[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58389-58393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23162]


-----------------------------------------------------------------------

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

[[Page 58390]]

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.
    This proposed information collection was previously published in 
the Federal Register on April 18th, 2012 and allowed 60 days for public 
comment. Two public 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 22, 2012.

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 [email protected] (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 email at 
[email protected].

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 2011, CMS released a State Health Official letter which 
outlined the initial core measure set and how these measures should be 
reported to CMS. The Technical Specifications and Resource Manual for 
the initial core measure set for federal fiscal year 2011 reporting is 
available at http://www.medicaid.gov/Medicaid-CHIP-ProgramInformation/By-Topics/Quality-of-Care/Downloads/InitialCoreSetResouceManual.pdf.
    As required by CHIPRA, by January 1, 2011, 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 develop evidence-based, consensus measures to 
improve the initial core set and increase the portfolio of measures 
available to other 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://ahrq.gov/CHIPRA/qmsnaclist12.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 voluntary use by state Medicaid 
and CHIP programs and other CHIPRA purposes. AHRQ intends to solicit 
public nominations for children's health care quality measures using a 
standard measure nomination form in early 2013 and 2014. 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 (Attachment 
A, hereinafter referred to as ``CHIPRA PQMP Candidate Measure 
Submission Form''). The CHIPRA PQMP Candidate Measure Submission Form 
details the desirable attributes of measures and related definitions to 
provide operational guidance 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 
respective 2014 and 2015 improved core sets of children's health care 
quality measures.
    The goals of the CHIPRA PQMP Candidate Measure Form are to:
    (1) Solicit nominations for children's health care quality measures 
in early 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.
    The process for review of the measures developed by the seven COEs 
will be the same as that for publicly nominated measures.
    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.

[[Page 58391]]

    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, measure owner, National Quality Forum (NQF) identification 
number (if applicable; i.e., if the measure has been endorsed by NQF), 
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), numerator statement 
and numerator exclusions (as appropriate), denominator statement and 
denominator exclusions (as appropriate), and data sources.
    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: evidence for general importance of 
the measure including 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; importance to Medicaid and/or CHIP program, including the 
extent to which the measure is understood to be sensitive to changes in 
Medicaid or CHIP (e.g., policy changes, quality improvement 
strategies), relevance to Early Periodic Screening, Diagnosis, and 
Treatment benefit in Medicaid and any other specific relevance to 
Medicaid/CHIP; and description of how the measure complements or 
improves on an existing measure in this topic area for the child or 
adult population or if it is intended to fill a specific gap in an 
existing measure category or topic.
    4. Measure Categories addressed by the measure: CHIPRA asks that 
the improved core set, taken together, cover all settings, services, 
and topics of health care relevant to children. Moreover, the 
legislation requires the core set to address the needs of children 
across all ages including services to promote healthy birth. Regardless 
of the eventual use of the measure, nominators will need to provide 
information on all settings, services, measure topics, and populations 
that a measure addresses.
    5. Evidence or other justification for the 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, special health 
care needs, socioeconomic status, rural populations, inner city 
populations, and Limited English Proficiency populations 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, 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. Limitations of the measure: Nominations will provide brief 
description of any limitations of the measure related to the attributes 
included in the form.
    13. Summary Statement: Nominations will provide a summary rationale 
for why the measure should be selected for use, taking into account a 
balance among desirable attributes and limitations of the measure.
    14. Identifying information for the measure submitter: 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

[[Page 58392]]

confidentiality status of the measure and full measure specifications, 
as described in the Public Disclosure Requirements. 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.
    15. Opportunity to upload supplementary material: Nominations will 
have opportunity to upload attachments including graphics, tables, 
diagrams, and any other supplemental material. This information 
supports the review of the measure.
    16. Glossary of Terms: The glossary of terms details the 
definitions for key desirable attributes of measures in the PQMP 
Candidate Measure Submission Form.
    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 established under CHIPRA (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.
    All measures nominated by members of the public will be reviewed by 
members of the SNAC using the categories of desirable attributes 
detailed in the CHIPRA PQMP Candidate Measure Submission Form. The SNAC 
will make recommendations to NAC which in turn will 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 75 nominations each year with each nomination requiring 3.25 hours. 
The total burden is estimated to be 244 hours annually.
    Exhibit 2 shows the estimated annualized cost burden for 
respondents' time to complete the online submission form for the public 
call for measures. The total cost burden is estimated to be $19,195 
annually.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                  Number of
               Data collection                   Number of      responses per      Hours per      Total  burden
                                                nominations       nomination        response          hours
----------------------------------------------------------------------------------------------------------------
CHIPRA PQMP Candidate Measure Submission                  75                1             3.25              244
 Form.......................................
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated annualized cost burden
----------------------------------------------------------------------------------------------------------------
                                                 Number of      Total  burden   Average  hourly    Total  cost
               Data collection                  nominations         hours          wage rate*         burden
----------------------------------------------------------------------------------------------------------------
CHIPRA PQMP Candidate Measure Submission                  75              244           $78.67          $19,195
 Form.......................................
----------------------------------------------------------------------------------------------------------------
* 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
------------------------------------------------------------------------
                                                            Annualized
             Cost component                 Total cost         cost
------------------------------------------------------------------------
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
                                         -------------------------------
    Total...............................         275,270          91,757
------------------------------------------------------------------------


[[Page 58393]]

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: September 6, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-23162 Filed 9-19-12; 8:45 am]
BILLING CODE 4160-90-M