Testimony by Employees and the Production of Documents in Proceedings Where the United States Is Not a Party, 53148-53151 [E8-21113]
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53148
Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Rules and Regulations
A deed dated March 18, 2005 contains
the appropriate use restrictions for the
11-acre portion of Parcel B. The
restrictions listed in the deed include
restrictions on groundwater use,
restrictions limiting the use of the
property, restrictions on land
disturbance, and limitations on
activities to protect the remedy. The
deed with the use restrictions are
institutional controls.
For Parcel C the current owner of the
11-acre portion of Parcel B also bought
Parcel C to maintain the property as
open space. Parcels B and C are adjacent
to one another. A deed dated July 10,
2006 contains restrictions on the use of
the parcel consistent with the UAO. The
restrictions listed in the deed include
restrictions on groundwater use,
restrictions limiting the use of the
property, restrictions on land
disturbance, and limitations on
activities to protect the remedy. The
deed with the use restrictions are
institutional controls.
Regarding Parcel D, the owner of
Parcel D signed a letter agreement dated
August 14, 2002 with the UAO
Respondents granting the Respondents
access to install a sentinel well and to
collect groundwater samples. The letter
agreement also provides for
groundwater use restrictions and
prohibitions on interfering with the
well. The letter agreement is an
institutional control.
jlentini on PROD1PC65 with RULES
Five-Year Review
Since the remedy for the Site utilized
containment of the hazardous materials
as a method to reduce risk, EPA will
conduct five-year reviews to insure that
the remedy is functioning as designed
and preventing exposure to human
health and the environment. EPA
completed the first statutory Five-Year
Review on August 2, 2005 and has
determined that the remedy for Berks
Landfill remains protective of human
health and the environment. EPA plans
to complete the next five-year review by
August, 2010.
Community Involvement
To ensure that the community was
well informed about activities at the
Site, a series of outreach activities were
performed. Public meetings at key
points in the remedial process were
held such as a meeting on the proposed
remedy in 1997 and the construction of
the remedy in 2000. Since then, in 2005
as part of the five-year review, EPA
placed an advertisement in the Reading
Eagle and mailed a fact sheet notifying
residents of the five-year review. In
addition, residents whose water is
tested receive annual information on
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their well water test results. As part of
the deletion, EPA will place an
advertisement in the local paper
notifying the community of the public
comment period, the process for
submitting comments, and location of
the deletion docket.
Determination That the Site Meets the
Criteria for Deletion in the NCP
This Site meets all the requirements
in the NCP and the criteria specified in
OSWER Directive 9320.2–09–A–P, Close
Out Procedures for National Priorities
List Sites. Specifically, sampling
performed during operation,
maintenance, and monitoring verifies
the Site has achieved the ROD remedial
action objective that no site-related
contaminants exceed MCLs off-site and
that all components of the remedy
selected by EPA in the ROD have been
implemented. Operation, maintenance,
and monitoring are, and will continue to
be, performed by the Respondents
pursuant to the 1998 UAO.
Dated: September 5, 2008.
Donald S. Welsh,
Regional Administrator, Region III.
For the reasons set out in this
document, 40 CFR part 300 is amended
as follows:
■
PART 300—[AMENDED]
1. The authority citation for part 300
continues to read as follows:
■
Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C.
9601–9657; E.O. 12777, 56 FR 54757, 3 CFR,
1991 Comp., p. 351; E.O. 12580, 52 FR 2923;
3 CFR, 1987 Comp., p. 193.
2. Table 1 of Appendix B to part 300
is amended by removing the entry under
Pennsylvania for ‘‘Berks Landfill’’,
‘‘Spring Township’’.
■
[FR Doc. E8–21305 Filed 9–12–08; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
V. Deletion Action
The EPA, with concurrence of the
Commonwealth through the PADEP, has
determined that all appropriate
response actions under CERCLA, other
than operation, maintenance, and
monitoring and five-year reviews, have
been completed. Therefore, EPA is
deleting the Site from the NPL.
Because EPA considers this action to
be noncontroversial and routine, EPA is
taking it without prior publication. This
action will be effective November 14,
2008 unless EPA receives adverse
comments by October 15, 2008. If
adverse comments are received within
the 30-day public comment period, EPA
will publish a timely withdrawal of this
direct final notice of deletion before the
effective date of the deletion, and it will
not take effect. EPA will prepare a
response to comments and continue
with the deletion process on the basis of
the notice of intent to delete and the
comments already received. There will
be no additional opportunity to
comment.
List of Subjects in 40 CFR Part 300
Environmental protection, Air
pollution control, Chemicals, Hazardous
waste, Hazardous substances,
Intergovernmental relations, Penalties,
Reporting and recordkeeping
requirements, Superfund, Water
pollution control, Water supply.
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45 CFR Part 2
Testimony by Employees and the
Production of Documents in
Proceedings Where the United States
Is Not a Party
Department of Health and
Human Services.
ACTION: Final rule.
AGENCY:
SUMMARY: This rule amends Part 2 of
Title 45 of the Code of Federal
Regulations, which provides that
employees and former employees of the
Department of Health and Human
Services (HHS or Department) may not
provide testimony as part of their
official duties in litigation where the
United States or a federal agency is not
a party, without the approval of the
head of the agency. The purpose of
these amendments is to modify the
definition of ‘‘employee’’ contained in
45 CFR part 2. Under these
amendments, the definition of employee
will be revised to reflect changes in
Medicare contracting, including changes
brought about by the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173). In addition, the definition
of employee will be modified to include
employees of a state agency performing
survey, certification, or enforcement
functions under Title XVIII of the Social
Security Act or Section 353 of the
Public Health Service Act. Further, the
definition of employee with respect to
employees of entities covered by the
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Federally Supported Health Centers
Assistance Act, as amended, 42 U.S.C.
233(g)–(n) (FSHCAA), will be limited to
testimony requested in medical
malpractice tort litigation which relates
to medical functions performed at a
time when the center was covered under
FSHCAA.
DATES: Effective Date: October 15, 2008.
FOR FURTHER INFORMATION CONTACT:
Jeffrey S. Davis, Associate General
Counsel, General Law Division, Office
of the General Counsel, Department of
Health and Human Services, 330
Independence Ave., SW., Room 4760
Cohen Bldg., Washington, DC 20201,
Telephone Number 202–619–0150.
SUPPLEMENTARY INFORMATION: In 1987,
the Department of Health and Human
Services published regulations
addressing the issue of the increasing
number of requests for the testimony of
Department employees in litigation
involving only private parties and not
the United States. The regulations
generally prohibit an employee or
former employee of the Department
from giving testimony concerning
information acquired in the course of
performing official duties or because of
such person’s official capacity, except
where the relevant agency head
determines that the appearance would
promote the objectives of the
Department.
These amendments are designed to
address changes in Medicare
contracting, including changes brought
about by the MMA. The amendments
also address involvement of the
Department in matters in which parties
request testimony or documents from
employees of state survey agencies or
contractors that carry out survey,
certification, or enforcement activities
for the Medicare and CLIA programs.
Finally, these amendments address the
involvement of the Department in cases
other than medical malpractice matters
where parties request testimony from
any current or former employee or
contractor of an entity covered by the
FSHCAA.
Section 911 of the MMA added
section 1874A to the Social Security Act
(SSA) and took the separate authorities
under which the Centers for Medicare &
Medicaid Services (CMS) contracted
with intermediaries and carriers and
consolidated them into a single
authority for a new type of contractor,
the Medicare Administrative Contractor
(MAC). See MMA section 911. Under
section 911, the Secretary may enter
into contracts with any eligible entity to
serve as a MAC with respect to the
performance of the core Medicare
administrative functions listed at SSA
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section 1874A(a)(4). Thus, in the
contracting environment created by the
MMA, MACs perform functions once
performed solely by intermediaries and
carriers. Currently, CMS has agreements
with intermediaries, carriers and MACs
to make Medicare payments for health
care items and services. Furthermore,
under section 911(e) of the MMA, any
reference to a carrier or intermediary
under title XI or XVIII of the Social
Security Act (or any regulation, manual
instruction, interpretative rule,
statement of policy, or guideline issued
to carry out these titles) shall be deemed
a reference to a MAC.
Furthermore, historically, carriers and
intermediaries also carried out all
Medicare program integrity activities,
such as cost report audits and medical,
utilization, and fraud reviews. However,
CMS has begun contracting with
Program Safeguard Contractors (PSCs)
and Recovery Audit Contractors (RACs)
to perform program integrity activities,
see SSA section 1893, although
intermediaries and carriers continue to
carry out many program integrity
functions. There is substantial
functional overlap between the
functions that are performed by PSCs
and RACs and the program integrity
activities that are now, or were once,
carried out by carriers and
intermediaries.
Accordingly, we are amending the
definition of ‘‘employee’’ in these
regulations to include the employees of
contractors that perform the core
Medicare administrative functions listed
at SSA sections 1874A(a)(4) and 1893.
Under such definition, these regulations
cover intermediaries, carriers, MACs,
PSCs and RACs, and any successor
entities that perform the functions listed
in the amended definition. Not only
does this definition reflect the more
flexible contracting procedures created
by the MMA, but a functional definition
of ‘‘employee’’ also limits the need to
amend these regulations again in the
event Congress further modifies the
Medicare contracting nomenclature
through future legislation.
The second amendment concerns
requests for testimony and documents of
employees of contractors,
subcontractors, and state survey
agencies that carry out many of the
Department’s survey, certification, and
enforcement activities. Section 1864 of
the Social Security Act provides that the
Secretary shall enter into agreements
with states under which appropriate
state or local survey agencies determine
whether providers meet Medicare
conditions of participation, suppliers
meet Medicare conditions of coverage,
and rural health clinics meet Medicare
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53149
conditions of certification. Furthermore,
under section 353(o) of the Public
Health Service Act, the Secretary is
permitted to use the services of state
agencies to carry out his responsibilities
under the Clinical Laboratory
Improvement Act Amendments of 1988
(CLIA). Thus, employees of state survey
agencies carry out federal functions for
both the Medicare and CLIA programs.
In addition, contractors of the
Department under certain circumstances
survey and certify providers and
suppliers. Contractors of the Department
also perform validation surveys to
ensure that state survey agencies and
deeming authorities satisfactorily
perform their survey, certification, and
enforcement responsibilities.
Parties in private litigation frequently
request testimony and documents from
employees of contractors,
subcontractors, and state survey
agencies that perform survey,
certification, and enforcement functions
under the Medicare and CLIA programs.
These requests are especially prevalent
in medical malpractice litigation.
Although any specific request for
testimony or documents may not be
unduly burdensome, the requests divert
employees from their federal survey,
certification, and enforcement
responsibilities. The cumulative effect
of these requests can impede these
activities. Moreover, we believe that
information gathered during these
federal activities is federal information
and may be protected by governmental
privileges. Therefore, we are amending
the definition of ‘‘employee’’ in these
regulations to include employees of
contractors, subcontractors, and state
survey agencies that perform survey,
certification, or enforcement activities
under the Medicare and CLIA programs.
We recognize that employees of state
survey agencies may have dual roles.
These employees perform activities for
the Medicare and CLIA programs, but
also have survey, certification, and
enforcement responsibilities with
respect to state requirements. For
example, it is our understanding that
state survey agencies commonly survey
skilled nursing facilities for compliance
with both federal and state requirements
during a single visit. Under 45 CFR
2.1(a), the Department’s regulations
apply only to information acquired in
the course of performing official duties
or because of the employee’s official
capacity with the Department.
Therefore, these regulations will apply
to requests for testimony or documents
from an employee of a contractor,
subcontractor, or state agency only to
the extent the information was acquired
in the course of performing survey,
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Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Rules and Regulations
certification, or enforcement functions
under Title XVIII of the Social Security
Act or section 353 of the Public Health
Service Act and regardless of whether
documents are also relevant to the
state’s activities.
The third amendment addresses the
increasing frequency of requests to the
Department in cases other than medical
malpractice matters for employees and
qualified contractors of entities covered
under the FSHCAA to provide
testimony. The FSHCAA provides that,
for the purposes of the Federal Tort
Claims Act (FTCA), employees and
certain qualified health care practitioner
contractors acting within the scope of
their employment with an entity
covered under the FSHCAA are deemed
to be employees of the Public Health
Service. 42 U.S.C. 233(g)(1)(A). As such,
these employees or qualified contractors
are deemed to be employees solely for
the purpose of securing coverage under
the FTCA in medical malpractice cases
brought against them. The current
definition of ‘‘employee’’ in the
Department’s regulations includes
employees and contractors of a covered
entity when the requested testimony
relates to their performance of medical,
surgical, dental or related functions
which were performed at a time when
HHS deemed the entity to be covered by
the FSHCAA, even in matters that do
not relate to medical malpractice
litigation.
The interests of the United States are
implicated in state court actions that
may impact upon liability under the
FTCA. By amending the definition to
require application of these regulations
in medical malpractice cases only, the
number of requests to the Department
for testimony of federally supported
health center employees and qualified
contractors will be significantly
reduced. Thus, the burden on the
Department to respond to these timeconsuming requests will be lessened.
Further, the current definition of
‘‘employee’’ under subpart (3) of section
2.2 refers to ‘‘the requested testimony or
information.’’ Because FSHCAA entities
and records are normally subject to state
law and are beyond the control of the
Department, we have only applied the
Department’s regulations in matters
involving the FSHCAA to requests for
testimony in FTCA matters, not to
record requests. Therefore, we have
limited this subpart to requests for
testimony.
Public Participation: This rule is
published as a final rule. It is exempt
from public comment, pursuant to 5
U.S.C. 553(b)(A), as a rule of ‘‘agency
organization, procedure, or practice.’’
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Paperwork Reduction Act: This
regulation is not subject to the
Paperwork Reduction Act because it
deals solely with the Department’s
internal rules of organization, procedure
or practice.
Cost/Regulatory Analysis: We have
examined the impact of this rule as
required by Executive Order (EO) 12866
(Regulatory Planning and Review), as
amended, the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.); the
Unfunded Mandated Reform Act of
1995 (UMRA) (2 U.S.C. 1501 et seq.);
and EO 13132 (Federalism). EO 12866,
as amended, directs agencies to assess
all costs and benefits of available
regulatory alternatives and, if regulation
is necessary, to select regulatory
approaches that maximize the benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). A regulatory impact analysis
must be prepared for major rules with
economically significant effects ($100
million or more in 1 year). We have
determined that the rule is consistent
with the principals set forth in the EO,
and we find that the rule would not
have an effect on the economy that
exceeds $100 million in any one year.
Under the RFA, if a rule has a
significant impact on a substantial
number of small entities, an agency
must analyze regulatory options that
would minimize any significant impact
of the rule on small entities and
determine it will not have any effect.
The agency has considered the effect
that this rule would have on small
entities. I hereby certify, under 5 U.S.C.
605(b), that the rule will not have a
significant economic impact on a
substantial number of small entities,
including small businesses, small
organizations and small local
governments. Therefore, a regulatory
flexibility analysis is not required. The
UMRA also requires that agencies assess
anticipated costs and benefits before
issuing any rule that may result in
expenditure in any one year by State,
local, or tribunal governments, in the
aggregate, or by the private sector of
$100 million. As noted above, we find
that the rule would not have an effect
of this magnitude on the economy.
Therefore, no further analysis is
required under the UMRA. EO 13132
establishes certain requirements that an
agency must meet when it promulgates
a final rule that imposes substantial
direct requirement costs on State and
local governments, preempts State law,
or otherwise has federalism
implications. We have reviewed the rule
under the threshold criteria of EO 13132
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and have determined that this rule
would not have substantial direct
impact on States, or on the distribution
of power and responsibilities among the
various levels of government. As there
are no federalism implications, a
federalism impact statement is not
required.
List of Subjects in 45 CFR Part 2
Administrative practice and
procedure, Freedom of Information,
Government employees.
■ Accordingly, for the reasons set forth
in the preamble, 45 CFR part 2 is
amended as follows:
PART 2—[AMENDED]
1. The authority citation for part 2
continues to read as follows:
■
Authority: 5 U.S.C. 301, 5 U.S.C. 552.
2. The definition of ‘‘Employee’’ in 45
CFR 2.2 is amended by revising the
introductory text and paragraphs (2) and
(3), adding paragraph (4), and placing
the definition in alphabetical order to
read as follows:
■
§ 2.2
Definitions.
*
*
*
*
*
Employee of the Department includes
current and former:
*
*
*
*
*
(2) Employees of intermediaries,
carriers, Medicare Administrative
Contractors, Program Safeguard
Contractors, and Recovery Audit
Contractors, and any successor entities,
that perform one or more of the
following functions described in section
1874A or 1893 of the Social Security
Act relating to the administration of the
Medicare program:
(i) Determination of payment
amounts; making payments; beneficiary
education and assistance; providing
consultative services; communication
with providers; or, provider education
and technical assistance; or,
(ii) Other such functions as are
necessary to carry out the Medicare
program, including any of the following
program integrity functions under
section 1893 of the Social Security Act:
(A) Review of activities of providers
or suppliers, including medical and
utilization review and fraud review;
(B) Auditing of cost reports;
(C) Determinations as to whether
payment should not be, or should not
have been, made because Medicare is
the secondary payer, and recovery of
payments that should not have been
made;
(D) Education of providers,
beneficiaries, and other persons with
respect to payment integrity and benefit
quality assurance issues; or,
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(E) Developing (and periodically
updating) a list of items of durable
medical equipment which are subject to
prior authorization.
(3) Employees of a contractor,
subcontractor, or state agency
performing survey, certification, or
enforcement functions under title XVIII
of the Social Security Act or Section 353
of the Public Health Service Act but
only to the extent the requested
information was acquired in the course
of performing those functions and
regardless of whether documents are
also relevant to the state’s activities.
(4) Employees and qualified
contractors of an entity covered under
the Federally Supported Health Centers
Assistance Act of 1992, as amended, 42
U.S.C. 233(g)–(n), (FSHCAA), provided
that the testimony is requested in
medical malpractice tort litigation and
relates to the performance of medical,
surgical, dental or related functions
which were performed by the entity, its
employees and qualified contractors at a
time when the DHHS deemed the entity
and its employees and qualified
contractors to be covered by the
FSHCAA.
*
*
*
*
*
Dated: August 28, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E8–21113 Filed 9–12–08; 8:45 am]
BILLING CODE 4150–26–P
20301–3062. Telephone 703–602–0311;
facsimile 703–602–7887.
SUPPLEMENTARY INFORMATION: This final
rule amends DFARS text as follows:
• 202.101. Adds the U.S.
Transportation Command to the list of
DoD contracting activities.
• 252.212–7001. Amends the
reference to the clause at 252.219–7004
in paragraph (b)(3) to reflect the current
clause date.
List of Subjects in 48 CFR Parts 202 and
252
Government procurement.
Michele P. Peterson,
Editor, Defense Acquisition Regulations
System.
Therefore, 48 CFR parts 202 and 252
are amended as follows:
■ 1. The authority citation for 48 CFR
parts 202 and 252 continues to read as
follows:
■
Authority: 41 U.S.C. 421 and 48 CFR
Chapter 1.
PART 202—DEFINITIONS OF WORDS
AND TERMS
202.101
[Amended]
2. Section 202.101 is amended in the
definition of ‘‘Contracting activity’’ by
adding at the end ‘‘United States
Transportation Command, Directorate of
Acquisition’’.
■
PART 252—SOLICITATION
PROVISIONS AND CONTRACT
CLAUSES
DEPARTMENT OF DEFENSE
252.212–7001
Defense Acquisition Regulations
System
[Amended]
3. Section 252.212–7001 is amended
as follows:
■ a. By revising the clause date to read
‘‘(SEP 2008)’’; and
■ b. In paragraph (b)(3) by removing
‘‘(APR 2007)’’ and adding in its place
‘‘(AUG 2008)’’.
■
48 CFR Parts 202 and 252
Defense Federal Acquisition
Regulation Supplement; Technical
Amendments
[FR Doc. E8–21375 Filed 9–12–08; 8:45 am]
Defense Acquisition
Regulations System, Department of
Defense (DoD).
ACTION: Final rule.
BILLING CODE 5001–08–P
SUMMARY: DoD is making technical
amendments to the Defense Federal
Acquisition Regulation Supplement
(DFARS) to update the list of DoD
contracting activities and to correct a
reference in a contract clause.
DATES: Effective Date: September 15,
2008.
Defense Acquisition Regulations
System
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AGENCY:
DEPARTMENT OF DEFENSE
48 CFR Parts 206, 225, and 252
RIN 0750–AG02
Ms.
Michele Peterson, Defense Acquisition
Regulations System, OUSD (AT&L)
DPAP (DARS), IMD 3D139, 3062
Defense Pentagon, Washington, DC
FOR FURTHER INFORMATION CONTACT:
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Defense Federal Acquisition
Regulation Supplement; Acquisitions
in Support of Operations in Iraq or
Afghanistan (DFARS Case 2008–D002)
Defense Acquisition
Regulations System, Department of
Defense (DoD).
AGENCY:
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53151
Interim rule with request for
comments.
ACTION:
SUMMARY: DoD has issued an interim
rule amending the Defense Federal
Acquisition Regulation Supplement
(DFARS) to implement Sections 886 and
892 of the National Defense
Authorization Act for Fiscal Year 2008.
Section 886 provides authority for DoD
to limit competition when acquiring
products or services in support of
operations in Iraq or Afghanistan.
Section 892 addresses competition
requirements for the procurement of
small arms for assistance to Iraq or
Afghanistan.
DATES: Effective date: September 15,
2008.
Comment date: Comments on the
interim rule should be submitted in
writing to the address shown below on
or before November 14, 2008, to be
considered in the formation of the final
rule.
ADDRESSES: You may submit comments,
identified by DFARS Case 2008–D002,
using any of the following methods:
Æ Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Æ E-mail: dfars@osd.mil. Include
DFARS Case 2008–D002 in the subject
line of the message.
Æ Fax: 703–602–7887.
Æ Mail: Defense Acquisition
Regulations System, Attn: Ms. Amy
Williams, OUSD (AT&L) DPAP (DARS),
IMD 3D139, 3062 Defense Pentagon,
Washington, DC 20301–3062.
Æ Hand Delivery/Courier: Defense
Acquisition Regulations System, Crystal
Square 4, Suite 200A, 241 18th Street,
Arlington, VA 22202–3402.
Comments received generally will be
posted without change to https://
www.regulations.gov, including any
personal information provided.
FOR FURTHER INFORMATION CONTACT: Ms.
Amy Williams, 703–602–0328.
SUPPLEMENTARY INFORMATION:
A. Background
Section 886 of the National Defense
Authorization Act for Fiscal Year 2008
(Pub. L. 110–181) provides authority for
DoD to limit competition when
acquiring products or services in
support of military operations or
stability operations in Iraq or
Afghanistan (including security,
transition, reconstruction, and
humanitarian relief activities) under
certain circumstances. In those
circumstances, and when the required
determination is made, Section 886
authorizes DoD to—
Æ Limit competition to products or
services from Iraq or Afghanistan;
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Agencies
[Federal Register Volume 73, Number 179 (Monday, September 15, 2008)]
[Rules and Regulations]
[Pages 53148-53151]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21113]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Part 2
Testimony by Employees and the Production of Documents in
Proceedings Where the United States Is Not a Party
AGENCY: Department of Health and Human Services.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rule amends Part 2 of Title 45 of the Code of Federal
Regulations, which provides that employees and former employees of the
Department of Health and Human Services (HHS or Department) may not
provide testimony as part of their official duties in litigation where
the United States or a federal agency is not a party, without the
approval of the head of the agency. The purpose of these amendments is
to modify the definition of ``employee'' contained in 45 CFR part 2.
Under these amendments, the definition of employee will be revised to
reflect changes in Medicare contracting, including changes brought
about by the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (MMA) (Pub. L. 108-173). In addition, the definition of
employee will be modified to include employees of a state agency
performing survey, certification, or enforcement functions under Title
XVIII of the Social Security Act or Section 353 of the Public Health
Service Act. Further, the definition of employee with respect to
employees of entities covered by the
[[Page 53149]]
Federally Supported Health Centers Assistance Act, as amended, 42
U.S.C. 233(g)-(n) (FSHCAA), will be limited to testimony requested in
medical malpractice tort litigation which relates to medical functions
performed at a time when the center was covered under FSHCAA.
DATES: Effective Date: October 15, 2008.
FOR FURTHER INFORMATION CONTACT: Jeffrey S. Davis, Associate General
Counsel, General Law Division, Office of the General Counsel,
Department of Health and Human Services, 330 Independence Ave., SW.,
Room 4760 Cohen Bldg., Washington, DC 20201, Telephone Number 202-619-
0150.
SUPPLEMENTARY INFORMATION: In 1987, the Department of Health and Human
Services published regulations addressing the issue of the increasing
number of requests for the testimony of Department employees in
litigation involving only private parties and not the United States.
The regulations generally prohibit an employee or former employee of
the Department from giving testimony concerning information acquired in
the course of performing official duties or because of such person's
official capacity, except where the relevant agency head determines
that the appearance would promote the objectives of the Department.
These amendments are designed to address changes in Medicare
contracting, including changes brought about by the MMA. The amendments
also address involvement of the Department in matters in which parties
request testimony or documents from employees of state survey agencies
or contractors that carry out survey, certification, or enforcement
activities for the Medicare and CLIA programs. Finally, these
amendments address the involvement of the Department in cases other
than medical malpractice matters where parties request testimony from
any current or former employee or contractor of an entity covered by
the FSHCAA.
Section 911 of the MMA added section 1874A to the Social Security
Act (SSA) and took the separate authorities under which the Centers for
Medicare & Medicaid Services (CMS) contracted with intermediaries and
carriers and consolidated them into a single authority for a new type
of contractor, the Medicare Administrative Contractor (MAC). See MMA
section 911. Under section 911, the Secretary may enter into contracts
with any eligible entity to serve as a MAC with respect to the
performance of the core Medicare administrative functions listed at SSA
section 1874A(a)(4). Thus, in the contracting environment created by
the MMA, MACs perform functions once performed solely by intermediaries
and carriers. Currently, CMS has agreements with intermediaries,
carriers and MACs to make Medicare payments for health care items and
services. Furthermore, under section 911(e) of the MMA, any reference
to a carrier or intermediary under title XI or XVIII of the Social
Security Act (or any regulation, manual instruction, interpretative
rule, statement of policy, or guideline issued to carry out these
titles) shall be deemed a reference to a MAC.
Furthermore, historically, carriers and intermediaries also carried
out all Medicare program integrity activities, such as cost report
audits and medical, utilization, and fraud reviews. However, CMS has
begun contracting with Program Safeguard Contractors (PSCs) and
Recovery Audit Contractors (RACs) to perform program integrity
activities, see SSA section 1893, although intermediaries and carriers
continue to carry out many program integrity functions. There is
substantial functional overlap between the functions that are performed
by PSCs and RACs and the program integrity activities that are now, or
were once, carried out by carriers and intermediaries.
Accordingly, we are amending the definition of ``employee'' in
these regulations to include the employees of contractors that perform
the core Medicare administrative functions listed at SSA sections
1874A(a)(4) and 1893. Under such definition, these regulations cover
intermediaries, carriers, MACs, PSCs and RACs, and any successor
entities that perform the functions listed in the amended definition.
Not only does this definition reflect the more flexible contracting
procedures created by the MMA, but a functional definition of
``employee'' also limits the need to amend these regulations again in
the event Congress further modifies the Medicare contracting
nomenclature through future legislation.
The second amendment concerns requests for testimony and documents
of employees of contractors, subcontractors, and state survey agencies
that carry out many of the Department's survey, certification, and
enforcement activities. Section 1864 of the Social Security Act
provides that the Secretary shall enter into agreements with states
under which appropriate state or local survey agencies determine
whether providers meet Medicare conditions of participation, suppliers
meet Medicare conditions of coverage, and rural health clinics meet
Medicare conditions of certification. Furthermore, under section 353(o)
of the Public Health Service Act, the Secretary is permitted to use the
services of state agencies to carry out his responsibilities under the
Clinical Laboratory Improvement Act Amendments of 1988 (CLIA). Thus,
employees of state survey agencies carry out federal functions for both
the Medicare and CLIA programs. In addition, contractors of the
Department under certain circumstances survey and certify providers and
suppliers. Contractors of the Department also perform validation
surveys to ensure that state survey agencies and deeming authorities
satisfactorily perform their survey, certification, and enforcement
responsibilities.
Parties in private litigation frequently request testimony and
documents from employees of contractors, subcontractors, and state
survey agencies that perform survey, certification, and enforcement
functions under the Medicare and CLIA programs. These requests are
especially prevalent in medical malpractice litigation. Although any
specific request for testimony or documents may not be unduly
burdensome, the requests divert employees from their federal survey,
certification, and enforcement responsibilities. The cumulative effect
of these requests can impede these activities. Moreover, we believe
that information gathered during these federal activities is federal
information and may be protected by governmental privileges. Therefore,
we are amending the definition of ``employee'' in these regulations to
include employees of contractors, subcontractors, and state survey
agencies that perform survey, certification, or enforcement activities
under the Medicare and CLIA programs.
We recognize that employees of state survey agencies may have dual
roles. These employees perform activities for the Medicare and CLIA
programs, but also have survey, certification, and enforcement
responsibilities with respect to state requirements. For example, it is
our understanding that state survey agencies commonly survey skilled
nursing facilities for compliance with both federal and state
requirements during a single visit. Under 45 CFR 2.1(a), the
Department's regulations apply only to information acquired in the
course of performing official duties or because of the employee's
official capacity with the Department. Therefore, these regulations
will apply to requests for testimony or documents from an employee of a
contractor, subcontractor, or state agency only to the extent the
information was acquired in the course of performing survey,
[[Page 53150]]
certification, or enforcement functions under Title XVIII of the Social
Security Act or section 353 of the Public Health Service Act and
regardless of whether documents are also relevant to the state's
activities.
The third amendment addresses the increasing frequency of requests
to the Department in cases other than medical malpractice matters for
employees and qualified contractors of entities covered under the
FSHCAA to provide testimony. The FSHCAA provides that, for the purposes
of the Federal Tort Claims Act (FTCA), employees and certain qualified
health care practitioner contractors acting within the scope of their
employment with an entity covered under the FSHCAA are deemed to be
employees of the Public Health Service. 42 U.S.C. 233(g)(1)(A). As
such, these employees or qualified contractors are deemed to be
employees solely for the purpose of securing coverage under the FTCA in
medical malpractice cases brought against them. The current definition
of ``employee'' in the Department's regulations includes employees and
contractors of a covered entity when the requested testimony relates to
their performance of medical, surgical, dental or related functions
which were performed at a time when HHS deemed the entity to be covered
by the FSHCAA, even in matters that do not relate to medical
malpractice litigation.
The interests of the United States are implicated in state court
actions that may impact upon liability under the FTCA. By amending the
definition to require application of these regulations in medical
malpractice cases only, the number of requests to the Department for
testimony of federally supported health center employees and qualified
contractors will be significantly reduced. Thus, the burden on the
Department to respond to these time-consuming requests will be
lessened.
Further, the current definition of ``employee'' under subpart (3)
of section 2.2 refers to ``the requested testimony or information.''
Because FSHCAA entities and records are normally subject to state law
and are beyond the control of the Department, we have only applied the
Department's regulations in matters involving the FSHCAA to requests
for testimony in FTCA matters, not to record requests. Therefore, we
have limited this subpart to requests for testimony.
Public Participation: This rule is published as a final rule. It is
exempt from public comment, pursuant to 5 U.S.C. 553(b)(A), as a rule
of ``agency organization, procedure, or practice.''
Paperwork Reduction Act: This regulation is not subject to the
Paperwork Reduction Act because it deals solely with the Department's
internal rules of organization, procedure or practice.
Cost/Regulatory Analysis: We have examined the impact of this rule
as required by Executive Order (EO) 12866 (Regulatory Planning and
Review), as amended, the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.); the Unfunded Mandated Reform Act of 1995 (UMRA) (2 U.S.C.
1501 et seq.); and EO 13132 (Federalism). EO 12866, as amended, directs
agencies to assess all costs and benefits of available regulatory
alternatives and, if regulation is necessary, to select regulatory
approaches that maximize the benefits (including potential economic,
environmental, public health and safety effects, distributive impacts,
and equity). A regulatory impact analysis must be prepared for major
rules with economically significant effects ($100 million or more in 1
year). We have determined that the rule is consistent with the
principals set forth in the EO, and we find that the rule would not
have an effect on the economy that exceeds $100 million in any one
year. Under the RFA, if a rule has a significant impact on a
substantial number of small entities, an agency must analyze regulatory
options that would minimize any significant impact of the rule on small
entities and determine it will not have any effect. The agency has
considered the effect that this rule would have on small entities. I
hereby certify, under 5 U.S.C. 605(b), that the rule will not have a
significant economic impact on a substantial number of small entities,
including small businesses, small organizations and small local
governments. Therefore, a regulatory flexibility analysis is not
required. The UMRA also requires that agencies assess anticipated costs
and benefits before issuing any rule that may result in expenditure in
any one year by State, local, or tribunal governments, in the
aggregate, or by the private sector of $100 million. As noted above, we
find that the rule would not have an effect of this magnitude on the
economy. Therefore, no further analysis is required under the UMRA. EO
13132 establishes certain requirements that an agency must meet when it
promulgates a final rule that imposes substantial direct requirement
costs on State and local governments, preempts State law, or otherwise
has federalism implications. We have reviewed the rule under the
threshold criteria of EO 13132 and have determined that this rule would
not have substantial direct impact on States, or on the distribution of
power and responsibilities among the various levels of government. As
there are no federalism implications, a federalism impact statement is
not required.
List of Subjects in 45 CFR Part 2
Administrative practice and procedure, Freedom of Information,
Government employees.
0
Accordingly, for the reasons set forth in the preamble, 45 CFR part 2
is amended as follows:
PART 2--[AMENDED]
0
1. The authority citation for part 2 continues to read as follows:
Authority: 5 U.S.C. 301, 5 U.S.C. 552.
0
2. The definition of ``Employee'' in 45 CFR 2.2 is amended by revising
the introductory text and paragraphs (2) and (3), adding paragraph (4),
and placing the definition in alphabetical order to read as follows:
Sec. 2.2 Definitions.
* * * * *
Employee of the Department includes current and former:
* * * * *
(2) Employees of intermediaries, carriers, Medicare Administrative
Contractors, Program Safeguard Contractors, and Recovery Audit
Contractors, and any successor entities, that perform one or more of
the following functions described in section 1874A or 1893 of the
Social Security Act relating to the administration of the Medicare
program:
(i) Determination of payment amounts; making payments; beneficiary
education and assistance; providing consultative services;
communication with providers; or, provider education and technical
assistance; or,
(ii) Other such functions as are necessary to carry out the
Medicare program, including any of the following program integrity
functions under section 1893 of the Social Security Act:
(A) Review of activities of providers or suppliers, including
medical and utilization review and fraud review;
(B) Auditing of cost reports;
(C) Determinations as to whether payment should not be, or should
not have been, made because Medicare is the secondary payer, and
recovery of payments that should not have been made;
(D) Education of providers, beneficiaries, and other persons with
respect to payment integrity and benefit quality assurance issues; or,
[[Page 53151]]
(E) Developing (and periodically updating) a list of items of
durable medical equipment which are subject to prior authorization.
(3) Employees of a contractor, subcontractor, or state agency
performing survey, certification, or enforcement functions under title
XVIII of the Social Security Act or Section 353 of the Public Health
Service Act but only to the extent the requested information was
acquired in the course of performing those functions and regardless of
whether documents are also relevant to the state's activities.
(4) Employees and qualified contractors of an entity covered under
the Federally Supported Health Centers Assistance Act of 1992, as
amended, 42 U.S.C. 233(g)-(n), (FSHCAA), provided that the testimony is
requested in medical malpractice tort litigation and relates to the
performance of medical, surgical, dental or related functions which
were performed by the entity, its employees and qualified contractors
at a time when the DHHS deemed the entity and its employees and
qualified contractors to be covered by the FSHCAA.
* * * * *
Dated: August 28, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E8-21113 Filed 9-12-08; 8:45 am]
BILLING CODE 4150-26-P