Healthcare Regulatory Compliance
Federal and state fraud and abuse analysis, HIPAA compliance, and regulatory guidance for telehealth companies and healthcare business arrangements.
Federal Fraud & Abuse Statutes
Telehealth companies and healthcare businesses must evaluate their operations against federal fraud and abuse statutes that govern referral relationships, compensation arrangements, and business structures involving federal healthcare program beneficiaries.
Anti-Kickback Statute (AKS)
The federal Anti-Kickback Statute prohibits offering, paying, soliciting, or receiving anything of value to induce or reward referrals for services covered by federal healthcare programs. Violations can result in criminal penalties, civil monetary penalties, and exclusion from federal programs. Telehealth business arrangements — including marketing agreements, referral arrangements, and compensation structures — must be analyzed for AKS compliance and potential safe harbor applicability.
Stark Law (Physician Self-Referral Law)
The Stark Law prohibits physicians from referring patients to entities with which the physician (or an immediate family member) has a financial relationship for designated health services payable by Medicare or Medicaid, unless an exception applies. Telehealth companies that involve physician referrals for covered services must evaluate Stark Law applicability and structure arrangements within available exceptions.
Civil Monetary Penalties Law (CMPL)
The Civil Monetary Penalties Law provides for penalties against individuals or entities that offer remuneration to Medicare or Medicaid beneficiaries to influence their selection of a provider. This statute is particularly relevant for telehealth companies offering incentives, discounts, or free services to patients covered by federal healthcare programs.
False Claims Act (FCA)
The False Claims Act imposes liability on persons and companies who submit, or cause the submission of, false or fraudulent claims to government healthcare programs. Telehealth companies must ensure that their billing practices, coding, and documentation comply with applicable requirements to mitigate False Claims Act exposure.
Additional Regulatory Areas
Beyond federal fraud and abuse statutes, telehealth companies face a range of regulatory requirements at both the federal and state level.
HIPAA privacy and security compliance for telehealth platforms
State consumer protection and unfair business practices considerations
State-specific anti-kickback and self-referral statutes
FDA regulation of digital health technologies and software as a medical device
Pharmacy regulation and compounding compliance
Laboratory services arrangements and CLIA considerations
Payor and billing compliance for telehealth services
Compliance program development and risk assessment
Note: The information on this page is for general informational purposes only and does not constitute legal advice. Regulatory compliance requires fact-specific analysis. Contact Telehealth.law to discuss your regulatory compliance needs.
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