[Federal Register Volume 84, Number 244 (Thursday, December 19, 2019)]
[Notices]
[Pages 69751-69753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27395]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request; Information Collection Request Title: National 
Practitioner Data Bank Attestation of Reports by Hospitals, Medical 
Malpractice Payers, Health Plans, Health Centers, and Other Eligible 
Entities

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

ACTION: Notice.

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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 February 
18, 2020.

ADDRESSES: Submit your comments to [email protected] 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 [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301) 
443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the ICR title for reference.
    Information Collection Request Title: National Practitioner Data 
Bank (NPDB) Attestation of Reports by Hospitals, Medical Malpractice 
Payers, Health Plans, Health Centers, and Other Eligible Entities, OMB 
No. 0906-0028--Revision.
    Abstract: NPDB proposes to continue collecting data from entities, 
such as hospitals, medical malpractice payers, health plans, and health 
centers that are subject to NPDB reporting requirements during 
registration renewal.\1\ This will allow the NPDB to continue to assist 
these entities in understanding and meeting their reporting 
requirements.
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    \1\ Unless otherwise noted, the term ``health centers'' refers 
to health centers whose access and reporting obligations are 
addressed in the NPDB statutory and regulatory requirements for 
health care entities. In this document, ``health center'' refers to 
organizations that receive grants under the HRSA Health Center 
Program as authorized under section 330 of the Public Health Service 
Act, as amended (referred to as ``grantees'') and FQHC Look-Alike 
organizations, which meet all the Health Center Program requirements 
but do not receive Health Center Program grants. It does not refer 
to FQHCs that are sponsored by tribal or Urban Indian Health 
Organizations, except for those that receive Health Center Program 
grants.
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    NPDB plans to expand its population of focus to include other 
eligible entities,\2\ including ambulatory surgery centers, group 
medical practices, skilled nursing facilities, mental health centers, 
and other registered entities. Beyond attesting to meeting NPDB 
reporting requirements, entities will also attest to querying and 
confidentiality compliance.
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    \2\ ``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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    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 of 
the NPDB implementation and operation resides in the Bureau of Health 
Workforce, HRSA, HHS.

[[Page 69752]]

    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.
    NPDB outlines specific reporting requirements for hospitals, 
medical malpractice payers, health plans, health centers and other 
eligible entities; per 45 CFR part 60. 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, health centers, and other eligible 
entities are required to attest that they understand and have met their 
responsibility to submit all required reports, queries, and maintain 
confidentiality adherence with NPDB compliance. The Attestation process 
is completely automated through the secure NPDB system (http://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.
    The secure NPDB system currently used by hospitals, medical 
malpractice payers, health plans, health centers, and other entities to 
conduct reporting and querying will not undergo any changes, ensuring 
that these entities are familiar with the interface needed to complete 
the Attestation process. NPDB asks these entities to attest to their 
reporting, querying, and confidentiality compliance every two years. If 
the organization is responsible for privileging or credentialing 
individuals who provide services for other sites, those sites are 
included in the Attestation process.
    Users of the NPDB include reporters (entities that are required to 
submit reports) and queriers (entities that are authorized to request 
for information). Data collected through the Attestation process 
informs the NPDB operations and facilitate the structuring of 
compliance efforts in a manner that is the most effective. The 
Attestation process will also serve as a catalyst to collect meaningful 
data about reporting entities which can later be transformed into 
actionable information and serve as a platform for future initiatives. 
The Attestation forms collect the following information: Information 
regarding sub-sites and entity relationships; contact information for 
the Attesting official; and a statement attesting whether the 
organization adhered to all reporting, querying, and confidentiality 
requirements.
    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, health centers and other eligible entities, are meeting the 
reporting, querying, and confidentiality requirements, and which of 
these entities may require additional outreach and assistance. The 
biennial Attestation process strengthens the robustness of the data in 
the NPDB, improving the accuracy of the query responses for entities 
with access to NPDB reports.
    Below is a summary of the proposed revisions:
    1. Add Query and Confidentiality language to the instruments. 
Beyond attesting to meeting NPDB reporting requirements, entities will 
also attest to querying and confidentiality compliance.
    2. Change Title of ICR.

Current Title: National Practitioner Data Bank Attestation of Reports 
by Hospitals, Medical Malpractice Payers, Health Plans, and Certain 
Other Health Care Entities
Proposed New Title: National Practitioner Data Bank Attestation of 
Reports by Hospitals, Medical Malpractice Payers, Health Plans, Health 
Centers, and Other Eligible Entities

    3. Add NPDB Guidebook definition for Eligible Entities in footnote.
    4. Discontinue use of the Generic Form. Currently Hospitals, 
Medical Malpractice Payers, and Health Plans use the Generic Form to 
attest. This revision includes making each attestation form specific to 
entity type based on reporting/querying requirements.
    5. Revise attestation question so that all entities will receive 
the same question.

A. Current Question for Health Centers

    Has your organization reported all adverse actions taken from Month 
DD, YYYY to Month DD, YYYY affecting the clinical privileges of a 
physician or dentist as defined above?

 Yes, all required reports are submitted
 No, some required reports have not been submitted

    If ``no'', why not? ____

B. Current Question for Hospitals, Health Plans, Medical Malpractice 
Payers

    Has your organization submitted all reports, as required by law, 
from , to  ?

 Yes, all required reports are submitted
 No, some required reports have not been submitted

    If ``no'', why not? ____

C. New Question for All Registered Entities

    Has your organization complied with all NPDB regulatory 
requirements as outlined above?

 Yes
 No

    If ``no'', why not?____

    Likely Respondents: Hospitals, Medical Malpractice Payers, Health 
Plans, Health Centers, and Other Eligible Entities.
    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:

[[Page 69753]]



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                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)       hours \3\
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Authorized Agent Attestation....             350               1             350               1             350
Health Center Attestation.......             650               1             650               1             650
Hospital Attestation............           3,250               1           3,250               1           3,250
Medical Malpractice, Peer Review             250               1             250               1             250
 Organization, or Private
 Accreditation Organization
 Attestation....................
Other Eligible Entity                      7,100               1           7,100               1           7,100
 Attestation....................
     Agencies
     administering federal
     programs, including
     contract entities..........
     Federal law
     enforcement officials and
     agencies (including DEA,
     HHS OIG, and federal
     prosecutors)...............
     Federal licensing
     or certification agencies..
     Health Plans.......
     Other health care
     entities with formal peer
     review.....................
     Other Health care
     service providers..........
     Professional
     Societies with formal peer
     review.....................
     State agencies
     administering or
     supervising state programs.
     State law or fraud
     enforcement agencies
     (including Medicaid fraud
     control units & state
     prosecutors)...............
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        Total...................          11,600  ..............          11,600  ..............          11,600
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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.
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    \3\ There are approximately 700 authorized agents; 1,300 health 
centers; 6,500 hospitals; 500 medical malpractice payers, peer 
review organizations, and private accreditation organizations; and 
14,200 other eligible entities, for an estimated total of 23,200 
registered entities currently in attestation or scheduled for 
attestation with the NPDB. However, the reporting entities may 
include multiple sites that are registered independently in the 
system, thereby increasing the total number of respondents. Given 
that entities will only be required to complete attestation 
biennially, these estimates are divided in half for the annualized 
burden hours.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-27395 Filed 12-18-19; 8:45 am]
 BILLING CODE 4165-15-P