There are several Federal fraud and abuse laws that apply to health care professionals. Two of those have the greatest potential implications for telehealth and include the Anti-Kickback Statute and Stark Law.
- Anti-Kickback Statute: This law prohibits the knowing and willful payment of "remuneration" to induce or reward patient referrals or the generation of business involving any item or service payable by Federal health care programs (e.g., Medicare). This practice is often known as "paying for referrals". For telehealth, this could mean "giving away:" software licenses, telehealth equipment, peripheral devices and more.
- Physician Self-Referral Law (Stark Law): This law prohibits physicians from referring patients to receive "designated health services" payable by Medicare ore Medicaid from entities with which the physician or immediate family member has a financial relationship, unless an exception applies.
With that said, it would be useful to read these two article by the Center for Connected Health Policy for a better context and understanding when it comes to fraud and telehealth:
- Fraud is Fraud: So, Don't Blame Telehealth
- Telefraud vs. Telehealth...is it really telemedicine fraud?
Resources:
- Office of Inspector General Special Fraud Alert: This special fraud alert asks practitioners to exercise caution when entering into arrangements with purported telemedicine companies.
- Office of Inspector General Consumer Alert: This consumer alert is about a fraud scheme involving monthly billing for remote patient monitoring for Medicare enrollees.
- Office of Inspector General Report: Additional Oversight of Remote Patient Monitoring in Medicare Is Needed: The use of remote patient monitoring in Medicare increased dramatically from 2019 to 2022 and has the potential to greatly expand. As a result, the OIG and CMS have raised concerns about fraud. This report examines how remote monitoring is being used, identifies vulnerabilities and makes recommendations for strengthening oversight.
- Comparison of the Anti-Kickback Statue and the Stark Law: This simple side by side comparison chart provides a good overview of each of these laws.
- Fact Sheet Clarifying the Physician Self-Referral Regulations Final Rule: On November 20, 2020, CMS issued a final rule to modernize and clarify the regulations that interpret the Stark Law. This fact sheet discussed the major provisions and links to the Federal Register notice.
- Key Takeaways from the Revised and Clarified Stark Law Regulations: Attorneys at Foley & Lardner created this two-part post to highlight key changes, clarifications and discussions.
- Self-Referral Disclosure Protocol: This is the Medicare self-referral disclosure protocol, enabling providers of services and suppliers to self-disclose actual or potential violations of the physician self-referral statute.