HCA Holdings 2011 Annual Report Download - page 50

• screening, stabilization and transfer of individuals who have emergency medical conditions;
• licensure and certification;
• hospital rate or budget review;
• preparing and filing of cost reports;
• operating policies and procedures;
• activities regarding competitors; and
• addition of facilities and services.
Among these laws are the federal Anti-kickback Statute, the federal Stark Law, the federal FCA and similar
state laws. We have a variety of financial relationships with physicians and others who either refer or influence
the referral of patients to our hospitals and other health care facilities, and these laws govern those relationships.
The OIG has enacted safe harbor regulations that outline practices deemed protected from prosecution under the
Anti-kickback Statute. While we endeavor to comply with the applicable safe harbors, certain of our current
arrangements, including joint ventures and financial relationships with physicians and other referral sources and
persons and entities to which we refer patients, do not qualify for safe harbor protection. Failure to qualify for a
safe harbor does not mean the arrangement necessarily violates the Anti-kickback Statute but may subject the
arrangement to greater scrutiny. However, we cannot offer assurance that practices outside of a safe harbor will
not be found to violate the Anti-kickback Statute. Allegations of violations of the Anti-kickback Statute may be
brought under the federal Civil Monetary Penalty Law, which requires a lower burden of proof than other fraud
and abuse laws, including the Anti-kickback Statute.
Our financial relationships with referring physicians and their immediate family members must comply with
the Stark Law by meeting an exception. We attempt to structure our relationships to meet an exception to the
Stark Law, but the regulations implementing the exceptions are detailed and complex, and we cannot provide
assurance that every relationship complies fully with the Stark Law. Unlike the Anti-kickback Statute, failure to
meet an exception under the Stark Law results in a violation of the Stark Law, even if such violation is technical
in nature.
Additionally, if we violate the Anti-kickback Statute or Stark Law, or if we improperly bill for our services,
we may be found to violate the FCA, either under a suit brought by the government or by a private person under
aqui tam, or “whistleblower,” suit. See Item 1, “Business — Regulation and Other Factors.”
If we fail to comply with the Anti-kickback Statute, the Stark Law, the FCA or other applicable laws and
regulations, we could be subjected to liabilities, including civil penalties (including the loss of our licenses to
operate one or more facilities), exclusion of one or more facilities from participation in the Medicare, Medicaid
and other federal and state health care programs and, for violations of certain laws and regulations, criminal
penalties.
We do not always have the benefit of significant regulatory or judicial interpretation of these laws and
regulations. In the future, different interpretations or enforcement of, or amendment to, these laws and
regulations could subject our current or past practices to allegations of impropriety or illegality or could require
us to make changes in our facilities, equipment, personnel, services, capital expenditure programs and operating
expenses. A determination that we have violated these laws, or the public announcement that we are being
investigated for possible violations of these laws, could have a material, adverse effect on our business, financial
condition, results of operations or prospects, and our business reputation could suffer significantly. In addition,
other legislation or regulations at the federal or state level may be adopted that adversely affect our business.
We have been and could become the subject of governmental investigations, claims and litigation.
Health care companies are subject to numerous investigations by various governmental agencies. Further,
under the FCA, private parties have the right to bring qui tam, or “whistleblower,” suits against companies that
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