Federal Register, Volume 75, Number 18, January 28, 2010, Pages 4469-4682 Page: 4,670

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

negative actions or findings to all State
agencies responsible for licensing
hospitals and health care entities.
Response: Adopting such a reporting
requirement for private accreditation
entities is unnecessary and would be
overly burdensome. Queriers, including
State licensing authorities, will have
access to negative actions and findings
reported by accreditation entities
through the NPDB, which is a national
repository.
Comment: Two commenters
expressed concern about the reporting
of a narrative description of the act or
omission upon which the reported
action was based. The commenters
requested that HRSA provide detailed
guidance on the type of information to
be included in this narrative
description.
Response: A narrative description of
the act(s) or omission(s) should contain
sufficient specificity to allow a
knowledgeable Data Bank querier to
clearly understand what led to the
reported action or finding and the
seriousness of the act(s) or omission(s).
Narrative information also should be
supported by written documentation,
such as official findings, orders or
minutes. HRSA has provided examples
of acceptable narrative descriptions on
the NPDB Web site (npdb-
hipdb@hrsa.gov), along with guidance
on how to write an acceptable narrative
description and will continue to provide
information as needed.
Comment: One commenter expressed
concern that the proposed  60.10 does
not include the requirement that the
reported action must be the result of
formal proceedings (as defined in  60.3)
and requested that this omission be
corrected in the final rule.
Response: The requirement that an
action must be the result of a formal
proceeding was omitted in error and has
been included in the final rule.
Comment: One commenter asked
whether a hospital would be required to
report its own accreditation
recommendations.
Response: Section 1921 does not
require hospitals or other health care
entities to self-report accreditation
recommendations. In general, only the
entity that takes a reportable action or
finding must report the action or finding
to the NPDB. The subject of the
reportable action does not report the
action.
Requesting Information From the NPDB
( 60.13) [Redesignated]
Comment: Several commenters
questioned whether a hospital is
authorized to query on nurses and other

health care practitioners who are

employed by the hospital. They
believed the proposed rule only
authorizes hospitals to query on
individuals on the medical staff or those
who hold clinical privileges. Another
commenter questioned whether
hospitals had access to section 1921
information at all.
Response: Section 1921 information is
available to hospitals. Section 1921(b)(6)
of the Social Security Act states that this
information is available to "hospitals
and other health care entities * * *
with respect to physicians or other
licensed health care practitioners that
have entered into, or may be entering
into, an employment or affiliation
relationship with, or have applied for
clinical privileges or appointments to
the medical staff of, such hospitals or
other health care entities * * *" The
other licensed health care practitioners
include individuals in professions such
as nursing and physical therapy.
Comment: Several commenters
expressed concern that private
accreditation entities are not authorized
to query and receive section 1921
information, which would support their
evaluations of a health care entity's
performance. Other commenters
supported public access to NPDB
information.
Response: The Secretary is not
authorized to provide private
accreditation entities, other
organizations, or the general public
access to NPDB information.
Comment: We received several
comments questioning the range of law
enforcement agencies permitted to
query the NPDB under the proposed
rule. In particular, commenters
questioned the inclusion in the
proposed rule of certain law
enforcement agencies, such as the
Nuclear Regulatory Commission and the
U.S. Chief of Postal Inspector, not
specifically included in the statute. One
commenter noted that law enforcement
access to section 1921 information
would deter participation in quality and
risk management procedures. We also
received comments requesting that
subjects of reports be informed when
law enforcement agencies receive a copy
of their report, and that law enforcement
agencies should be required to state the
purpose of their query and not use the
NPDB to circumvent standard criminal
investigative procedures.
Response: Section 1921(b) of the
Social Security Act authorizes the
Secretary to release information
collected under the statute to "the
Attorney General and such other law
enforcement officials as the Secretary
deems appropriate." The list provided in

the proposed rule of agencies authorized

to receive section 1921 information
under these provisions is not considered
to be exhaustive. Each of the listed
agencies, however, meets the
qualifications described in the statute.
For example, the U.S. Chief of Postal
Inspector and State law enforcement
agencies play a major role in
investigating health care fraud and
abuse in government health care
programs. The Nuclear Regulatory
Commission enforces regulations
governing the medical use of nuclear
materials and also licenses physicians,
clinical laboratories and hospitals to
possess and use nuclear byproduct
materials. These agencies will not have
access to professional review actions or
medical malpractice information in the
NPDB, but only section 1921 reports, so
we do not believe their access should
have any impact on quality and risk
management activities.
Currently, all NPDB and HIPDB
queriers are required to provide a reason
for their information request on a
particular subject. Also, the system
records the name of each querying
entity that has requested and received a
copy of a report, information that is
available to the subject of that report
upon request, with the exception of
queries submitted by law enforcement
agencies to the HIPDB. Consistent with
what was done with the HIPDB, HRSA
will be seeking an exemption to protect
from release law enforcement queries
for section 1921 information. This is
necessary in order to protect the
confidentiality and integrity of
investigations by law enforcement.
Confidentiality of National Practitioner
Data Bank Information ( 60.15)
Comment: One commenter expressed
concern that NPDB information may be
misused or misinterpreted. The
commenter stated that punishment for
improper access to or use of NPDB
information should be greater than the
penalties for failing to report mandatory
actions. Other commenters expressed
concern that information may be stored
in the wrong Data Bank and requested
assurances that Data Bank information
is secure.
Response: Information reported to the
NPDB is considered confidential and
access to and use of the information is
restricted. As stated in  60.15, "persons
who, and entities which, receive
information from the NPDB either
directly or from another party must use
it solely with respect to the purpose for
which it was provided." Both improper
use of and access to the NPDB may
result in a CMP of up to $11,000 for

each violation.

4670