Healthcare & FDA Law Blog

Physicians who wish to work in the medical tourism sector need to be careful to separate their medical tasks from their business and marketing tasks and to avoid fee-splitting issues

Ambulatory surgery centers are attractive to doctors and patients due to reduced wait times, better control over infections, and other reasons – provided the ASCs do not violate the AKS or Stark Law.

Many states are easing the restrictions on using telehealth during COVID including easing licensing requirements and in-person visit requirements.

Many states, such as Illinois, Iowa, Massachusetts, Minnesota, New Jersey, and North Carolina, are easing the restrictions on using telehealth serviced during the COVID pandemic.

Many states, such as Florida, Kansas, Kentucky, Michigan, and New York are easing the restrictions on using telehealth serviced during the COVID pandemic.

The Centers for Medicare & Medicaid (CMS) identified 18 waivers to Stark Law’s prohibition against self-referrals. The waivers are based on the form of remuneration and the type of financial relationship.

FDA is sending warning letters to companies that claim the company can diagnose COVID-19. FDA has granted an Emergency Use Authorization) for at least one at-home testing kit.

Violations of the AKS and Stark Law are usually violations of the False Claims Act. Penalties can include treble damages and exclusion from Medicaid and Medicare Payments

Most 2021 healthcare trends include new technology such as genome editing, mRNA messaging, artificial intelligence, predictive analytics, and advanced EHR systems.