2020-22953. Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners-45 CFR ...

AGENCY:

Health Resources and Services Administration (HRSA), Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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 ICR should be received no later than December 15, 2020.

ADDRESSES:

Submit your comments to [e-mail] or mail the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, Maryland 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 [e-mail] or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at [phone].

SUPPLEMENTARY INFORMATION:

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

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 OMB's approval for a revision to the information collection 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. Administrative forms are also included to aid in monitoring compliance with Federal reporting and querying requirements. Responsibility for NPDB implementation and operation resides in HRSA's Bureau of Health Workforce. The intent of the NPDB is to improve the quality of health care by encouraging entities such as hospitals, State licensing boards, professional societies, and other eligible entities ^[1] 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 or discovery 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. Users of the NPDB include reporters (entities that are required to submit reports) and queriers (entities and individuals that are authorized to request for information).

The reporting forms, request for information forms (query forms), and administrative forms (used to monitor compliance) are accessed, completed, and submitted to the NPDB electronically through the NPDB website at https://www.npdb.hrsa.gov/​. All reporting and querying is performed through the secure portal of this website.

This revision proposes changes to improve overall data integrity. In addition, this revision contains the four NPDB forms that were originally approved in the “National Practitioner Data Bank (NPDB) Attestation of Reports by Hospitals, Medical Malpractice Payers, Health Plans, and Certain Other Health Care Entities, OMB No. 0906-0028” which will be discontinued upon approval of this ICR.

Need and Proposed Use of the Information: 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 as authorized in Title 45 CFR part 60 of the Code of Federal Regulations) 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.

Likely Respondents: Eligible entities or individuals that are entitled to query and/or report to the NPDB as authorized in regulations found at 45 CFR part 60.

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 ICR are summarized in the table below.

Total Estimated Annualized Burden Hours

Regulation citation	Form name	Number of respondents	Number of responses per respondent	Total responses	Average burden per response (in hours)	Total burden hours (rounded up)
§ 60.6: Reporting errors, omissions, revisions or whether an action is on appeal.	Correction, Revision-to-Action, Void, Notice of Appeal (manual)	11,918	1	11,918	.25	2,980
	Correction, Revision-to-Action, Void, Notice of Appeal (automated)	18,301	1	18,301	.0003	5
§ 60.7: Reporting medical malpractice payments	Medical Malpractice Payment (manual)	11,481	1	11,481	.75	8,611
	Medical Malpractice Payment (automated)	296	1	296	.0003	1
§ 60.8: Reporting licensure actions taken by Boards of Medical Examiners	State Licensure or Certification (manual)	19,749	1	19,749	.75	14,812
§ 60.9: Reporting licensure and certification actions taken by States	State Licensure or Certification (automated)	17,189	1	17,189	.0003	5
§ 60.10: Reporting Federal licensure and certification actions.	DEA/Federal Licensure	600	1	600	.75	450
§ 60.11: Reporting negative actions or findings taken by peer review organizations or private accreditation entities	Peer Review Organization	10	1	10	.75	8
	Accreditation	10	1	10	.75	8
§ 60.12: Reporting adverse actions taken against clinical privileges	Title IV Clinical Privileges Actions	978	1	978	.75	734
	Professional Society	41	1	41	.75	31
§ 60.13: Reporting Federal or State criminal convictions related to the delivery of a health care item or service	Criminal Conviction (Guilty Plea or Trial) (manual)	1,174	1	1,174	.75	881
	Criminal Conviction (Guilty Plea or Trial) (automated)	683	1	683	.0003	1
	Deferred Conviction or Pre-Trial Diversion	70	1	70	.75	53
	Nolo Contendere (no contest plea)	127	1	127	.75	95
	Injunction	10	1	10	.75	8
§ 60.14: Reporting civil judgments related to the delivery of a health care item or service	Civil Judgment	9	1	9	.75	7
§ 60.15: Reporting exclusions from participation in Federal or State health care programs	Exclusion or Debarment (manual)	1,707	1	1,707	.75	1,280
	Exclusion or Debarment (automated)	2,506	1	2,506	.0003	1
§ 60.16: Reporting other adjudicated actions or decisions	Government Administrative (manual)	1,750	1	1,750	.75	1,313
	Government Administrative (automated)	39	1	39	.0003	1
	Health Plan Action	488	1	488	.75	366
§ 60.17 Information which hospitals must request from the National Practitioner Data Bank	One-Time Query for an Individual (manual)	1,958,176	1	1,958,176	.08	156,654
§ 60.18 Requesting Information from the NPDB	One-Time Query for an Individual (automated)	3,349,778	1	3,349,778	.0003	1,005
	One-Time Query for an Organization (manual)	50,681	1	50,681	.08	4,054
	One-Time Query for an Organization (automated)	25,610	1	25,610	.0003	8
	Self-Query on an Individual	168,557	1	168,557	.42	70,794
	Self-Query on an Organization	1,059	1	1,059	.42	445
	Continuous Query (manual)	806,971	1	806,971	.08	64,558
	Continuous Query (automated)	619,001	1	619,001	.0003	186
§ 60.21: How to dispute the accuracy of NPDB information	Subject Statement and Dispute	3,264	1	3,264	.75	2,448
	Request for Dispute Resolution	74	1	74	8	592
Administrative	Entity Registration (Initial)	3,484	1	3,484	1	3,484
	Entity Registration (Renewal & Update)	13,245	1	13,245	.25	3,311
	State Licensing Board Data Request	60	1	60	10.5	630
	State Licensing Board Attestation	325	1	325	1	325
	Authorized Agent Attestation	350	1	350	1	350
	Health Center Attestation	722	1	722	1	722
	Hospital Attestation	3,416	1	3,416	1	3,416
	Medical Malpractice Payer, Peer Review Organization, or Private Accreditation Organization Attestation	274	1	274	1	274
	Other Eligible Entity Attestation	1,884	1	1,884	1	1,884
	Corrective Action Plan (Entity)	10	1	10	.08	1
	Reconciling Missing Actions	1,491	1	1,491	.08	119
	Agent Registration (Initial)	44	1	44	1	44
	Agent Registration (Renewal & Update)	304	1	304	.08	24
	Electronic Funds Transfer (EFT) Authorization	644	1	644	.08	52
	Authorized Agent Designation	183	1	183	.25	46
	Account Discrepancy	85	1	85	.25	21
	New Administrator Request	600	1	600	.08	48
	Purchase Query Credits	1,786	1	1786	.08	143
	Education Request	40	1	40	.08	3
	Account Balance Transfer	10	1	10	.08	1
	Missing Report From Query Form	10	1	10	.08	1
Total		7,101,274		7,101,274		347,294

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.

Maria G. Button,

Director, Executive Secretariat.

Footnotes

1.  “Other eligible entities” that participate in the NPDB are defined in the provisions of Title IV, Section 1921, Section 1128E, and implementing regulations. In addition, a few federal agencies also participate with the NPDB through federal memorandums of understanding. Eligible entities are responsible for complying with all reporting and/or querying requirements that apply; some entities may qualify as more than one type of eligible entity. Each eligible entity must certify its eligibility in order to report to the NPDB, query the NPDB, or both. Information from the NPDB is available only to those entities specified as eligible in the statutes and regulations. Not all entities have the same reporting requirements or level of query access.