Federal Register: September 1, 2009 (Volume 74, Number 168)
DOCID: fr01se09-64 FR Doc E9-20854
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
NOTICE: NOTICES
DOCID: fr01se09-64
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY:
Agency Information Collection Activities: Proposed Collection; Comment Request
DATES: Comments on this notice must be received by October 1, 2009.
DOCUMENT 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.
SUMMARY:
Agency Information Collection Activities; Proposals, Submissions, and Approvals
SUPPLEMENTAL INFORMATION
Proposed Project
Health IT Community Tracking Study 2009
Electronic prescribing (eprescribing) 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 eprescribing, 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 110275, authorized a new
incentive program for eligible individual providers who are successful
eprescribers. In addition, Section 4101 of the American Recovery and
Reinvestment Act of 2009 (ARRA), Public Law 1115, provides incentives
for meaningful use of electronic health record technology, which includes the use of eprescribing.
The potential gains from eprescribing assume that prescribers and pharmacists have access to the required features and use them. Limited research on the topic suggests, however, that not all eprescribing systems currently have the full range of eprescribing 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 eprescribing 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 mid1990s 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 eprescribing. 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 eprescribing 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 eprescribing.
Information collected by this study will inform strategies to promote the adoption and effective use of eprescribing 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 eprescribing in retail and mailorder pharmacies. This work will be conducted by AHRQ's contractor, the Center for Studying Health System Change (HSC), under contract number 29005000703. 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 eprescribing experts.
Using semistructured interview protocols, the following specific
research questions will be addressed to provide an indepth look at
unexplored barriers to effective eprescribing use in physician practices and pharmacies, including:
[ballot] How are physicians using thirdparty information in making
prescribing decisions, including patient medication history, generic drug information, and patientspecific formulary data?
[ballot] How are physician practices and retail and mailorder
pharmacies using eprescribing 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 eprescribing systems (regardless of how they were sent)?
[ballot] What are the facilitators of and challenges to
implementing eprescribing features that support physician access to
thirdparty 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 thirdparty
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 physicianuser best able to describe practice processes for eprescribing, 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 organizationspecific 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.
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Exhibit 1Estimated Annualized Burden Hours
Number of
Form name Number of responses per Hours per Total burden
organizations* organization response hours
Interview Protocol 1Physician Practice IT 12 1 30/60 6 administrator or Office Manager................
Interview Protocol 2Physician Practice Medical 12 1 45/60 9 Director or Physician User.....................
Interview Protocol 3Pharmacy PharmacistIn 28 1 1 28 Charge.........................................
Interview Protocol 4State Pharmacy Association 6 1 1 6 Representative.................................
Interview Protocol 5Pharmacy IT Vendor 1 1 1 1 Representative.................................
Interview Protocol 6Eprescribing System 3 1 1 3 Vendor Representative..........................
Interview Protocol 7Eprescribing Connectivity 1 3 3 1 and Content Vendor Representatives.............
Interview Protocol 8Other Eprescribing 2 1 30/60 1 Experts........................................
Total....................................... 67 NA NA 57
* 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 2Estimated Annualized Cost Burden
Number of Total burden Average hourly Total cost
Form name organizations* hours wage rate** burden
Interview Protocol 1Physician Practice IT 12 6 $32.62 $196 Administrator or Office Manager................
Interview Protocol 2Physician Practice Medical 12 9 80.42 724 Director or Physician User.....................
Interview Protocol 3Pharmacy PharmacistIn 28 28 48.09 1,347 Charge.........................................
Interview Protocol 4State Pharmacy Association 6 6 49.89 299 Representative.................................
Interview Protocol 5Pharmacy IT Vendor 1 1 54.75 55 Representative.................................
Interview Protocol 6Eprescribing System 3 3 54.75 164 Vendor Representative..........................
Interview Protocol 7Eprescribing Connectivity 3 3 54.75 164 and Content Vendor Representatives.............
Interview Protocol 8Other Eprescribing 2 1 54.75 55 Experts........................................
Total....................................... 67 57 NA 3,004 * 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 3Pharmacy PharmacistInCharge 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 twoyear 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 3Estimated Total and Annual Cost* to the Federal Government
Annualized
Cost component Total cost cost
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
Total............................... 374,635 187,318 * Costs are fully loaded including overhead and G&A.
Request for Comments
In accordance with the abovecited 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
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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. E920854 Filed 83109; 8:45 am]
BILLING CODE 416090M
FOR FURTHER INFORMATION CONTACT
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 4271477, or by email at
doris.lefkowitz@ahrg.hhs.gov.