Health Care Fraud and Abuse Data Collection Program: Reporting of Final Adverse Actions; Correction, 53953-53954 [05-17915]
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Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’‘‘Policies that have tribal
implications’’ is defined in the
Executive Order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
IX. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
Commodity
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 22, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.436 is amended by
removing the commodity potato from
the table in paragraph (a); by
alphabetically adding new commodities
to the table in paragraph (a); and by
adding paragraph (c) to read as follows:
I
§ 180.436 Cyfluthrin; tolerances for
residues.
(a) *
*
*
Parts per million
Almond, hulls .......................................................................................
Brassica, leafy greens, subgroup 5B ..................................................
Fruit, pome, group 11 ..........................................................................
Fruit, stone, group 12 ..........................................................................
Grape ...................................................................................................
Grape, raisin ........................................................................................
Nut, tree, group 14 ..............................................................................
Pea and bean, dried shelled, except soybean, subgroup 6C .............
Peanut ..................................................................................................
Peanut, hay ..........................................................................................
Pistachio ..............................................................................................
Turnips, greens ....................................................................................
Vegetable, cucurbit, group 9 ...............................................................
Vegetable, fruiting, group 8 .................................................................
Vegetable, leafy greens, except Brassica, group 4 ............................
Vegetable, tuberous and corm, subgroup 1C .....................................
Wheat, forage ......................................................................................
Wheat, hay ...........................................................................................
Wheat, straw ........................................................................................
*
*
*
*
*
(c) Tolerances with regional
registrations. Tolerances with regional
registration, as defined in § 180.1(n), are
established for residues of cyfluthrin in
or on the following raw agricultural
commodities:
Commodity
Parts per million
Grass, forage ..................
Grass, hay ......................
*
*
*
*
6.0
8.0
*
[FR Doc. 05–17823 Filed 9–12–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Office of Inspector General
45 CFR Part 61
RIN 0906–AA46
Health Care Fraud and Abuse Data
Collection Program: Reporting of Final
Adverse Actions; Correction
Office of Inspector General
(OIG), HHS.
ACTION: Correction amendment.
AGENCY:
PO 00000
Frm 00053
Fmt 4700
Sfmt 4700
SUMMARY: This document corrects the
final regulations establishing the
Healthcare Integrity and Protection Data
Bank (HIPDB), the national health care
fraud and abuse data collection program
for the reporting and disclosing of
certain adverse actions taken against
health care providers, suppliers and
practitioners and for maintaining a data
base of final adverse actions taken
against health care providers, suppliers
and practitioners. In the implementing
HIPDB regulations published in the
Federal Register on October 26, 1999
(64 FR 57740), an inadvertent error
appeared in the regulations text
concerning the definition of the term
E:\FR\FM\13SER1.SGM
13SER1
53954
Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Rules and Regulations
‘‘any other negative action or finding.’’
As a result, we are correcting the
definition of the term to assure the
technical correctness of these
regulations.
EFFECTIVE DATE: September 13, 2005.
FOR FURTHER INFORMATION CONTACT: Joel
Schaer, OIG Regulations Officer, Office
of External Affairs, (202) 619–0089.
SUPPLEMENTARY INFORMATION: On
October 26, 1999, the HHS Office of
Inspector General (OIG) issued final
regulations (64 FR 57740) that
established a national health care fraud
and abuse data collection program—the
Healthcare Integrity and Protection Data
Bank (HIPDB)—for the reporting and
disclosing of certain final adverse
actions taken against health care
providers, suppliers and practitioners,
and for maintaining a data base of final
adverse actions taken against health care
providers, suppliers and practitioners.
The final rule established a new 45 CFR
part 61 to implement the requirements
for reporting of specific data elements
to, and procedures for obtaining
information from, the HIPDB. In that
final rule, an inadvertent error appeared
in § 61.3—the definitions section of the
regulations—and is now being
corrected.
Specifically, § 61.3 expanded on
previous regulatory definitions and
provided additional examples of the
scope of various terms set forth in the
statute. On page 57755 of the preamble,
summarizing the various revisions being
made to the final rule, we indicated that
with respect to the definition for the
term ‘‘any other negative action or
finding’’ there are certain kinds of
actions or findings that would not meet
the intent of the statute and not be
reportable. We cited, as an example,
administrative actions, such as limited
training permits, limited licenses for
telemedicine, fines or citations that do
not restrict a practitioner’s practice, or
personnel actions for tardiness, that
were not within the range of actions
intended by the statute. As a result, we
agreed to add a clarifying phrase to this
term. The revised definition would
exclude administrative fines or
citations, corrective action plans and
other personnel actions, unless they are
(1) connected to the billing, provision or
delivery of health care services, and (2)
taken in conjunction with other
licensure or certification actions such as
revocation, suspension, censure,
reprimand, probation, or surrender.
However, we inadvertently omitted this
clarifying language to the regulations
text of the rule itself. Therefore, to be
consistent with the intended
clarification and the overall intent of the
VerDate Aug<18>2005
15:30 Sep 12, 2005
Jkt 205001
final rulemaking, we proposed
correcting this inadvertent error in the
definition of the term ‘‘any other
negative action or finding’’ that
appeared on page 57759 in the October
26, 1999 final regulations to include this
additional clarifying language.
Proposed Correction Notice and
Response to Comments
On June 24, 2005, OIG published a
proposed notice (70 FR 36554) setting
forth the intended correction to the
definition of the term ‘‘any other
negative action or finding’’ in 45 CFR
61.3, and soliciting public comments
regarding our intent to clarify the
existing definition of the term in
accordance with the earlier final
rulemaking.
As a result of that proposed correction
amendment, OIG received two
comments. While one commenter fully
supported our decision to include the
clarifying language to ensure technical
correctness of the regulations, a second
commenter mistakenly interpreted the
clarifying language as narrowing the
regulatory exceptions and was
concerned that the amendatory language
would result in States having to report
a large number of relatively minor
corrective action plan actions that could
unfairly prejudice the party about whom
or which the report was made. In
response to the second commenter’s
concern, we reiterate that a corrective
action plan independent of an adverse
licensing action is not reportable. Only
corrective action plans submitted in
conjunction with a specific adverse
licensing action would be required to be
reported on a single form report. (The
HIPDB report form includes a narrative
description section that is to be used by
the reporting entity to describe the
details of the action. This section of the
report requires the reporter to provide
details about why the action was taken,
as well as other pertinent details, which
may include a corrective action plan or
other remedial steps such as citations or
personnel actions.) This clarifying
language does not result in any
additional reporting requirements on
behalf of the reporting entity.
List of Subjects in 45 CFR Part 61
Billing and transportation services,
Durable medical equipment suppliers
and manufacturers, Health care insurers,
Health maintenance organizations,
Health professions, Home health care
agencies, Hospitals, Penalties,
Pharmaceutical suppliers and
manufacturers, Privacy, Reporting and
recordkeeping requirements, Skilled
nursing facilities.
PO 00000
Frm 00054
Fmt 4700
Sfmt 4700
Accordingly, 45 CFR part 61 is
amended by making the following
correcting amendment:
I
PART 61—HEALTHCARE INTEGRITY
AND PROTECTION DATA BANK FOR
FINAL ADVERSE INFORMATION ON
HEALTH CARE PROVIDERS,
SUPPLIERS AND PRACTITIONERS
1. The authority citation for part 61
continues to read as follows:
I
Authority: 42 U.S.C. 1320a–7e.
2. Section 61.3 is amended by
republishing the introductory text, and
by revising the definition for the term
‘‘Any other negative action or finding’’
to read as follows:
I
§ 61.3
Definitions.
The following definitions apply to
this part:
*
*
*
*
*
Any other negative action or finding
by a Federal or State licensing agency
means any action or finding that under
the State’s law is publicly available
information, and rendered by a
licensing or certification authority,
including but not limited to, limitations
on the scope of practice, liquidations,
injunctions and forfeitures. This
definition also includes final adverse
actions rendered by a Federal or State
licensing or certification authority, such
as exclusions, revocations or suspension
of license or certification that occur in
conjunction with settlements in which
no finding of liability has been made
(although such a settlement itself is not
reportable under the statute). This
definition excludes administrative fines
or citations and corrective action plans
and other personnel actions, unless they
are:
(1) Connected to the delivery of health
care services, and
(2) Taken in conjunction with other
licensure or certification actions such as
revocation, suspension, censure,
reprimand, probation or surrender.
*
*
*
*
*
Dated: September 2, 2005.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. 05–17915 Filed 9–12–05; 8:45 am]
BILLING CODE 4152–01–P
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13SER1
]]>Agencies
[Federal Register Volume 70, Number 176 (Tuesday, September 13, 2005)]
[Rules and Regulations]
[Pages 53953-53954]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17915]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Office of Inspector General
45 CFR Part 61
RIN 0906-AA46
Health Care Fraud and Abuse Data Collection Program: Reporting of
Final Adverse Actions; Correction
AGENCY: Office of Inspector General (OIG), HHS.
ACTION: Correction amendment.
-----------------------------------------------------------------------
SUMMARY: This document corrects the final regulations establishing the
Healthcare Integrity and Protection Data Bank (HIPDB), the national
health care fraud and abuse data collection program for the reporting
and disclosing of certain adverse actions taken against health care
providers, suppliers and practitioners and for maintaining a data base
of final adverse actions taken against health care providers, suppliers
and practitioners. In the implementing HIPDB regulations published in
the Federal Register on October 26, 1999 (64 FR 57740), an inadvertent
error appeared in the regulations text concerning the definition of the
term
[[Page 53954]]
``any other negative action or finding.'' As a result, we are
correcting the definition of the term to assure the technical
correctness of these regulations.
EFFECTIVE DATE: September 13, 2005.
FOR FURTHER INFORMATION CONTACT: Joel Schaer, OIG Regulations Officer,
Office of External Affairs, (202) 619-0089.
SUPPLEMENTARY INFORMATION: On October 26, 1999, the HHS Office of
Inspector General (OIG) issued final regulations (64 FR 57740) that
established a national health care fraud and abuse data collection
program--the Healthcare Integrity and Protection Data Bank (HIPDB)--for
the reporting and disclosing of certain final adverse actions taken
against health care providers, suppliers and practitioners, and for
maintaining a data base of final adverse actions taken against health
care providers, suppliers and practitioners. The final rule established
a new 45 CFR part 61 to implement the requirements for reporting of
specific data elements to, and procedures for obtaining information
from, the HIPDB. In that final rule, an inadvertent error appeared in
Sec. 61.3--the definitions section of the regulations--and is now
being corrected.
Specifically, Sec. 61.3 expanded on previous regulatory
definitions and provided additional examples of the scope of various
terms set forth in the statute. On page 57755 of the preamble,
summarizing the various revisions being made to the final rule, we
indicated that with respect to the definition for the term ``any other
negative action or finding'' there are certain kinds of actions or
findings that would not meet the intent of the statute and not be
reportable. We cited, as an example, administrative actions, such as
limited training permits, limited licenses for telemedicine, fines or
citations that do not restrict a practitioner's practice, or personnel
actions for tardiness, that were not within the range of actions
intended by the statute. As a result, we agreed to add a clarifying
phrase to this term. The revised definition would exclude
administrative fines or citations, corrective action plans and other
personnel actions, unless they are (1) connected to the billing,
provision or delivery of health care services, and (2) taken in
conjunction with other licensure or certification actions such as
revocation, suspension, censure, reprimand, probation, or surrender.
However, we inadvertently omitted this clarifying language to the
regulations text of the rule itself. Therefore, to be consistent with
the intended clarification and the overall intent of the final
rulemaking, we proposed correcting this inadvertent error in the
definition of the term ``any other negative action or finding'' that
appeared on page 57759 in the October 26, 1999 final regulations to
include this additional clarifying language.
Proposed Correction Notice and Response to Comments
On June 24, 2005, OIG published a proposed notice (70 FR 36554)
setting forth the intended correction to the definition of the term
``any other negative action or finding'' in 45 CFR 61.3, and soliciting
public comments regarding our intent to clarify the existing definition
of the term in accordance with the earlier final rulemaking.
As a result of that proposed correction amendment, OIG received two
comments. While one commenter fully supported our decision to include
the clarifying language to ensure technical correctness of the
regulations, a second commenter mistakenly interpreted the clarifying
language as narrowing the regulatory exceptions and was concerned that
the amendatory language would result in States having to report a large
number of relatively minor corrective action plan actions that could
unfairly prejudice the party about whom or which the report was made.
In response to the second commenter's concern, we reiterate that a
corrective action plan independent of an adverse licensing action is
not reportable. Only corrective action plans submitted in conjunction
with a specific adverse licensing action would be required to be
reported on a single form report. (The HIPDB report form includes a
narrative description section that is to be used by the reporting
entity to describe the details of the action. This section of the
report requires the reporter to provide details about why the action
was taken, as well as other pertinent details, which may include a
corrective action plan or other remedial steps such as citations or
personnel actions.) This clarifying language does not result in any
additional reporting requirements on behalf of the reporting entity.
List of Subjects in 45 CFR Part 61
Billing and transportation services, Durable medical equipment
suppliers and manufacturers, Health care insurers, Health maintenance
organizations, Health professions, Home health care agencies,
Hospitals, Penalties, Pharmaceutical suppliers and manufacturers,
Privacy, Reporting and recordkeeping requirements, Skilled nursing
facilities.
0
Accordingly, 45 CFR part 61 is amended by making the following
correcting amendment:
PART 61--HEALTHCARE INTEGRITY AND PROTECTION DATA BANK FOR FINAL
ADVERSE INFORMATION ON HEALTH CARE PROVIDERS, SUPPLIERS AND
PRACTITIONERS
0
1. The authority citation for part 61 continues to read as follows:
Authority: 42 U.S.C. 1320a-7e.
0
2. Section 61.3 is amended by republishing the introductory text, and
by revising the definition for the term ``Any other negative action or
finding'' to read as follows:
Sec. 61.3 Definitions.
The following definitions apply to this part:
* * * * *
Any other negative action or finding by a Federal or State
licensing agency means any action or finding that under the State's law
is publicly available information, and rendered by a licensing or
certification authority, including but not limited to, limitations on
the scope of practice, liquidations, injunctions and forfeitures. This
definition also includes final adverse actions rendered by a Federal or
State licensing or certification authority, such as exclusions,
revocations or suspension of license or certification that occur in
conjunction with settlements in which no finding of liability has been
made (although such a settlement itself is not reportable under the
statute). This definition excludes administrative fines or citations
and corrective action plans and other personnel actions, unless they
are:
(1) Connected to the delivery of health care services, and
(2) Taken in conjunction with other licensure or certification
actions such as revocation, suspension, censure, reprimand, probation
or surrender.
* * * * *
Dated: September 2, 2005.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. 05-17915 Filed 9-12-05; 8:45 am]
BILLING CODE 4152-01-P
