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[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Notices]
[Pages 23260-23263]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9105]

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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: ``CHIPRA Pediatric Quality Measures Program Candidate Measure 
Submission Form.'' In accordance with the Paperwork Reduction Act, 44 
U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed 
information collection.

DATES: Comments on this notice must be received by June 18, 2012.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
doris.lefkowitz@AHRQ.hhs.gov.
    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 email at 
doris.lefkowitz@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Proposed Project

Pediatric Quality Measures Program

    Section 401(a) of the Children's Health Insurance Program 
Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the 
Social Security Act (``the Act'') to enact section 1139A (42 U.S.C. 
1320b-9a). Section 1139A(b) charged the Department of Health and Human 
Services (HHS) with improving pediatric health care quality measures. 
Since CHIPRA was passed, AHRQ and the Centers for Medicare & Medicaid 
Services (CMS) have been working together to implement selected 
provisions of the legislation related to children's health care 
quality. An initial core measure set for voluntary use by Medicaid and 
Children's Health Insurance Programs (CHIP) was posted December 29, 
2009 (http://www.gpo.gov/fdsys/pkg/FR-2009-12-29/html/E9-30802.htm). In 
February 2010, CMS released a State Health Official letter which 
outlined the initial core measures and how these measures would be 
reported to CMS.
    Subsequently, AHRQ and CMS established the CHIPRA Pediatric Quality 
Measures Program (PQMP) in accordance with section 1139A(b)(1) of the 
Act to enhance select children's health care quality measures and 
develop new measures (http://www.ahrq.gov/chipra). The PQMP is intended 
to increase the portfolio of measures available to public and private 
purchasers of children's health care services, providers, and 
consumers. HHS anticipates that measures ultimately included in the 
Improved Core Set will also be used by public and private purchasers to 
measure pediatric healthcare quality. The PQMP consists of the 
following:
    (1) Seven Centers of Excellence (CoEs) that are developing and/or 
enhancing children's health care quality measures through cooperative 
agreements with AHRQ in order to increase the portfolio of measures 
available to the public and private purchasers of children's health 
care services, providers and consumers (http://www.ahrq.gov/chipra/pqmpfact.htm);
    (2) CHIPRA Coordinating and Technical Assistance Center (CCTAC);
    (3) Two CHIPRA quality demonstration grantees (Illinois, a partner 
to the Florida grantee, and Massachusetts) funded by CMS to undertake 
new quality measure development as part of their grants http://www.insurekidsnow.gov/professionals/CHIPRA/grants_summary.html; and
    (4) The Subcommittee on Children's Healthcare Quality Measures of 
the AHRQ National Advisory Council on Healthcare Research and Quality 
(SNAC) that will review measures nominated through a public call for 
measures, as well as measures developed or enhanced by the CoEs, and 
make recommendations for an improved core set of children's health care 
quality measures and other CHIPRA purposes (http://www.ahrq.gov/chipra/panellist11.htm).
    Section 1139A of the Act provides that improved core sets of 
children's health care quality measures be identified beginning January 
1, 2013, and annually thereafter, for potential voluntary use by 
Medicaid and CHIP programs and other CHIPRA purposes. AHRQ intends to 
solicit nominations for children's health care quality measures for 
these purposes using a standard measure nomination form early in 
calendar years 2013 and 2014 through a public call for measures. These 
solicitations will be undertaken by AHRQ to identify children's health 
care quality measures for review by the SNAC.
    Section 1139A(b)(2) of the Act requires that the measures in the 
improved core sets shall, at a minimum, be:
    (A) Evidence-based and, where appropriate, risk adjusted;
    (B) Designed to identify and eliminate racial and ethnic 
disparities in child health and the provision of health care;
    (C) Designed to ensure that the data required for such measures is 
collected and reported in a standard format that permits comparison of 
quality and data at a State, plan, and provider level;
    (D) Periodically updated; and
    (E) Responsive to the child health needs, services, and domains of 
health care quality described in clauses (i), (ii), and (iii) of 
subsection (a)(6)(A).
    Hence, AHRQ, CMS, and PQMP developed a CHIPRA Pediatric Quality 
Measures Program (PQMP) Candidate Measure Submission Form (hereinafter 
referred to as ``CHIPRA PQMP Candidate Measure Submission Form'') and a 
Glossary of Terms. The CHIPRA PQMP Candidate Measure Submission Form 
and Glossary of Terms detail the measure evaluation criteria and 
related definitions to provide operational guidance for the minimum 
evaluation criteria as specified in section 1139A(b)(2) of the Act. 
AHRQ intends to use this CHIPRA PQMP Candidate Measure Submission Form 
to conduct a public call for measures early in calendar years 2013 and 
2014 to solicit measures for consideration by the SNAC for the 2014 and 
2015 improved core sets of children's health care quality measures for 
voluntary use by Medicaid and CHIP programs and for other CHIPRA 
purposes.
    The goals of the CHIPRA PQMP Candidate Measure Form project are to:
    (1) Solicit nominations for children's health care quality measures 
early in calendar years 2013 and 2014 through public calls for 
measures, using a standardized data collection form;
    (2) Use the information provided through the standardized data 
collection form to support SNAC review of children's health care 
quality measures nominated by the public and measures developed by the 
seven CoEs; and
    (3) Identify measures for improved core sets of children's health 
care quality measures and for other CHIPRA purposes.

[[Page 23261]]

    The process for review of the measures developed by the seven COEs 
will be the same as that for measures submitted in response to calls 
for public nominations.
    Respondents to these public calls for measures in 2013 and 2014 are 
expected to include pediatricians, researchers, measure developers, and 
measure stewards of children's health care quality measures.
    This project is being conducted by AHRQ pursuant to AHRQ's 
statutory authority under Title IX of the Public Health Service Act to 
conduct and support research to improve health care quality, and to 
fulfill a number of requirements under Title IV of CHIPRA, including 
requirements to identify candidate measures for public posting of an 
improved core set of children's health care quality measures by January 
1, 2014 and January 1, 2015.

Method of Collection

    To achieve the goals of this project, AHRQ intends to solicit 
submission of measures from the members of the public using the CHIPRA 
PQMP Candidate Measure Submission Form, a standardized data collection 
tool. Data collection using the CHIPRA PQMP Candidate Measure 
Submission Form will be adequate to achieve the goals of the project. 
Below is an outline of the type of data collected through the CHIPRA 
PQMP Candidate Measure Submission Form and description of the 
information solicited from each nominator pursuant to section 
1139A(b)(2) of the Act.
    1. Basic measure information, including: measure name, measure 
description, denominator statement (if applicable), numerator statement 
(if applicable), data sources, exclusions, measure owner and/or 
copyright owner and any other applicable proprietary rights (e.g., 
patent or data rights), any confidentiality or trade secret 
protections, National Quality Forum (NQF) identification number (if 
applicable; i.e., if the measure has been endorsed by NQF), and whether 
part of a measure hierarchy (e.g., a collection of measures, a measure 
set, a measure subset as defined at http://www.qualitymeasures.ahrq.gov/about/hierarchy.aspx).
    2. Detailed measure specifications: Description of how a measure 
would be calculated from appropriate data sources.
    3. Importance of the measure: Description of how the measure meets 
one or more of the following criteria for importance, citing scientific 
literature and providing references: importance to Medicaid and/or CHIP 
program, including the extent to which Medicaid/CHIP policies can 
stimulate improvement on the measure, and relevance to Early Periodic 
Screening, Diagnosis, and Treatment benefit; potential for quality 
improvement and reduction of disparities in quality; health importance/
prevalence of condition; health importance/severity and burden 
(including impact on children, families and societies); overall cost 
burden to patients, families, public and private payers, or society 
more generally currently and over the life span of the child; 
association of measure topic to children's current or future health; 
how the underlying concept of the measure changes in meaning and 
manifestation (if at all) across developmental stages.
    4. Settings, services, measure domains, and populations addressed 
by the measure. CHIPRA asks that the improved core sets cover the 
following domains of healthcare quality for children at a minimum: the 
duration of children's coverage over a 12 month time period; the 
availability and effectiveness of a full range of: (i) Preventive 
services, treatments, and services for acute conditions, including 
services to promote healthy birth, prevent and treat premature birth, 
and detect the presence or risk of physical or mental conditions that 
could adversely affect growth and development; (ii) treatments to 
correct or ameliorate the effects of physical and mental conditions, 
including chronic conditions, in infants, young children, school-age 
children, and adolescents; (iii) the availability of care in a range of 
ambulatory and inpatient health care settings in which such care is 
furnished; and, (iv) the types of measures that, taken together, can be 
used to estimate the overall national quality of health care for 
children, including children with special needs, and to perform 
comparative analyses of pediatric health care quality and racial, 
ethnic, and socioeconomic disparities in child health and healthcare 
for children. Nominations will need to identify all settings, services, 
measure domains, and populations that a measure addresses.
    5. Evidence for focus of the measure: The evidence base for the 
focus of the measures included in the January 1, 2014 and January 1, 
2015 improved core sets will be made explicit and transparent; thus, it 
is critical for nominations to specify the scientific evidence or other 
basis for the focus of the measure, including a brief description of 
the evidence base or rationale for the relationship between the measure 
and a significant structure, process, or outcome that influences 
children's health and health care.
    6. Scientific soundness of the measure: Explanation of methods to 
determine the scientific soundness of the measure itself, including 
results of all tests of validity and reliability, including 
description(s) of the study sample(s) and methods used to arrive at the 
results. Also, information on how characteristics of the data system/
data sources may affect validity and reliability of the measure.
    7. Identification of disparities: CHIPRA requires that quality 
measures be able to identify disparities by race, and ethnicity, and be 
responsive to domains of health care quality such as socioeconomic 
status, and special health care needs. Nominations will provide 
evidence (if available) from testing of measures with diverse 
populations (considering that diversity may include race, ethnicity, 
rural populations, inner city populations, special health care needs, 
socioeconomic status, and/or insurance source, especially Medicaid or 
CHIP) to assess measure's performance for disparities identification.
    8. Feasibility: Description of the measure's feasibility, 
including: availability of data in existing data systems; 
opportunities/pathways for implementation; extent to which the measure 
has been used or is in use (or has not been used), including settings 
in which it has been used; data collection methods that have been used; 
eligible populations and results of testing in the eligible 
populations, including an estimation of the population size required to 
gain adequate numbers of observations for reliable comparisons, such as 
estimates of the required population sizes to gain adequate numbers for 
stratification by race, ethnicity, special health care need, and 
socioeconomic status.
    9. Levels of aggregation: CHIPRA states that data used in quality 
measures must be collected and reported in a standard format that 
permits comparison (at minimum) at State, health plan, and provider 
levels. Nominations will provide information on all levels of 
aggregation at which the measure is primarily intended to apply (e.g., 
State (Medicaid and CHIP populations), health plan, hospital, practice, 
provider, patient) and at which the measure has been tested.
    10. Understandability: CHIPRA states that the core set should allow 
purchasers, families, and health care providers to understand the 
quality of care for children. Nominations will include a description of 
the usefulness of the measure to purchasers, families,

[[Page 23262]]

and health care providers and present results from efforts to assess 
the understandability of the measure.
    11. Health Information Technology: Nominations will provide 
information on health information technology (HIT) that has been or 
could be incorporated into the measure calculation.
    12. Additional Disclosures and Notices: All nominations will 
include contact information for the measure submitter, including: (a) 
Name, (b) Title, (c) Organization, (d) Mailing address, (e) Telephone 
number, and (f) email address. Further, all nominations will include a 
written statement disclosing the proprietary and/or confidentiality 
status of the measure and full measure specifications, as described in 
the Basic Measure Information category. This statement must be signed 
by the applicable rights holder(s) or an individual authorized to act 
on its behalf for each submitted measure or instrument. If signed by an 
authorized individual, the statement must describe the basis for such 
authorization. Submitters are encouraged to disclose the terms under 
which the measure and full measure specifications are currently made 
available to interested parties--for example, a standard license and/or 
nondisclosure agreement, or a statement describing the terms thereof. 
Should HHS accept the measure for the 2014 and/or 2015 Improved Core 
Measure Sets, full measure specifications for the accepted measure will 
be subject to public disclosure (e.g., on the AHRQ and/or CMS Web 
sites). In addition, AHRQ expects that measures and full measure 
specifications will be made reasonably available to all interested 
parties.
    The information resulting from this data collection will be used 
to: (a) Improve and strengthen the initial core set of measures of 
health care quality measures established under CHIPRA in December 2009 
(http://www.gpo.gov/fdsys/pkg/FR-2009-12-29/html/E9-30802.htm), (b) 
expand on existing pediatric quality measures used by public and 
private health care purchasers, and (c) increase the portfolio of 
evidence-based consensus pediatric quality measures available to public 
and private purchasers of children's health care services, providers, 
and consumers.
    Each measure nominated by members of the public will be reviewed by 
members of SNAC using the categories of evaluation criteria detailed in 
the CHIPRA PQMP Candidate Measure Submission Form. SNAC will make 
recommendations to NAC which in turn make recommendations to the AHRQ 
Director for consideration of select measures for inclusion in the 
public posting of an improved core set by January 1, 2014 and January 
1, 2015 for voluntary use by Medicaid and CHIP programs and other 
CHIPRA purposes.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for members 
of the public who will nominate measures through use of the online 
CHIPRA PQMP Candidate Measure Submission Form. We anticipate a maximum 
of 50 nominations each year with each nomination requiring three hours. 
The total burden is estimated to be 150 hours annually.
    Exhibit 2 shows the estimated annualized cost burden for 
respondents' to complete the online submission form for the public call 
for measures. The total cost burden is estimated to be $11,801 
annually.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                  Number of
               Data collection                   Number of      responses per      Hours per       Total burden
                                                nominations      nominations        response          hours
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CHIPRA PQMP Candidate Measure Submission                  50                1                3              150
 Form.......................................
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                 Number of       Total burden    Average hourly     Total cost
               Data collection                  nominations         hours          wage rate*         burden
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CHIPRA PQMP Candidate Measure Submission                  50              150           $78.67          $11,801
 Form.......................................
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*Based upon the mean of the average wages for 29-1065 (Pediatricians, General), $78.67 per hour, National
  Compensation Survey: Occupational wages in the United States May 2009, U.S. Department of Labor, Bureau of
  Labor Statistics. Although the measure nominations will be solicited from the general public, AHRQ is using
  the wage rate for pediatricians since our expectation is that respondents to the 2013 and 2014 public call for
  measures will primarily be pediatricians who will be measure developers or measure stewards of children's
  health care quality measures.

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the estimated total and annualized cost over 3 
years to the government for conducting this project. The total cost is 
estimated to be $275,270.

             Exhibit 3--Estimated Total and Annualized Cost
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                                                              Annualized
                Cost component                   Total cost      cost
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Project Development...........................      $16,205       $5,402
Data Collection Activities....................       46,553       15,518
Data Processing and Analysis..................       43,190       14,397
Publication of Results........................       53,938       17,979
Project Management............................       22,620        7,540
Overhead......................................       92,764       30,921

[[Page 23263]]

 
    Total.....................................      275,270       91,757
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Request for Comments

    In accordance with the Paperwork Reduction Act, 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 healthcare research and 
healthcare 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 request for OMB approval of the 
proposed information collection. All comments will become a matter of 
public record.

    Dated: April 6, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-9105 Filed 4-17-12; 8:45 am]
BILLING CODE 4160-90-M
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