Agency Information Collection Activities: Proposed Collection; Comment Request, 45211-45214 [E9-20854]
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Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices
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(E) Annual Re-Certification by
Children’s Hospitals To Maintain
Eligibility Status in 340B Drug Pricing
Program
Children’s hospitals have an ongoing
responsibility to immediately notify
OPA in the event of any change in
eligibility for the 340B Drug Pricing
Program. No less than on an annual
basis, children’s hospitals will need to
demonstrate continued maintenance of
the required disproportionate share
adjustment percentage or
disproportionate patient percentage.
OPA will provide additional guidance
as it gains experience and develops its
plans to annually certify covered
entities. To the extent that OPA is able
to obtain periodic documentation of
such data similar to that provided by
CMS with respect to DSHs, it may notify
the covered entity that such information
need not be provided.
(F) Eligibility for Discounts Back to
February 8, 2006
Section 6004 of the DRA indicates
that the amendment authorizing entry of
children’s hospitals into the 340B
Program ‘‘shall apply to drugs
purchased on or after the date of the
enactment of this Act.’’ The DRA
provision was enacted on February 8,
2006. Therefore, once children’s
hospitals are admitted to the 340B
Program and listed on the Covered
Entity Database, they are eligible for
340B drug pricing back to February 8,
2006. However, a children’s hospital
will be eligible for such retroactive
discounts only to the extent that it has
satisfied all requirements for
participation in the 340B program back
to the date discounts are requested.
Children’s hospitals may request
retroactive discounts (discounts,
rebates, or account credit) directly from
pharmaceutical manufacturers for
covered outpatient drugs when all the
following conditions are satisfied:
(1) The children’s hospital is listed on
the 340B Covered Entity Database as
eligible to purchase under 340B within
one year of publication of this notice.
(2) The children’s hospital sent a
request in writing to each manufacturer
of the drug(s) for which retroactive
discounts are sought within 30 days of
the children’s hospital having been
listed as eligible to purchase under 340B
on the 340B Covered Entity Database;
(3) The covered outpatient drugs must
have been purchased on or after
February 8, 2006;
(4) The covered outpatient drugs must
not have generated Medicaid rebates
(the children’s hospital must have
appropriate documentation to
demonstrate this);
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(5) The covered outpatient drugs must
not have been sold or transferred to a
person who was not a patient of the
children’s hospital; and
(6) The covered outpatient drugs must
have been purchased on or after the date
on which the children’s hospital
satisfied all requirements for
participation in the 340B Program as
outlined in section (D) of this notice.
In order to satisfy the last condition
listed above, a children’s hospital must
be able to demonstrate, at a minimum,
that as required by section
340B(a)(4)(L)(iii) of the Public Health
Service Act, the children’s hospital did
not have a group purchasing agreement
for covered outpatient drugs and
satisfied the requirements of section
340B(a)(4)(L)(i) and 340B(a)(4)(L)(ii) at
the time the covered outpatient drugs
for which rebates are requested were
purchased. Participation in a GPO for
any covered outpatient drugs would
disqualify a children’s hospital for
retroactive rebates during any quarter
that the children’s hospital purchased
any covered outpatient drug through a
GPO or other group purchasing
arrangement. Consistent with section
340B(a)(5)(C) of the Public Health
Service Act, children’s hospitals must
have auditable records that support
claims for retroactive discounts and
permit the Government or
manufacturers to audit those records (in
accordance with procedures established
by the Secretary relating to the number
scope and duration of such audits (61
FR 65406)).
In fulfilling the conditions listed
above, any children’s hospital that
believes it is entitled to retroactive
discounts may preserve its rights by
sending manufacturers a letter
requesting such refunds, explaining
how they meet the requirements in this
notice, and providing adequate
documentation of purchases within 30
days being listed on the 340B Covered
Entity Database as eligible. Such
children’s hospitals should engage in
good faith efforts to resolve any disputes
with manufacturers. To the extent they
are unable to resolve disputes and wish
to pursue further involvement with the
OPA, they are encouraged to follow the
guidance on the dispute resolution
process as described in the Federal
Register (61 FR 65406).
Dated: August 26, 2009.
Mary K. Wakefield,
Administrator.
[FR Doc. E9–21109 Filed 8–31–09; 8:45 am]
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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.
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 email at OIRA_submission@omb.eop.gov
(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 doris.lefkowitz@ahrg.hhs.gov.
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 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
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Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices
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 eprescribing 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 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
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
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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 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 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 eprescribing experts. Using semistructured 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:
b How are physicians using thirdparty information in making prescribing
decisions, including patient medication
history, generic drug information, and
patient-specific formulary data?
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b How are physician practices and
retail and mail-order pharmacies using
e-prescribing systems to communicate
electronically with each other?
b 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)?
b What are the facilitators of and
challenges to implementing eprescribing features that support
physician access to third-party
information in making prescribing
decisions and features that support
electronic communication between
physician practices and pharmacies?
b 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?
b 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 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
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.
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Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
organizations*
Number of responses per
organization
Hours per response
Interview Protocol 1—Physician Practice IT administrator or Office Manager
Interview Protocol 2—Physician Practice Medical Director or Physician User
Interview Protocol 3—Pharmacy Pharmacist-In-Charge .................................
Interview Protocol 4—State Pharmacy Association Representative ...............
Interview Protocol 5—Pharmacy IT Vendor Representative ...........................
Interview Protocol 6—E-prescribing System Vendor Representative .............
Interview Protocol 7—E-prescribing Connectivity and Content Vendor Representatives ..................................................................................................
Interview Protocol 8—Other E-prescribing Experts .........................................
12
12
28
6
1
3
1
1
1
1
1
1
30/60
45/60
1
1
1
1
6
9
28
6
1
3
1
2
3
1
3
30/60
1
1
Total ..........................................................................................................
67
NA
NA
57
Form name
Total burden
hours
* 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
organizations*
Form name
Total burden
hours
Average
hourly wage
rate**
Total cost
burden
Interview Protocol 1—Physician Practice IT Administrator or Office Manager
Interview Protocol 2—Physician Practice Medical Director or Physician User
Interview Protocol 3—Pharmacy Pharmacist-In-Charge .................................
Interview Protocol 4—State Pharmacy Association Representative ...............
Interview Protocol 5—Pharmacy IT Vendor Representative ...........................
Interview Protocol 6—E-prescribing System Vendor Representative .............
Interview Protocol 7—E-prescribing Connectivity and Content Vendor Representatives ..................................................................................................
Interview Protocol 8—Other E-prescribing Experts .........................................
12
12
28
6
1
3
6
9
28
6
1
3
$32.62
80.42
48.09
49.89
54.75
54.75
$196
724
1,347
299
55
164
3
2
3
1
54.75
54.75
164
55
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),
https://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
Cost component
Total cost
Annualized
cost
Project Development and Project Management ......................................................................................................
Data Collection Activities .........................................................................................................................................
Data Analysis ...........................................................................................................................................................
Publication and Dissemination of Results ...............................................................................................................
$87,783
141,048
55,884
89,920
$43,892
70,524
27,942
44,960
Total ..................................................................................................................................................................
374,635
187,318
* Costs are fully loaded including overhead and G&A.
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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
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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
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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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Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices
the NTCP’s four goal areas: (1) The
prevention of initiation of tobacco use
among young people, (2) the elimination
of nonsmokers’ exposure to secondhand
smoke, (3) the promotion of quitting
among adults and young people, and (4)
the elimination of tobacco-related
disparities.
In order to yield results that are
representative and comparable at both
national and state levels, information
will be collected from approximately
1,863 land-line telephone users in each
state and the District of Columbia. In
addition, a total of approximately 3,000
interviews will be conducted from a
national sample of cell phone users to
include the growing population of
households that rely exclusively on cell
phones. All interviews will be
conducted using computer-assisted
telephone interview (CATI)
methodology.
Survey results will be used to develop
estimates of tobacco use at the national
level by gender and race/ethnicity and
to evaluate comprehensive Tobacco
Control Programs. Study results will
have significant implications for the
development of policies and programs
aimed at preventing or reducing tobacco
use. There are no costs to respondents
except their time. The estimated
annualized burden hours are 38,303.
comments should be received within 30
days of this notice.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–09–09BU]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
Proposed Project
National Adult Tobacco Survey
(NATS)—New—Office on Smoking and
Health, National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Tobacco use remains the leading
preventable cause of disease and death
in the United States. Although the
prevalence of current smoking among
adults decreased significantly from 1998
to 2007 in 44 states, the District of
Columbia, and Puerto Rico, only one
State and one territory have met Healthy
People 2010 targets for reducing adult
smoking prevalence to 12%, and six
States have shown no substantial
changes in prevalence after controlling
for age, sex, and race/ethnicity.
CDC proposes to conduct the National
Adult Tobacco Survey (NATS) in 2009–
2010 to help evaluate and improve the
effectiveness of CDC’s National Tobacco
Control Program (NTCP). The NATS
will be a one-time, stratified, randomdigit dialed telephone survey of noninstitutionalized adults 18 years of age
and older. Essential information will be
collected on key indicators from each of
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Adults ages 18 or older ..........
Screener for land-line users (pp 11–18 of the NATS) ...........
Screener for cell phone users (pp 2–11 of the NATS) ..........
National Adult Tobacco Survey (pp 19–92 of the NATS)—
landline.
National Adult Tobacco Survey (pp 19–92 of the NATS)—
cell phone.
Dated: August 26, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–21043 Filed 8–31–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
[30Day-09–0730]
Centers for Disease Control and
Prevention
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Agency Forms Undergoing Paperwork;
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an
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Average
burden per
response
(in hours)
Number of respondents
Type of respondent
Sfmt 4703
Number of responses per
respondent
166,273
5,400
95,013
1
1
1
2/60
1/60
20/60
3,000
1
20/60
e-mail to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Evaluation of the Effectiveness of the
Smoke Alarm Installation and Fire
Safety Education (SAIFE) Program
[OMB No. 0920–0730 Exp. 9/30/2009]—
Extension—National Center for Injury
Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
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]]>Agencies
[Federal Register Volume 74, Number 168 (Tuesday, September 1, 2009)]
[Notices]
[Pages 45211-45214]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20854]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 OIRA_submission@omb.eop.gov (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
doris.lefkowitz@ahrg.hhs.gov.
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), https://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
