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Notice

Agency Information Collection Activities: Proposed Collection; Comment Request

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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: “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 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 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 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.

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 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

Data collectionNumber of nominationsNumber of responses per nominationHours per responseTotal burden hours
CHIPRA PQMP Candidate Measure Submission Form7513.25244

Exhibit 2—Estimated annualized cost burden

Data collectionNumber of nominationsTotal burden hoursAverage hourly wage rate*Total cost burden
CHIPRA PQMP Candidate Measure Submission Form75244$78.67$19,195
* 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

Cost componentTotal costAnnualized cost
Project Development$16,205$5,402
Data Collection Activities46,55315,518
Data Processing and Analysis43,19014,397
Publication of Results53,93817,979
Project Management22,6207,540
Overhead92,76430,921
Total275,27091,757

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