Scientific Information Request on Public Reporting of Cost Measures in Health, 7456-7457 [2014-02170]
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Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Notices
OS specifically requests comments on
(1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Darius Taylor,
Deputy, Information Collection Clearance
Officer.
[FR Doc. 2014–02641 Filed 2–6–14; 8:45 am]
BILLING CODE 4168–11–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Scientific Information Request on
Public Reporting of Cost Measures in
Health
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for scientific
information submissions.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public on public reporting of cost
measures in health. Scientific
information is being solicited to inform
our technical brief on Public Reporting
of Cost Measures in Health, which is
currently being conducted by the
Evidence-based Practice Centers for the
AHRQ Effective Health Care Program.
Access to published and unpublished
pertinent scientific information on
public reporting of cost measures in
health will improve the quality of this
technical brief. AHRQ is conducting this
technical brief pursuant to Section 1013
of the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, Public Law 108–173, and Section
902(a) of the Public Health Service Act,
42 U.S.C. 299a(a).
DATES: Submission Deadline on or
before March 10, 2014.
ADDRESSES:
Online submissions: https://
effectivehealthcare.AHRQ.gov/
index.cfm/submit-scientificinformation-packets/. Please select the
study for which you are submitting
information from the list to upload your
documents.
Email submissions: SIPS@epc-src.org.
Print submissions:
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SUMMARY:
VerDate Mar<15>2010
17:17 Feb 06, 2014
Jkt 232001
Mailing Address: Portland VA
Research Foundation, Scientific
Resource Center, ATTN: Scientific
Information Packet Coordinator, PO Box
69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.):
Portland VA Research Foundation,
Scientific Resource Center, ATTN:
Scientific Information Packet
Coordinator, 3710 SW U.S. Veterans
Hospital Road, Mail Code: R&D 71,
Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT:
Robin Paynter, Research Librarian,
Telephone: 503–220–8262 ext. 58652 or
Email: SIPS@epc-src.org.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the Effective
Health Care (EHC) Program Evidencebased Practice Centers to complete a
technical brief of the evidence for Public
Reporting of Cost Measures in Health.
The EHC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its technical briefs. In order to
do so, we are supplementing the usual
manual and electronic database searches
of the literature by requesting
information from the public (e.g., details
of studies conducted). We are looking
for studies that report on public
reporting of cost measures in health,
including those that describe adverse
events. The entire research protocol,
including the key questions, is also
available online at: https://
effectivehealthcare.AHRQ.gov/ehc/
products/562/1838/public-reportingcost-measures-protocol-140113.pdf
This notice is to notify the public that
the EHC program would find the
following information on public
reporting of cost measures in health
helpful:
D A list of completed studies your
organization has sponsored for this
indication. In the list, indicate whether
results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements: Study number, study period,
design, methodology, indication and
diagnosis, proper use instructions,
inclusion and exclusion criteria,
primary and secondary outcomes,
baseline characteristics, number of
patients screened/eligible/enrolled/lost
to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
• A list of ongoing studies your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the Program. The contents of all
submissions will be made available to
the public upon request. Materials
submitted must be publicly available or
can be made public. Materials that are
considered confidential; marketing
materials; study types not included in
the review; or information on
indications not included in the review
cannot be used by the Effective Health
Care Program. This is a voluntary
request for information and all costs for
complying with this request must be
borne by the submitter.
The draft of this review will be posted
on AHRQ’s EHC program Web site and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://effectivehealthcare.AHRQ.gov/
index.cfm/join-the-email-list1/.
The technical brief will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions. The entire
research protocol, is also available
online at: https://
effectivehealthcare.AHRQ.gov/ehc/
products/562/1838/public-reportingcost-measures-protocol-140113.pdf
1. What measures of costs about
healthcare providers and facilities have
been publicly reported?
a. Who produces these reports and
where are they available?
b. For what facilities are costs
reported?
c. At what level are these data
aggregated (e.g. provider, facility, etc.)?
d. How are the cost data reported (e.g.,
dollar amounts, symbols, graphs etc.)?
e. How are the costs of providers/
facilities compared (e.g., how many
facilities, regional verses national
comparisons etc.)?
2. Are the measures of costs that are
being reported consumer centered?
a. How are consumers instructed to
use the data?
b. What techniques are used to guide
consumers to interpret the data
appropriately?
E:\FR\FM\07FEN1.SGM
07FEN1
7457
Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Notices
c. Is there evidence that the data is
used by consumers?
d. Is the data relevant to consumers
making healthcare decisions?
e. Is the data easily accessible and
presented in a consumer friendly way?
3. What are the intended and
unintended consequences of consumers’
use of public-reported cost data?
a. Do consumers find the public
reporting of cost measures relevant and
are consumers satisfied with the
experience?
b. Does the public reporting of cost
measures impact (or have the potential
to impact) consumers’ decisions or
behaviors?
c. What are the potential unintended
consequences of public reporting of cost
measures?
d. Are there key research gaps and
needs for future research?
Dated: January 24, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–02170 Filed 2–6–14; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–14–13AGH]
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 (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Examining Traumatic Brain Injury in
Youth—New—National Center for
Injury Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Traumatic brain injury (TBI) is one of
the highest priorities in public health
because of its magnitude, economic and
human impact, and preventability. The
Centers for Disease Control and
Prevention (CDC) estimates that
approximately 1.7 million TBIs are
sustained in the United States annually,
either alone or in conjunction with
another injury or condition. These
figures may be an underestimation as
they do not include people who are
treated in physicians’ offices or
outpatient facilities, those who did not
seek medical care, military personnel, or
Americans living abroad. Moreover, the
number of sports and recreation-related
TBIs treated in U.S. emergency
departments is increasing and has
increased steadily since the early 2000s.
Children ages 0 to 4 years and
adolescents ages 15–19 are at the
greatest risk of sustaining a TBI.
A TBI is caused by a bump, blow or
jolt to the head or a penetrating head
injury that disrupts the normal function
of the brain. The severity of a TBI may
range from ‘‘mild’’ (a brief change in
mental status or consciousness) to
‘‘severe’’ (an extended period of
unconsciousness or amnesia after the
injury).
In 1996, Congress passed Public Law
104–166, the Traumatic Brain Injury
Act, which charged CDC with
implementing projects to reduce the
incidence of traumatic brain injury. The
CDC definition of TBI uses selected
codes of the International Classification
of Diseases, 9th Clinical Modification
(ICD–9 CM) to identify cases of TBI from
hospital and non-hospital databases
containing billing records for services
rendered to patients. It is thought,
however, that the ICD–9 CM codes
currently used in CDC’s surveillance
system to capture cases of TBI are not
sufficiently sensitive to capture
diagnosed TBI.
CDC requests OMB approval for one
year to collect de-identified medical
information of a representative sample
of pediatric patients, from two clinical
settings, who received a confirmed
diagnosis of mild to severe TBI and link
these patients to their administrative
medical claims forms. Collectively, the
data will allow CDC to estimate the
sensitivity of currently utilized ICD–9
CM codes to capture cases of diagnosed
TBI, as well as ICD–9 CM codes not
currently being utilized that may
improve the sensitivity to capture cases
of TBI. We propose to conduct a
retrospective cross-sectional study of a
random sample of patients with a
suspected TBI within two clinical
settings (Emergency Departments and
Concussion Clinics).
A review of the medical coding data
for additional ICD–9 CM codes that are
not part of the CDC TBI definition will
also take place to determine whether the
addition of any of these codes improves
the sensitivity of the CDC TBI definition
to detect TBI.
The Emergency Department medical
records of 150 patients will be
abstracted in order to review ICD–9
codes and TBI diagnoses. Each record
will take 60 minutes to abstract. Also,
50 patient medical records from the
Concussion Clinic, located within the
hospital, will be abstracted in order to
review the selection criteria to confirm
eligibility, which includes age of the
patient, and the valid encounter with
physician or nurse related to an injury
consistent with a TBI. Each record will
take 60 minutes to abstract. The same
Research Assistant will be abstracting
the data within the Emergency
Department and the Concussion Clinic.
There are no costs to respondents
other than their time. The total
estimated annual burden hours are 200.
ESTIMATED ANNUALIZED BURDEN HOURS
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Type of
respondent
Form name
Emergency Department Research Assistant ..
Concussion Clinic Research Assistant ...........
TBI Records Data Tool ..................................
TBI Records Data Tool ..................................
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Number of
responses per
respondent
Number of
respondents
E:\FR\FM\07FEN1.SGM
1
1
07FEN1
150
50
Average
burden per
response
(in hrs.)
1
1
]]>Agencies
[Federal Register Volume 79, Number 26 (Friday, February 7, 2014)]
[Notices]
[Pages 7456-7457]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02170]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Scientific Information Request on Public Reporting of Cost
Measures in Health
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for scientific information submissions.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public on public
reporting of cost measures in health. Scientific information is being
solicited to inform our technical brief on Public Reporting of Cost
Measures in Health, which is currently being conducted by the Evidence-
based Practice Centers for the AHRQ Effective Health Care Program.
Access to published and unpublished pertinent scientific information on
public reporting of cost measures in health will improve the quality of
this technical brief. AHRQ is conducting this technical brief pursuant
to Section 1013 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, Public Law 108-173, and Section 902(a) of
the Public Health Service Act, 42 U.S.C. 299a(a).
DATES: Submission Deadline on or before March 10, 2014.
ADDRESSES:
Online submissions: https://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the study for
which you are submitting information from the list to upload your
documents.
Email submissions: src.org">SIPS@epc-src.org.
Print submissions:
Mailing Address: Portland VA Research Foundation, Scientific
Resource Center, ATTN: Scientific Information Packet Coordinator, PO
Box 69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.): Portland VA Research
Foundation, Scientific Resource Center, ATTN: Scientific Information
Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D
71, Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian,
Telephone: 503-220-8262 ext. 58652 or Email: src.org">SIPS@epc-src.org.
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Effective Health Care (EHC) Program
Evidence-based Practice Centers to complete a technical brief of the
evidence for Public Reporting of Cost Measures in Health.
The EHC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its technical
briefs. In order to do so, we are supplementing the usual manual and
electronic database searches of the literature by requesting
information from the public (e.g., details of studies conducted). We
are looking for studies that report on public reporting of cost
measures in health, including those that describe adverse events. The
entire research protocol, including the key questions, is also
available online at: https://effectivehealthcare.AHRQ.gov/ehc/products/562/1838/public-reporting-cost-measures-protocol-140113.pdf
This notice is to notify the public that the EHC program would find
the following information on public reporting of cost measures in
health helpful:
[ssquf] A list of completed studies your organization has sponsored
for this indication. In the list, indicate whether results are
available on ClinicalTrials.gov along with the ClinicalTrials.gov trial
number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements: Study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
A list of ongoing studies your organization has sponsored
for this indication. In the list, please provide the ClinicalTrials.gov
trial number or, if the trial is not registered, the protocol for the
study including a study number, the study period, design, methodology,
indication and diagnosis, proper use instructions, inclusion and
exclusion criteria, and primary and secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. The contents
of all submissions will be made available to the public upon request.
Materials submitted must be publicly available or can be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on indications not
included in the review cannot be used by the Effective Health Care
Program. This is a voluntary request for information and all costs for
complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EHC program Web
site and available for public comment for a period of 4 weeks. If you
would like to be notified when the draft is posted, please sign up for
the email list at: https://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.
The technical brief will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions. The entire research
protocol, is also available online at: https://effectivehealthcare.AHRQ.gov/ehc/products/562/1838/public-reporting-cost-measures-protocol-140113.pdf
1. What measures of costs about healthcare providers and facilities
have been publicly reported?
a. Who produces these reports and where are they available?
b. For what facilities are costs reported?
c. At what level are these data aggregated (e.g. provider,
facility, etc.)?
d. How are the cost data reported (e.g., dollar amounts, symbols,
graphs etc.)?
e. How are the costs of providers/facilities compared (e.g., how
many facilities, regional verses national comparisons etc.)?
2. Are the measures of costs that are being reported consumer
centered?
a. How are consumers instructed to use the data?
b. What techniques are used to guide consumers to interpret the
data appropriately?
[[Page 7457]]
c. Is there evidence that the data is used by consumers?
d. Is the data relevant to consumers making healthcare decisions?
e. Is the data easily accessible and presented in a consumer
friendly way?
3. What are the intended and unintended consequences of consumers'
use of public-reported cost data?
a. Do consumers find the public reporting of cost measures relevant
and are consumers satisfied with the experience?
b. Does the public reporting of cost measures impact (or have the
potential to impact) consumers' decisions or behaviors?
c. What are the potential unintended consequences of public
reporting of cost measures?
d. Are there key research gaps and needs for future research?
Dated: January 24, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-02170 Filed 2-6-14; 8:45 am]
BILLING CODE 4160-90-P
