Compliance Statement | TheraVite Health

Notice: This document contains template language modeled on industry-standard healthcare disclosures. Before TheraVite Health relies on this language for legal or regulatory compliance — and before this site collects any patient health information — qualified healthcare counsel must review and finalize each policy. Patients and providers should not rely on this document until that review is complete.

Our compliance program

TheraVite Health, Inc. maintains a comprehensive compliance program designed to prevent, detect, and respond to violations of law, regulations, and TheraVite’s policies. The program is structured around the seven elements of an effective compliance program identified by the U.S. Department of Health and Human Services Office of Inspector General (OIG):

Written standards — written policies, procedures, and a Code of Conduct that articulate the organization’s commitment to compliance
Compliance leadership — designation of a Compliance Officer and Compliance Committee with authority to oversee compliance activities
Training and education — regular compliance training for all employees, contractors, and agents
Effective lines of communication — multiple channels for reporting compliance concerns, including an anonymous mechanism
Auditing and monitoring — internal auditing and monitoring activities to detect compliance issues
Enforcement and discipline — well-publicized disciplinary guidelines applied consistently
Response and prevention — prompt response to detected violations, including corrective action and prevention of recurrence

Areas of compliance focus

HIPAA Privacy and Security Rule compliance
Federal Anti-Kickback Statute and Stark Law compliance
False Claims Act compliance
Medicare and Medicaid billing accuracy
Drug Supply Chain Security Act (DSCSA) compliance
FDA regulations applicable to specialty pharmacy operations
State pharmacy licensure and practice standards
USP General Chapter <797> standards for sterile compounding
USP General Chapter <800> standards for hazardous drug handling
OSHA and occupational safety standards

Reporting compliance concerns

Anyone — patients, providers, employees, contractors, vendors, or members of the public — may report a suspected compliance concern. Reports may be submitted to:

TheraVite Health, Inc.
Attn: Compliance Officer
Danbury, CT
Email: info@theravitehealth.com

Non-retaliation

TheraVite prohibits retaliation against any individual who, in good faith, reports a compliance concern, participates in an investigation, or refuses to engage in a practice the individual reasonably believes to be unlawful or unethical.

Cooperation with investigations

TheraVite cooperates fully with investigations by federal, state, and local regulatory and enforcement agencies, including the OIG, CMS, FDA, DEA, the Department of Justice, state attorneys general, state pharmacy boards, and accreditation bodies.