[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Notices]
[Page 34155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Measures for Primary 
Healthcare Spending

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Measures for 
Primary Healthcare Spending, which is currently being conducted by the 
AHRQ's Evidence-based Practice Centers (EPC) Program. Access to 
published and unpublished pertinent scientific information will improve 
the quality of this review.

DATES:  Submission Deadline on or before June 26, 2023.

ADDRESSES: 
    Email submissions: [email protected].
    Print submissions:
    Mailing Address: Center for Evidence and Practice Improvement, 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement, Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Measures for Primary 
Healthcare Spending. AHRQ is conducting this technical brief pursuant 
to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. 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 Measures for Primary Healthcare Spending, including 
those that describe adverse events. The entire research protocol is 
available online at: https://effectivehealthcare.ahrq.gov/products/primary-healthcare-spending.
    This is to notify the public that the EPC Program would find the 
following information on Measures for Primary Healthcare Spending 
helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please 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.
    [ssquf] A list of ongoing studies that 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. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; or 
information on indications not included in the review cannot be used by 
the EPC 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 EPC Program 
website 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://www.effectivehealthcare.ahrq.gov/email-updates.
    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.

Guiding Questions

    The five questions below guide our work in synthesizing a 
description of research, ongoing efforts, and directions in measuring 
primary care spending.
    1. What are the definitions, data sources, and methodologies used 
to estimate primary care spending in published reports?
    a. How do these various primary care spending estimation methods 
vary by:
    i. Relative pros and cons of each estimation method
    ii. Administrative burden
    iii. Range of spending estimates
    iv. Sensitivity analyses
    b. What is the evidence of the relationship between different 
primary care spending estimation methods and the absolute and relative 
levels of primary care spending and health outcomes including 
morbidity, mortality, quality of life, and health equity?
    2. What are the research gaps in understanding primary care 
spending estimation methods based on the findings of the evidence map?
    3. What are considerations for developing valid and standardized 
estimation of primary care spending?
    4. What are approaches that health economists, health services 
researchers, payers, health systems, and policymakers can employ to 
develop and implement a standardized measure of primary care spending 
and to assess spending over time, across payers/populations, and across 
states?
    5. Contextual Questions:
    a. Is there any emerging consensus among experts in the field 
toward a standard or preferred method for assessment of primary care 
spending?
    b. How have policymakers and other decision makers used primary 
care spending measures?

    Dated: May 22, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-11252 Filed 5-25-23; 8:45 am]
BILLING CODE 4160-90-P