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Daily Rules, Proposed Rules, and Notices of the Federal Government

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 information collection project: "Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP)." 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 theFederal Registeron June 27th, 2012 and allowed 60 days for public comment. Several comments were received. The purposeof 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 atOIRA_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 atdoris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION: Proposed Project Online Application Order Form for Products From the Healthcare Cost and Utilization Project (HCUP)

The Healthcare Cost and Utilization Project (HCUP, pronounced “H-Cup”) is a vital resource helping AHRQ achieve its research agenda, thereby furthering its goal of improving the delivery of health care in the United States. HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership and sponsored by AHRQ. HCUP includes the largest collection of longitudinal hospital care data in the United States, with all-payer, encounter-level information beginning in 1988. The HCUP databases are annual files that contain anonymous information from hospital discharge records for inpatient care and certain components of outpatient care, such as emergency care and ambulatory surgeries. The project currently releases a variety of databases created for research use on a broad range of health issues, including cost and quality of health services, medical practice patterns, access to health care programs, and outcomes of treatments at the national, State, and local market levels. HCUP also produces a large number of software tools to enhance the use of administrative health care data for research and public health use. Software tools use information available from a variety of sources to create new data elements, often through sophisticated algorithms, for use with the HCUP databases.

HCUP's objectives are to:

• Create and enhance a powerful source of national, state, and all-payer health care data.

• Produce a broad set of software tools and products to facilitate the use of HCUP and other administrative data.

• Enrich a collaborative partnership with statewide data organizations (that voluntarily participate in the project) aimed at increasing the quality and use of health care data.

• Conduct and translate research to inform decision making and improve health care delivery.

The HCUP releases six types of databases for public research use:

(1) The Nationwide Inpatient Sample (NIS) is the largest all-payer inpatient care database in the United States, containing data from approximately 8 million hospital stays from roughly 1,000 hospitals; this approximates a 20-percent stratified sample of U.S. community hospitals. NIS data releases are available for purchase from the HCUP Central Distributor for data years beginning in 1988.

(2) The Kids' Inpatient Database (KID) is the only all-payer inpatient care database for children in the United States. The KID was specifically designed to permit researchers to study a broad range of conditions and procedures related to child health issues. The KID contains a sample of over 3 million discharges for children age 20 and younger from more than 3,500 U.S. community hospitals.

(3) The Nationwide Emergency Department Sample (NEDS) is the largest all-payer ED database in the United States. It is constructed to capture information both on ED visits that do not result in an admission and on ED visits that result in an admission to the same hospital. The NEDS contains more than 25 million unweighted records for ED visits at about 1,000 U.S. community hospitals and approximates a 20-percent stratified sample of U.S. hospital-based EDs. Files are available beginning with data year 2006.

(4) The State Inpatient Databases (SID) contain the universe of inpatient discharge abstracts from data organizations in 46 States that currently participate in the SID. Together, the SID encompasses approximately 97 percent of all U.S. community hospital discharges. Most States that participate in the SID make their data available for purchase through the HCUP Central Distributor. Files are available beginning with data year 1990.

(5) The State Ambulatory Surgery Databases (SASD) contain data from ambulatory care encounters in hospital-affiliated (and sometimes freestanding) ambulatory surgery sites. Currently, 29 States participate in the SASD. Files are available beginning with data year 1997.

(6) The State Emergency Department Databases (SEDD) contain data from hospital-affiliated emergency department (ED) abstracts for visits that do not result in a hospitalization. Currently, 29 States participate in the SEDD. Files are available beginning with data year 1999.

To support AHRQ's mission to improve health care through scientific research, HCUP databases and software tools are disseminated to users outside of the Agency through a mechanism known as the HCUP Central Distributor. The HCUP Central Distributor assists qualified researchers to access uniform research data across multiple states with the use of one application process. The HCUP databases disseminated through the Central distributor are referred to as “restricted access public release files;” that is, they are publicly available, but only under restricted conditions.

HCUP databases are released to researchers outside of AHRQ after the completion of required training and submission of an application that includes a signed FICUP Data Use Agreement (DUA). In addition, before restricted access public release state-level databases are released, the user is asked for a brief description of their research to ensure that the planned use is consistent with HCUP policies and with the FICUP data use requirements. Fees are set for databases released through the HCUP Central Distributor depending on the type of database. The fee for sale of state-level data is determined by each participating Statewide Data Organization and reimbursed to those organizations. This project is being conducted by AHRQ through its contractor and subcontractor, Thomson Reuters and Social & Scientific Systems, Inc., pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the outcomes, cost, cost-effectiveness, and use of health care services and access to such services. (42 U.S.C. 299a(a)(3).)

Method of Collection

This information collection request is for the activities associated with completing an online application form to request HCUP data, not the collection of health care data for HCUP databases. The activities associated with the HCUP online application include:

(1) HCUP Application Form. All persons wanting access to the HCUP databases must complete an application package. Each unique database has a unique application package. All application packages are available fordownloading athttp://www.hcup-us.ahrq.gov/tech_assist/centdist.jsp.

(2) HCUP Data Use Agreement Training. All persons wanting access to the HCUP databases must complete this online training course. The purpose of the training is to emphasize the importance of data protection, reduce the risk of inadvertent violations, and describe the individual's responsibility when using HCUP data. The training course can be accessed and completed online athttp://www.hcup-us.ahrq.gov/tech_assist/dua.jsp.

(3) HCUP Data Use Agreement (DUA). All persons wanting access to the HCUP databases must sign a data use agreement. Each database has a unique DUA; an example DUA for the Nationwide Inpatient Sample database is available athttp://www.hcup-us.ahrq.gov/team/NISDUA.jsp.

Information collected in the HCUP Application Order Form will be used for two purposes only:

1.Business Transaction:HCUP databases and software are currently delivered on disk and shipped to users who have completed the application process. Contact information is used for shipping the data on disk (or any other media used in the future). AHRQ policy and current agreements with Statewide Data Organizations contributing data to HCUP prohibit providing access to the data via the Internet or email.

2.Enforcement of the HCUP Data Use Agreement (DUA):The HCUP DUA contains several restrictions on use of the data. Most of these restrictions have been put in place to safeguard the privacy of individuals and establishments represented in the data. For example, data users can only use the data for research, analysis, and aggregate statistical reporting and are prohibited from attempting to identify any persons in the data. Contact information on HCUP Data Use Agreements is retained in the event that a violation of the DUA takes place.

Estimated Annual Respondent Burden

Exhibit 1 shows the estimated annualized burden associated with the applicants' time to order any of the HCUP databases. An estimated 1,200 persons will order HCUP data annually. Each of these persons will complete an application (10 minutes), the DUA training (15 minutes) and a DUA (5 minutes). The total burden is estimated to be 600 hours annually.

Exhibit 2 shows the estimated annualized cost burden associated with the applicants' time to order HCUP data. The total cost burden is estimated to be $21,408 annually.

Exhibit 1—Estimated Annualized Burden Hours Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Hours per
  • response
  • Total burden hours
    HCUP Application Form 1,200 1 10/60 200 HCUP DUA Training 1,200 1 15/60 300 HCUP DUA 1,200 1 5/60 100 Total 3,600 na na 600
    Exhibit 2—Estimated Annualized Cost Burden Form name Number of
  • respondents
  • Total burden hours Average hourly wage rate * Total cost
  • burden
  • HCUP Application Form 1,200 200 $35.68 $7,136 HCUP DUA Training 1,200 300 35.68 10,704 HCUP DUA 1,200 100 35.68 3,568 Total 3,600 600 na 21,408 * Based upon the mean of the average wages for Life Scientists, All Other (19-1099), National Compensation Survey: Occupational wages in the United States May 2011, “U.S. Department of Labor, Bureau of Labor Statistics.”
    Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the estimated total and annualized cost to process HCUP database applications and maintain the ordering system over the 3 years covered by this information collection request. It is estimated to cost $17,237 annually to operate and maintain the ordering system.

    Exhibit 3—Estimated Total and Annualized Cost Cost component Total cost Annualized cost Order Review $14,493 $4,831 Monthly Updates—Product Catalog 1,857 619 System Maintenance 13,820 4,607 Customer Inquiries 4,483 1,495 Management/Troubleshooting 17,058 5,689 Total 51,711 17,237 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 13, 2012. Carolyn M. Clancy, Director.