[Federal Register: September 15, 2008 (Volume 73, Number 179)]
[Rules and Regulations]
[Page 53148-53151]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15se08-16]
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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.
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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]
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