[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37613-37614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13735]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995), the Health Resources and Services 
Administration (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 Information Collection Request must be received 
no later than August 9, 2016.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14A39, 5600 Fishers 
Lane, Rockville, MD 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 the HRSA 
Information Collection Clearance Officer at (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information collection request title 
for reference.
    Information Collection Request Title: National Practitioner Data 
Bank (NPDB) Attestation of Reports by Hospitals, Medical Malpractice 
Payers, Health Plans, and Health Centers.
    OMB No. 0915-xxxx--New.
    Abstract: The NPDB plans to collect data from hospitals, medical 
malpractice payers, health plans, and certain other health care 
entities \1\ that are subject to NPDB reporting requirements to assist 
these entities in understanding and meeting their reporting 
requirements to the NPDB. The NPDB currently collects similar data from 
state licensing boards on a regular basis, and this information 
collection request would expand beyond current reporting activities to 
include hospitals, medical malpractice payers, health plans, and 
certain health care entities.
---------------------------------------------------------------------------

    \1\ Unless otherwise noted, the term ``health care entities'' 
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 Federally 
Qualified Health Center (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.
---------------------------------------------------------------------------

    The 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 for 
NPDB implementation and operation resides in the Bureau of Health 
Workforce, Health Resources and Services Administration, Department of 
Health and Human Services (HHS).
    The 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.
    The NPDB outlines specific reporting requirements for hospitals, 
medical malpractice payers, health plans, and health care entities; per 
45 CFR 60.7, 60.12, 60.14, 60.15, and 60.16. 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, and certain other health entities 
will be required to attest that they understand and have met their 
responsibility to submit all required reports to the NPDB. The 
Attestation process will be 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.
    Although the Attestation process and forms are new, the secure NPDB 
system currently used by hospitals, medical malpractice payers, health 
plans, and health care entities to conduct reporting and querying will 
not change, ensuring that these entities are familiar with the 
interface needed to complete the Attestation process. NPDB will ask 
these entities to attest their reporting compliance every 2 years. If 
the organization is responsible for privileging or credentialing 
individuals who provide services for other sites, those sites will be 
included in the Attestation process.
    The Attestation forms will collect the following information: (1) 
Information regarding sub-sites and entity relationships; (2) contact 
information for the Attesting Official; and (3) a statement attesting 
whether or not all required reports have been submitted.
    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, and health care entities are meeting the reporting requirements, 
and which of

[[Page 37614]]

these entities may require additional outreach and assistance. The 
Attestation process will strengthen the robustness of the data in the 
NPDB, improving the accuracy of query responses for entities with 
access to NPDB reports.
    Likely Respondents: Hospitals medical malpractice payers, health 
plans, health care entities, and their representatives.
    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 attesting 
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.
    Total Estimated Annualized burden hours:

----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Health Care Entity Attestation..           3,000               1           3,000               1           3,000
Medical Malpractice Payer                    750               1             750               1             750
 Attestation....................
Health Plan Attestation.........           1,500               1           1,500               1           1,500
Hospital Attestation............           7,500               1           7,500               1           7,500
                                 -------------------------------------------------------------------------------
    Total.......................      \2\ 12,750  ..............          12,750  ..............          12,750
----------------------------------------------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \2\ There are approximately 6,800 hospitals, 575 medical 
malpractice payers, 1,400 health plans, and 2,200 health centers 
registered 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. 
Therefore, we estimate there will be 7,500 respondents for 
hospitals, 750 respondents for medical malpractice payers, 1,500 
respondents for health plans, and 3,000 respondents for health 
centers for 12,750 total respondents.

Jason E. Bennett,
Director, Division of Executive Secretariat.
[FR Doc. 2016-13735 Filed 6-9-16; 8:45 am]
 BILLING CODE 4165-15-P