Agency Information Collection Activities: Proposed Collection: Public Comment Request

AGENCY:

Health Resources and Services Administration, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

DATES:

Comments on this Information Collection Request must be received no later than August 9, 2016.

ADDRESSES:

Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14A39, 5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443-1984.

SUPPLEMENTARY INFORMATION:

When submitting comments or requesting information, please include the information collection request title for reference.

Information Collection Request Title: National Practitioner Data Bank (NPDB) Attestation of Reports by Hospitals, Medical Malpractice Payers, Health Plans, and Health Centers.

OMB No. 0915-xxxx—New.

Abstract: The NPDB plans to collect data from hospitals, medical malpractice payers, health plans, and certain other health care entities that are subject to NPDB reporting requirements to assist these entities in understanding and meeting their reporting requirements to the NPDB. The NPDB currently collects similar data from state licensing boards on a regular basis, and this information collection request would expand beyond current reporting activities to include hospitals, medical malpractice payers, health plans, and certain health care entities.

The NPDB began operation on September 1, 1990. The statutory authorities establishing and governing the NPDB are title IV of Public Law (Pub. L.) 99-660, the Health Care Quality Improvement Act of 1986, as amended, section 5 of the Medicare and Medicaid Patient and Program Protection Act of 1987, Public Law 100-93, codified as section 1921 of the Social Security Act, and section 221(a) of the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, codified as section 1128E of the Social Security Act. Final regulations governing the NPDB are codified at 45 CFR part 60. Responsibility for NPDB implementation and operation resides in the Bureau of Health Workforce, Health Resources and Services Administration, Department of Health and Human Services (HHS).

The NPDB acts primarily as a flagging system; its principal purpose is to facilitate comprehensive review of practitioners' professional credentials and background. Information on medical malpractice payments, health-related civil judgments, adverse licensure actions, adverse clinical privileging actions, adverse professional society actions, and Medicare/Medicaid exclusions is collected from and disseminated to eligible entities such as licensing boards, hospitals, and other health care entities. It is intended that NPDB information should be considered with other relevant information in evaluating a practitioner's credentials.

The NPDB outlines specific reporting requirements for hospitals, medical malpractice payers, health plans, and health care entities; per 45 CFR 60.7, 60.12, 60.14, 60.15, and 60.16. These reporting requirements are further explained in chapter E of the NPDB e-Guidebook, which can be found at: http://www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp .

Through a process called Attestation, hospitals, medical malpractice payers, health plans, and certain other health entities will be required to attest that they understand and have met their responsibility to submit all required reports to the NPDB. The Attestation process will be completely automated through the secure NPDB system ( https://www.npdb.hrsa.gov ), using both secure email messaging and system notifications to alert entities registered with the NPDB of their responsibility to attest. All entities with reporting requirements and querying access to the NPDB must register with the NPDB before gaining access to the secure NPDB system for all reporting and querying transactions.

Although the Attestation process and forms are new, the secure NPDB system currently used by hospitals, medical malpractice payers, health plans, and health care entities to conduct reporting and querying will not change, ensuring that these entities are familiar with the interface needed to complete the Attestation process. NPDB will ask these entities to attest their reporting compliance every 2 years. If the organization is responsible for privileging or credentialing individuals who provide services for other sites, those sites will be included in the Attestation process.

The Attestation forms will collect the following information: (1) Information regarding sub-sites and entity relationships; (2) contact information for the Attesting Official; and (3) a statement attesting whether or not all required reports have been submitted.

Need and Proposed Use of the Information: The NPDB engages in compliance activities to ensure the accuracy and completeness of the information in the NPDB. Through the Attestation process, the NPDB can better determine which hospitals, medical malpractice payers, health plans, and health care entities are meeting the reporting requirements, and which of these entities may require additional outreach and assistance. The Attestation process will strengthen the robustness of the data in the NPDB, improving the accuracy of query responses for entities with access to NPDB reports.

Likely Respondents: Hospitals medical malpractice payers, health plans, health care entities, and their representatives.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and attesting information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below.

Total Estimated Annualized burden hours:

HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.