[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 <a href="/cdn-cgi/l/email-protection#fab5b3a8bba5898f9897938989939594ba959798d49f958ad49d958c"><span class="__cf_email__" data-cfemail="2867617a69775b5d4a45415b5b4147466847454a064d4758064f475e">[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 the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by e-mail at 
<a href="/cdn-cgi/l/email-protection#284c475a415b06444d4e43475f415c526849405a4f0640405b064f475e"><span class="__cf_email__" data-cfemail="b7d3d8c5dec499dbd2d1dcd8c0dec3cdf7d6dfc5d099dfdfc499d0d8c1">[email protected]</span></a>.

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                  organizations*   organization      response          hours
----------------------------------------------------------------------------------------------------------------
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........................................
                                                 ---------------------------------------------------------------
    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 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                     organizations*       hours        wage rate**       burden
----------------------------------------------------------------------------------------------------------------
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........................................
                                                 ---------------------------------------------------------------
    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 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
------------------------------------------------------------------------
                                                            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 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


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