CAUTIONARY STATEMENT FOR
PURPOSES OF THE “SAFE HARBOR” PROVISIONS OF THE PRIVATE SECURITIES LITIGATION
REFORM ACT OF 1995
Some statements and disclosures in this document
are forward-looking statements. Forward-looking statements include all statements that do not relate
solely to historical or current facts and can be identified by the use of words
such as “may”, “believe”, “will”, “expect”, “project”, “estimate”,
“anticipate”, “plan” or “continue”. These forward-looking statements are based on our current plans and
expectations and are subject to a number of risks and uncertainties that could
significantly cause our plans and expectations, including actual results, to
differ materially from the forward-looking statements. The Private Securities Litigation Reform Act
of 1995, or the Litigation Reform Act, provides a “safe harbor” for
forward-looking statements to encourage companies to provide prospective
information about their companies without
fear of litigation.
We would like to take advantage of the “safe
harbor” provisions of the Litigation Reform Act in connection with the
forward-looking statements included in this document. Investors are cautioned not to unduly rely on such
forward-looking statements when evaluating the information presented in this
document. The following important
factors could cause our actual financial results to differ materially from
those projected, forecasted or estimated by us in
forward-looking statements:
(a) Heightened
competition, including increased pricing pressure, competition from hospitals
for testing for non-patients and competition from physicians. See “Business—Competition”.
(b) Impact
of changes in payer mix, including any shift from fee-for-service to capitated
fee arrangements. See “Business—Payers and Customers—Customers—Managed
Care Organizations and Other Insurance Providers”.
(c) Adverse
actions by government or other third-party payers, including unilateral
reduction of fee schedules payable to us, competitive bidding, or an increase
in the practice of negotiating for exclusive contracts that involve
aggressively priced capitated payments by managed care organizations. See “Business—Regulation of Reimbursement
for Clinical Laboratory Services” and “Business—Payers and Customers—Customers—Managed Care Organizations and Other Insurance Providers”.
(d) The
impact upon our testing volume and collected revenue or general or
administrative expenses resulting from our compliance with Medicare and
Medicaid administrative policies and requirements of third party payers. These include:
(1)
the requirements of
Medicare carriers to provide diagnosis codes for many commonly ordered tests
and the possibility that third party payers will increasingly adopt similar
requirements;
(2)
the policy of CMS to
limit Medicare reimbursement for tests contained in automated chemistry panels
to the amount that would have been paid if only the covered tests, determined
on the basis of demonstrable “medical necessity”, had been ordered;
(3)
continued
inconsistent practices among the different local carriers administering Medicare;
(4)
inability
to obtain from patients an advance beneficiary notice form for tests that cannot
be billed without prior receipt of the form; and
(5)
the potential need to
monitor charges and lower certain fees to Medicare to comply with the OIG’s
proposed rule pertaining to exclusion of providers for submitting claims to
Medicare containing charges that are substantially in excess of the provider’s
usual charges.
See “Business—Regulation of Reimbursement for Clinical
Laboratory Services” and “Business—Billing”.
(e) Adverse
results from pending or future government investigations, lawsuits or private
actions. These include, in particular
significant monetary damages, loss or suspension of licenses, and/or suspension
or exclusion from the Medicare and Medicaid programs and/or other significant
litigation matters. See “Business—Government Investigations and Related Claims”.
(f)
Failure to obtain new
customers at profitable pricing or failure to retain existing customers, and a
reduction in tests ordered or specimens submitted by existing customers.
(g)
Failure to efficiently
integrate acquired clinical laboratory businesses, including Unilab, or to
efficiently integrate clinical laboratory businesses from joint ventures and
alliances with hospitals, and to manage the costs related to any such
integration, or to retain key technical and management personnel. See “Business—Recent Acquisitions”.
(h)
Inability to obtain
professional liability or other insurance coverage or a material increase in
premiums for such coverage or reserves for self-insurance. See “Business—Insurance”.
(i)
Denial
of CLIA certification or other licenses for any of our clinical laboratories
under the CLIA standards, revocation or suspension of the right to bill the Medicare
and Medicaid programs or other adverse regulatory actions by federal, state and
local agencies. See “Business—Regulation of Clinical Laboratory Operations”.
(j)
Changes
in federal, state or local laws or regulations, including changes that result
in new or increased federal or state regulation of commercial clinical laboratories,
including regulation by the FDA.
(k)
Inability
to achieve expected synergies from our acquisitions of other business, including
Unilab. See “Business—Recent Acquisitions”.
(l)
Inability
to achieve additional benefits from our Six Sigma and standardization initiatives.
(m)
Adverse
publicity and news coverage about the clinical laboratory industry or us.
(n)
Computer
or other system failures that affect our ability to perform tests, report test
results or properly bill customers, including potential failures resulting from
the standardization of our IT systems and other system conversions,
telecommunications failures, malicious human acts (such as electronic break-ins
or computer viruses) or natural disasters. See “Business—Information
Systems” and “Business - Billing”.
(o)
Development
of technologies that substantially alter the practice of laboratory medicine,
including technology changes that lead to the development of more
cost-effective tests such as (1) point-of-care tests that can be performed by
physicians in their offices and (2) home testing that can be carried out
without requiring the services of clinical laboratories. See “Business—Competition” and “Business—Regulation of Clinical Laboratory Operations”.
(p)
Issuance
of patents or other property rights to our competitors or others that could prevent,
limit or interfere with our ability to develop, perform or sell our tests or
operate our business.
(q)
Development
of tests by our competitors or others which we may not be able to license, or
usage of our technology or similar technologies or our trade secrets by competitors,
any of which could negatively affect our competitive position.
(r)
Inability
to commercialize newly licensed tests or technologies or to obtain appropriate
reimbursements for such tests.
(s)
Inability
to obtain or maintain adequate patent and other propriety rights protections
of our products and services or to successfully enforce our proprietary rights.
(t)
Development
of an Internet-based electronic commerce business model that does not require
an extensive logistics and laboratory network.
(u)
The
impact of the privacy regulations, security regulations and standards for electronic
transactions regulations issued under HIPAA on our operations as well as the
cost to comply with the regulations, including the failure of third party
payers to complete testing with us, failure to agree on data content for
claims, failure to accept default diagnosis codes in the absence of
physician-supplied codes, or inability of payers to accept or remit
transactions in HIPAA-required standard transaction and code set format. See “Business—Privacy
and Security of Health Information; Standard Transactions”.
(v)
Inability
to promptly or properly bill for our services or to obtain appropriate payments
for services that we do bill. See
“Business—Billing”.
(w)
Changes
in interest rates and changes in our credit ratings from Standard & Poor’s
and Moody’s
Investor Services causing an unfavorable impact on our cost of and access to
capital.
(x)
Inability
to hire and retain qualified personnel or the loss of the services of one or
more of our key senior management personnel.
(y)
Terrorist and other criminal activities, which could affect our
customers, transportation or power systems, or our facilities, and for which
insurance may not adequately reimburse us for. |