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, 69751-69753 [2019-27395]
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Federal Register / Vol. 84, No. 244 / Thursday, December 19, 2019 / Notices
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collections of information in 21 CFR
part 312 for investigational new drug
applications and 21 CFR part 314 for
new drug applications have been
approved under OMB control numbers
0910–0014 and 0910–0001, respectively.
The collections of information in 21
CFR part 601 for biologics license
applications have been approved under
OMB control number 0910–0338. The
collections of information in 21 CFR
part 814, subparts A through E, for
premarket approval applications have
been approved under OMB control
number 0910–0231. The collections of
information in section 510(k) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360(k)), subpart E for 510(k)
notifications, have been approved under
OMB control number 0910–0120. The
collections of information in the
guidance for industry and FDA staff
entitled ‘‘De Novo Classification Process
(Evaluation of Automatic Class III
Designation)’’ have been approved
under OMB control number 0910–0844.
The collection of information in 21 CFR
part 4 has been approved under the
underlying current good manufacturing
process regulations for drugs, devices,
and biological products, including
current good tissue practices for human
cells, tissues, and cellular and tissuebased products, found at parts 211, 820,
600 through 680, and 1271 (21 CFR
parts 211, 820, 600 through 680, and
1271), which have already been
approved and are in effect. The
provisions of part 211 are approved
under OMB control number 0910–0139.
The provisions of part 820 are approved
under OMB control number 0910–0073.
The provisions of parts 606, 640, and
660 are approved under OMB control
number 0910–0116. The provisions of
part 610 are approved under OMB
control numbers 0910–0116 and 0910–
0338 (also for part 680). The provisions
of part 1271, subparts C and D, are
approved under OMB control number
0910–0543.
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III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emitting-
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Jkt 250001
products, or https://
www.regulations.gov.
Dated: December 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27354 Filed 12–18–19; 8:45 am]
BILLING CODE 4164–01–P
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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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.
SUMMARY:
Submit your comments to
paperwork@hrsa.gov 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 paperwork@hrsa.gov
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
ADDRESSES:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
69751
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.
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.
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.
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.
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.
E:\FR\FM\19DEN1.SGM
19DEN1
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69752
Federal Register / Vol. 84, No. 244 / Thursday, December 19, 2019 / Notices
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, healthrelated 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 https://
www.npdb.hrsa.gov/resources/about
Guidebooks.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 (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.
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
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19:13 Dec 18, 2019
Jkt 250001
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 subsites 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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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? llll
B. Current Question for Hospitals,
Health Plans, Medical Malpractice
Payers
Has your organization submitted all
reports, as required by law, from <MM
DD,YYYY>, to <MM DD, YYYY> ?
• Yes, all required reports are submitted
• No, some required reports have not
been submitted
If ‘‘no’’, why not? llll
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?llll
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:
E:\FR\FM\19DEN1.SGM
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69753
Federal Register / Vol. 84, No. 244 / Thursday, December 19, 2019 / Notices
Number of
respondents
Form name
Authorized Agent Attestation ...............................................
Health Center Attestation .....................................................
Hospital Attestation ..............................................................
Medical Malpractice, Peer Review Organization, or Private
Accreditation Organization Attestation .............................
Other Eligible Entity 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).
Total .......................................................................
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. 2019–27395 Filed 12–18–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the National Advisory
Council on the National Health Service
Corps
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
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AGENCY:
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.
VerDate Sep<11>2014
19:13 Dec 18, 2019
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ACTION:
Number of
responses per
respondent
Total burden
hours 3
1
1
1
350
650
3,250
1
1
1
350
650
3,250
250
7,100
1
1
250
7,100
1
1
250
7,100
11,600
........................
11,600
........................
11,600
Notice.
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
National Advisory Council on the
National Health Service Corps
(NACNHSC) will hold public meetings
for the 2020 calendar year (CY).
Information about NACNHSC, agendas,
and materials for these meetings can be
found on the NACNHSC website at:
https://nhsc.hrsa.gov/nac/
meetings.html.
DATES:
• January 14, 2020, 9:00 a.m.–5:00
p.m.; January 15, 2020, 9:00 a.m.–2:00
p.m. Eastern Time (E.T.)—In-Person and
Webinar;
• March 10, 2020, 9:00 a.m.–5:00
p.m.; March 11, 2020, 9:00 a.m.–2:00
p.m. E.T.—Webinar;
• June 16, 2020, 9:00 a.m.–5:00 p.m.;
June 17, 2020, 9:00 a.m.–2:00 p.m.
E.T.—In-Person and Webinar;
• November 5, 2020, 9:00 a.m.–5:00
p.m.; November 6, 2020, 9:00 a.m.–2:00
p.m. E.T.—In-Person and Webinar.
ADDRESSES: Meetings may be held inperson, by teleconference, and/or Adobe
Connect webinar. In-person NACNHSC
meetings will be held at 5600 Fishers
Lane, Rockville, Maryland 20857.
Instructions for joining the meetings
either in person or remotely will be
posted on the NACNHSC website 30
business days before the date of the
meeting. For meeting information
updates, go to the NACNHSC website
meeting page at https://nhsc.hrsa.gov/
nac/meetings.html.
FOR FURTHER INFORMATION CONTACT:
Diane Fabiyi-King, Designated Federal
Frm 00034
Average
burden per
response
(in hours)
350
650
3,250
SUMMARY:
PO 00000
Total
responses
Fmt 4703
Sfmt 4703
Official (DFO), Division of National
Health Service Corps, HRSA. Address:
5600 Fishers Lane, Room 14N110,
Rockville, Maryland 20857; phone (301)
443–3609; or BHWNACNHSC@hrsa.gov.
The
NACNHSC consults, advises, and makes
annual recommendations to the
Secretary of HHS and the Administrator
of HRSA with respect to their NHSC
related responsibilities under Subpart II,
Part D of Title III of the Public Health
Service Act (42 U.S.C. 254d–254k), as
amended, to designate areas of the
United States with health professional
shortages and assign National Health
Service Corps clinicians to improve the
delivery of health services in health
professional shortage areas. Since
priorities dictate meeting times, be
advised that times and agenda items are
subject to change. CY 2020 meetings
and agenda items may include, but are
not limited to, the identification of
NHSC priorities for future program
issues and concerns; proposed policy
changes by using the varying levels of
expertise represented on NACNHSC to
advise on specific program areas;
updates from clinician workforce
experts; and education and practice
improvement in the training
development of primary care clinicians.
More general items may include
presentations and discussions on the
current and emerging needs of health
workforce; public health priorities;
healthcare access and evaluation;
NHSC-approved sites; HRSA priorities
and other federal health workforce and
education programs that impact the
NHSC.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19DEN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 https://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 (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.
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
