Federal Register, Volume 75, Number 18, January 28, 2010, Pages 4469-4682 Page: 4,668

                                
Federal Register/Vol. 75, No. 18/Thursday, January 28, 2010/Rules and Regulations

non-renewals of licenses, including
those occasioned by non-payment of
licensure fees, a change to inactive
status, or due to retirement.
Response: We disagree with these
comments. Section 1921 and section
1128E both require reporting of any loss
of license, including a loss for the
reason of a voluntary surrender. During
the public comment period for the
section 1128E proposed rule, we
received public comments concerning
this same definition of voluntary
surrender. Commenters, particularly
licensing authorities, expressed concern
regarding the volume of reports that
would have to be submitted if all
surrenders of license-including those
due to retirement or non-payment of
fees-were reportable and the value of
these non-disciplinary related
surrenders to queriers. At that time, it
was determined that voluntary
surrenders for reasons such as
retirement and non-payment of
licensure renewal fees would provide
little value to Data Bank users and that
such actions would not be collected.
Distinctions between voluntary and
involuntary surrenders have not been an
issue for those reporting such actions to
the HIPDB, and we do not think such
distinctions are warranted at this time.
To ensure consistency between section
1921 and HIPDB reporting
requirements, we will maintain this
definition of voluntary surrender for
both Data Banks.
Comment: One commenter expressed
concern about a potential conflict
between the reporting of a negative
action or finding that under State law is
publicly available information and a
"voluntary surrender after a notification
of investigation or a formal official
request" to surrender the license. The
commenter believed that many
reportable voluntary surrenders may be
based on non-public investigative
information and, therefore, not
reportable. The commenter requested
clarification of the definition of a
reportable voluntary surrender to
include surrenders regardless of
whether they are based upon a
notification of investigation, or request,
or agreement that is publicly available.
Response: We believe there is no
conflict between reporting a negative
action or finding that is publicly
available and a voluntary surrender that
is based on information that is not
publicly available. Voluntary surrenders
are reportable even if the underlying
reasons for the surrender are not public
information. However, voluntary
surrenders relating to retirement, non-
payment of licensure renewal fees, and

an investigation in progress, are not
reportable.
We did not receive any comments on
the definitions of the terms "affiliated or
associated," "organization type," or
"Quality Improvement Organization."
How Information Must Be Reported
( 60.4)
Comment: We received several
comments supporting the integration of
the electronic reporting and querying
system for the NPDB and the HIPDB,
which enables reporting entities to
submit a single adverse action to both
Data Banks, as appropriate. One
commenter, however, questioned the
need for two systems if all of the
information is automatically sent to
both with a single query or report
submission.
Response: The NPDB and the HIPDB
are separate and distinct repositories,
with different types of reportable
actions contained in each, as well as
different sets of authorized queriers.
However, this distinction
notwithstanding, the NPDB and the
HIPDB form one integrated system.
Within this integrated system, an action
reportable to both the NPDB, including
section 1921 and the HIPDB, will only
need to be reported once. The system
will subsequently store the report
according to the appropriate statutory
authority. Additionally, an eligible
querier that is registered to have access
to information under both Data Banks
can query for information through a
single request.
When Information Must Be Reported
( 60.5)
Comment: One commenter stated the
15-day timeframe to report to a State is
not a reasonable amount of time for
reporting information. We also received
comments expressing concern over the
need to report to individual States
rather than directly to the NPDB.
Response: We feel that the 15-day
timeframe is a reasonable amount of
time for reporting information.
Currently, health care entities have 15
days to report actions to the Data Banks.
This procedure has been in place since
the implementation of the NPDB and we
have not received notice of any
concerns from users. Consequently, we
feel it is appropriate to use this
timeframe with section 1921. Further,
since the development of electronic
reporting technology, entities now
submit reports directly to the NPDB
using the Data Bank's electronic
reporting system. The Data Banks'
electronic reporting system enables
reporting entities to satisfy reporting

obligations to State licensing authorities

by automatically providing a copy of the
report for submission via mail or fax to
the appropriate State Board.
Comment: One commenter requested
clarification of the penalties for failure
to report to the NPDB.
Response: Current regulations specify
the penalties for failing to report
information to the NPDB under the
HCQIA. For State licensing authorities
that fail to report licensing actions,
 60.8 (c) states that "[i]f, after notice of
noncompliance and providing
opportunity to correct noncompliance,
the Secretary determines that a Board
has failed to submit a report as required
by this section, the Secretary will
designate another qualified entity for
the reporting of information under
 60.9" (redesignated as  60.11). There
are no additional penalties specified
under section 1921 for failure to report.
Reporting Errors, Omissions, and
Revisions ( 60.6)
Comment: One commenter questioned
how HRSA would handle reports on
hospital subjects that changed
ownership or discontinued operation or
services. The commenter suggested that
HRSA should specify how a report
would be updated when the information
is no longer meaningful given a change
in hospital circumstances.
Response: The Data Banks provide
several methods to update identifying
information. If the subject of a report
determines that reported information
concerning the subject is no longer
accurate, the subject should first contact
the reporting entity to request that the
entity submit a correction report with
the updated information. Also, the
subject may provide more current
information, such as a name change, to
the Data Banks. In addition, the subject
may submit a subject statement for the
report. This statement could note the
change in ownership or other change in
status since the report was filed.
However, reporting entities are
responsible for ensuring the accuracy of
the information contained in any report
they submit.
Reporting Licensure Actions Taken by
Boards of Medical Examiners ( 60.8)
Comment: Two commenters requested
that  60.8 and 60.9 of the NPDB
regulations be revised to include other
health care practitioners in addition to
physicians and dentists. These
commenters requested that adverse
clinical privileges actions taken against
other health care practitioners be made
mandatory instead of voluntary. One
commenter stated that the current
regulations do not adequately protect

4668

change to inactive status, if there is not

consumers and health care facilities