May 28, 2020  

A previous Cutting Edge Information blog post discussed that the Centers for Medicare & Medicaid Services (CMS) would provide flexibility for companies when reporting Open Payments data. More recently, the US Department of Health and Human Services (HHS) announced further action regarding HCP transfer of value regulations to help combat the situation associated with COVID-19.

First made public on March 13 and more recently amended on May 15, blanket waivers issued by the HHS provide exemptions for a number of HCP activities. Normally these exemptions would be enforced under the Stark Law to prevent fraud and abuse within the healthcare industry. But ongoing circumstances related to COVID-19 prompted the HHS to provide regulatory leniency to ensure that an adequate level of healthcare and medical supplies is available.

Unless the US government makes a clear determination of fraud or abuse, many HCP activities associated with the Stark Law would be given exemptions. A few real-world examples of activities that would receive exemptions include:

  • A hospital pays physicians above their previously contracted rates for providing professional services for COVID-19 patients in particularly hazardous or challenging environments.
  • An entity provides nonmonetary compensation to a physician or an immediate family member of a physician in excess of the $423 per year limit (per physician or immediate family member). Examples of nonmonetary compensation include continuing medical education related to the COVID-19 outbreak in the United States, supplies, food or other grocery items, isolation-related needs (for instance, hotel rooms and meals), child care or transportation.
  • A physician refers a Medicare beneficiary to a home health agency owned by the immediate family member of the physician because there are no other home health agencies with capacity to provide medically necessary home health services to the beneficiary during the COVID-19 pandemic in the United States.

A full list of examples, along with the actual activities as described by the HHS, can be found by clicking here. While certain payments under the Stark Law are exempt, payments made to HCPs should still follow FMV standards to avoid government scrutiny.

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ABOUT THE AUTHOR

Todd Middleton is a senior research analyst at Cutting Edge Information. In this position, he provides qualitative FMV information for in-house and external use to ensure compliant HCP engagements. As an analyst, Mr. Middleton affirms that accurate data, in combination with topical research, can ensure successful life science company compliance. He is a graduate of the College of Charleston.

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