filed 8-31-09; 8:45 am]
BILLING CODE 4160-90-M