2013-00031. Agency Information Collection Activities: Proposed Collection: Comment Request

ACTION:

Notice.

SUMMARY:

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [e-mail] or call the HRSA Reports Clearance Officer at [phone].

HRSA especially 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.

Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners—45 CFR Part 60 Regulations and Forms OMB No. 0915-0126—Revision

Abstract: This is a request for a revision of OMB approval of the information collections contained in regulations found at 45 CFR Part 60 governing the National Practitioner Data Bank (NPDB) and the forms to be used in registering with, reporting information to, and requesting information from the NPDB. Section 6403 of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) Public Law 111-148 requires the transfer of all data in the Healthcare Integrity and Protection Data Bank (HIPDB) to the NPDB. Data collection will not change; however, the merger will consolidate forms from OMB No. 0915-0239 for HIPDB under OMB No. 0915-0126 for NPDB. Responsibility for NPDB implementation and operation resides in the Bureau of Health Professions, Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). Operation of the HIPDB was delegated by the HHS Office of the Inspector General to HRSA. This rule eliminates duplicative data reporting and access requirements between the HIPDB [established through the Health Insurance Portability and Accountability Act of 1996 (HIPPA) under Section 1128(b)(5) of the Social Security Act (42 U.S.C. 1320a-7e)] and the NPDB [established through the Health Care Quality Improvement Act of 1986 under Title IV (42 U.S.C. 11101 et seq.) and expanded by Section 1921 of the Social Security Act (42 U.S.C. 1396r-2)]. Information previously collected and disclosed through the HIPDB will be collected and disclosed through the NPDB. Section 6403 of the Affordable Care Act consolidates the collection and disclosure of information from both data banks under Title 45 part 60 of the Code of Federal Regulations (CFR). The Department of Health and Human Services (HHS) will subsequently remove Title 45 part 61, which implemented the HIPDB.

The intent of NPDB is to improve the quality of health care by encouraging hospitals, state licensing boards, professional societies, and other entities providing health care services, to identify and discipline those who engage in unprofessional behavior; and to restrict the ability of incompetent health care practitioners, providers, or suppliers to move from state to state without disclosure of previous damaging or incompetent performance. It also serves as a fraud and abuse clearinghouse for the reporting and disclosing of certain final adverse actions (excluding settlements in which no findings of liability have been made) taken against health care practitioners, providers, or suppliers by health plans, federal agencies, and state agencies.

The NPDB acts primarily as a flagging system; its principal purpose is to facilitate comprehensive review of practitioners' professional credentials and background. Information is collected from, and disseminated to, eligible entities (entities that are entitled to query and/or report to the NPDB under the three aforementioned statutory authorities) on the following: (1) Medical malpractice payments, (2) licensure actions taken by Boards of Medical Examiners, (3) state licensure and certification actions, (4) federal licensure and certification actions, (5) negative actions or findings taken by peer review organizations or private accreditation entities, (6) adverse actions taken against clinical privileges, (7) federal or state criminal convictions related to the delivery of a health care item or service, (8) civil judgments related to the delivery of a health care item or service, (9) exclusions from participation in federal or state health care programs, and (10) other adjudicated actions or decisions. It is intended that NPDB information should be considered with other relevant information in evaluating credentials of health care practitioners, providers, and suppliers.

The reporting forms and the request for information forms (query forms) are accessed, completed, and submitted to the NPDB electronically through the NPDB Web site at http://www.npdb-hipdb.hrsa.gov/​. All reporting and querying is performed through this secure Web site.

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 verifying 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.

The annual estimate of burden is as follows:

Form name	Number of respondents	Number of responses per respondent	Total responses	Average burden per response (in hours)	Total burden hours
Entity Registration (initial)	856	1	856	1	856
Entity Registration (renewal)	12,748	1	12,748	1	12,748
Individual Subject Query	4,460,926	1	4,460,926	0.1	446,093
Individual Self Query	64,187	1	64,187	0.4	25,675
Title IV Clinical Privileges Action	862	1	862	0.75	647
Professional Society Membership Action	67	1	67	0.75	50
State Licensure Action	62,178	1	62,178	0.75	46,634
DEA/Federal Licensure Action	497	1	497	0.75	373
Exclusion/Debarment	16,243	1	16,243	0.75	12,182
Government and Administrative Action	2,592	1	2,592	0.75	1,944
Health Plan Action	515	1	515	0.75	386
Civil Judgment	10	1	10	0.75	8
Criminal Conviction	1,253	1	1,253	0.75	940
Medical Malpractice Payment	13,326	1	13,326	0.75	9,995
Private Accreditation Entity and Peer Review Organization	10	1	10	0.75	8
Authorized Agent Designation Form (Add & Edit)	2055	1	2055	0.25	514
Account Discrepancy Report	20	1	20	0.25	5
Report Review Request Form	83	1	83	.25	21
Electronic Transfer Funds Authorization	276	1	276	0.25	69
Subject Statement and Dispute Initiation Form (Individual & Organization)	100	1	100	1	100
TOTAL	4,641,704		4,641,704		561,395

ADDRESSES:

Submit your comments to [e-mail] or mail the HRSA Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.

Deadline: Comments on this Information Collection Request must be received within 60 days of this notice.

Dated: December 21, 2012.

Bahar Niakan,

Director, Division of Policy and Information Coordination.