With increased government scrutiny on telehealth and potential changes to COVID-era telehealth flexibilities on the horizon, it is critical that companies utilizing telehealth strategies consider compliance measures to mitigate potential regulatory risk. Below are some steps companies may take.

Survey current policies and modify accordingly. As the legal landscape on telehealth evolves, companies can protect themselves by staying abreast of new developments and adjusting their own policies to comply. For example, companies may create a taskforce to evaluate current policies and work with legal counsel to determine potential gaps that make the company susceptible to risk. Companies can develop tailored telehealth policies that establish guardrails relating to the physician-patient relationship, electronic prescribing and in-person follow-up.

Proactively plan for new rulemaking regarding virtual prescriptions. With COVID-era flexibilities on virtual prescriptions set to expire at the end of 2024, companies may consider creating a plan for how to handle their prescription policies so they adhere to any and all updated regulatory requirements, at both the federal and state levels. Companies can proactively establish policies that mandate in-person appointments under certain circumstances, in compliance with the new rules. It is also crucial that companies plan in advance for any situations that will require in-person appointments so patient care is not interrupted.

Encourage employees to report legal concerns. It is important that telehealth companies encourage employees to report potential legal violations because many federal and state investigations are the result of whistleblowers who felt unheard within the company and feel the need to voice their concerns about their company's practices. In addition to creating anonymous reporting methods, telehealth companies can create a non-retaliation policy to ensure that employees feel comfortable reporting any suspicious conduct. The company can take internal complaints seriously by following up on them in a substantive manner.

Be cognizant of the Anti-Kickback Statute and Safe Harbor Regulations. In developing policies to mitigate risk, it is useful for companies to be aware of the Anti-Kickback Statute and how it may affect telehealth arrangements. The Anti-Kickback Statute prohibits offering or receiving payment to induce referrals of federal health care program business. For example, one area for telehealth companies to avoid is compensating a practitioner "based on the volume of items or services ordered or prescribed;" instead, they may consider arranging compensation through one-year consulting agreements. Similarly, companies should be aware that providing real estate or office space to providers at less than the market rate can increase kickback risk. Notably, there are various Safe Harbor Regulations, which describe arrangements that would be shielded from prosecution under the Anti-Kickback Statute; understanding these exceptions can help companies in assessing risk.

Telehealth is an exciting industry that has made health care more accessible to many patients, but certain bad actors have raised alarm bells, subjecting the practice to increased government scrutiny and regulation. The future of telehealth as we've known it may be uncertain, but it is important for legitimate telehealth companies to understand the current environment and where others went wrong, and prepare to adapt to new rulemaking to help mitigate the risk of potential litigation or investigation.

Instant Insights /

Telehealth is here to stay: Steps companies can take to maintain compliance

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