Healthcare Regulations: Is Your Organization Legally Protected?

HIPAA requires every covered provider to give patients a Notice of Privacy Practices at the first encounter, use and disclose patient information only to the minimum extent necessary, grant patients the right to access their records within thirty days, and sign Business Associate Agreements with any vendor handling patient data. The Security Rule requires a documented risk analysis, workforce training, controlled physical access to patient data systems, and technical safeguards including access logs, encryption, and automatic session timeout.

Data privacy and data breach litigation counsel can advise on the HIPAA Privacy and Security Rule requirements, assess whether PHI safeguards and breach response procedures meet the required standards, and develop the HIPAA compliance and breach notification strategy.

The False Claims Act imposes liability on any provider that knowingly submits a false claim to a federal health program, and courts have held that upcoding, billing for services not rendered, and billing for medically unnecessary services all qualify even without specific fraudulent intent. The Anti-Kickback Statute prohibits any payment offered to induce federal program referrals, and any compensation arrangement or lease with a referral source must fit within a published safe harbor before implementation.

Healthcare fraud and Medicare billing fraud counsel can advise on False Claims Act and Anti-Kickback Statute requirements for billing and referral practices, assess whether current arrangements satisfy available safe harbors, and develop the fraud and abuse compliance strategy.

Informed consent requires disclosure of the proposed procedure, its material risks and benefits, available alternatives, and consequences of declining, followed by the patient's voluntary agreement documented in the chart before the procedure begins. A provider whose chart does not reflect this discussion faces a significant disadvantage in any malpractice claim, because a jury assesses the adequacy of consent based on what is written in the record rather than on the provider's undocumented recollection.

Medical malpractice and healthcare and life sciences counsel can advise on the informed consent and documentation standards for the specific practice setting, assess whether current consent and recordkeeping practices satisfy the standard of care, and develop the malpractice risk management and documentation strategy.

The Stark Law prohibits a physician from referring Medicare or Medicaid patients to any entity providing designated health services where the physician or an immediate family member has a financial relationship, unless a specific statutory or regulatory exception is satisfied. Employment and personal services exceptions require that compensation be set in advance, consistent with fair market value, and not vary based on referral volume, and a provider that cannot satisfy every element faces mandatory repayment of all claims submitted during the non-compliant period.

Medicaid fraud and corporate compliance and risk management counsel can advise on the Stark Law self-referral restrictions and applicable exceptions, assess whether compensation and ownership arrangements satisfy the required criteria, and develop the Stark Law compliance and disclosure strategy.

Healthcare employers must comply with OSHA's bloodborne pathogens standard by maintaining a written exposure control plan, offering hepatitis B vaccination to all at-risk employees at no cost, providing personal protective equipment, and conducting annual training. Hospitals and larger facilities must also satisfy the Hazard Communication Standard by maintaining safety data sheets for all hazardous chemicals, labeling containers, and training employees on chemical hazards.

OSHA compliance and regulatory compliance counsel can advise on the OSHA standards applicable to the healthcare setting, assess whether workplace safety and infection control programs satisfy the required standards, and develop the OSHA compliance and inspection response strategy.

A healthcare compliance program following the OIG's seven-element framework should include written policies for each regulatory area, a compliance officer with board access, a confidential reporting mechanism, annual training, regular internal audits, a corrective action process, and a self-disclosure mechanism for violations identified before external discovery. A provider that voluntarily discloses a problem to the OIG is consistently treated more favorably than one that waits for an audit, whistleblower complaint, or government subpoena.

Risk management and management of risk counsel can advise on the design of a healthcare compliance program consistent with OIG guidance, assess whether existing policies, training, and audit procedures satisfy the seven-element framework, and develop the compliance program structure and self-disclosure strategy.