[Federal Register Volume 86, Number 11 (Tuesday, January 19, 2021)]
[Notices]
[Pages 5220-5223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission to OMB for 
Review and Approval; Public Comment Request; 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

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

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA 
submitted an Information Collection Request (ICR) to the Office of 
Management and Budget (OMB) for review and approval. Comments submitted 
during the first public review of this ICR will be provided to OMB. OMB 
will accept further comments from the public during the review and 
approval period. OMB may act on HRSA's ICR only after the 30 day 
comment period for this notice has closed.

DATES: Comments on this ICR should be received no later than February 
18, 2021.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under Review--Open for 
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email Lisa Wright-Solomon, the 
HRSA Information Collection Clearance Officer at [email protected] or 
call (301) 443-1984.

SUPPLEMENTARY INFORMATION: 
    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

[[Page 5221]]

submit reports) and queriers (entities and individuals that are 
authorized to request for information).
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    \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.
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    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 five NPDB forms that were 
originally approved in: ``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.
    A 60-day notice published in the Federal Register on October 16, 
2020, vol. 85, No. 201; pp. 65834-65837. There were two public comments 
that addressed ways to enhance the quality, utility, and clarity of the 
information to be collected by the NPDB.
    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
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                                                                                             Number of                    Average burden   Total burden
            Regulation citation                       Form name              Number of     responses per       Total       per response   hours (rounded
                                                                            respondents     respondent       responses      (in hours)          up)
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Sec.   60.6: Reporting errors, omissions,   Correction, Revision-to-              11,918               1          11,918             .25           2,980
 revisions or whether an action is on        Action, Void, Notice of
 appeal.                                     Appeal (manual).
                                            Correction, Revision-to-              18,301               1          18,301           .0003               5
                                             Action, Void, Notice of
                                             Appeal (automated).
Sec.   60.7: Reporting medical malpractice  Medical Malpractice Payment           11,481               1          11,481             .75           8,611
 payments.                                   (manual).
                                            Medical Malpractice Payment              296               1             296           .0003               1
                                             (automated).
Sec.   60.8: Reporting licensure actions    State Licensure or                    19,749               1          19,749             .75          14,812
 taken by Boards of Medical Examiners.       Certification (manual).
Sec.   60.9: Reporting licensure and        State Licensure or                    17,189               1          17,189           .0003               5
 certification actions taken by States.      Certification (automated).
Sec.   60.10: Reporting Federal licensure   DEA/Federal Licensure.......             600               1             600             .75             450
 and certification actions.
Sec.   60.11: Reporting negative actions    Peer Review Organization....              10               1              10             .75               8
 or findings taken by peer review
 organizations or private accreditation
 entities.
                                            Accreditation...............              10               1              10             .75               8
Sec.   60.12: Reporting adverse actions     Title IV Clinical Privileges             978               1             978             .75             734
 taken against clinical privileges.          Actions.
                                            Professional Society........              41               1              41             .75              31
Sec.   60.13: Reporting Federal or State    Criminal Conviction (Guilty            1,174               1           1,174             .75             881
 criminal convictions related to the         Plea or Trial) (manual).
 delivery of a health care item or service.

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                                            Criminal Conviction (Guilty              683               1             683           .0003               1
                                             Plea or Trial) (automated).
                                            Deferred Conviction or Pre-               70               1              70             .75              53
                                             Trial Diversion.
                                            Nolo Contendere (no contest              127               1             127             .75              95
                                             plea).
                                            Injunction..................              10               1              10             .75               8
Sec.   60.14: Reporting civil judgments     Civil Judgment..............               9               1               9             .75               7
 related to the delivery of a health care
 item or service.
Sec.   60.15: Reporting exclusions from     Exclusion or Debarment                 1,707               1           1,707             .75           1,280
 participation in Federal or State health    (manual).
 care programs.
                                            Exclusion or Debarment                 2,506               1           2,506           .0003               1
                                             (automated).
Sec.   60.16: Reporting other adjudicated   Government Administrative              1,750               1           1,750             .75           1,313
 actions or decisions.                       (manual).
                                            Government Administrative                 39               1              39           .0003               1
                                             (automated).
                                            Health Plan Action..........             488               1             488             .75             366
Sec.   60.17 Information which hospitals    One-Time Query for an              1,958,176               1       1,958,176             .08         156,654
 must request from the National              Individual (manual).
 Practitioner Data Bank.
                                            One-Time Query for an              3,349,778               1       3,349,778           .0003           1,005
                                             Individual (automated).
                                            One-Time Query for an                 50,681               1          50,681             .08           4,054
                                             Organization (manual).
                                            One-Time Query for an                 25,610               1          25,610           .0003               8
                                             Organization (automated).
Sec.   60.18 Requesting Information from    Self-Query on an Individual.         168,557               1         168,557             .42          70,794
 the NPDB.
                                            Self-Query on an                       1,059               1           1,059             .42             445
                                             Organization.
                                            Continuous Query (manual)...         806,971               1         806,971             .08          64,558
                                            Continuous Query (automated)         619,001               1         619,001           .0003             186
Sec.   60.21: How to dispute the accuracy   Subject Statement and                  3,264               1           3,264             .75           2,448
 of NPDB information.                        Dispute.
                                            Request for Dispute                       74               1              74               8             592
                                             Resolution.
Administrative............................  Entity Registration                    3,484               1           3,484               1           3,484
                                             (Initial).
                                            Entity Registration (Renewal          13,245               1          13,245             .25           3,311
                                             & Update).
                                            State Licensing Board Data                60               1              60            10.5             630
                                             Request.
                                            State Licensing Board                    325               1             325               1             325
                                             Attestation.
                                            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,               274               1             274               1             274
                                             Peer Review Organization,
                                             or Private Accreditation
                                             Organization Attestation.
                                            Other Eligible Entity                  1,884               1           1,884               1           1,884
                                             Attestation.

[[Page 5223]]

 
                                            Corrective Action Plan                    10               1              10             .08               1
                                             (Entity).
                                            Reconciling Missing Actions.           1,491               1           1,491             .08             119
                                            Agent Registration (Initial)              44               1              44               1              44
                                            Agent Registration (Renewal              304               1             304             .08              24
                                             & Update).
                                            Electronic Funds Transfer                644               1             644             .08              52
                                             (EFT) Authorization.
                                            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                 10               1              10             .08               1
                                             Form.
    Total.................................  ............................       7,101,274  ..............       7,101,274  ..............         347,294
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    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.
[FR Doc. 2021-00989 Filed 1-15-21; 8:45 am]
BILLING CODE 4165-15-P