At the end of 2020, the Centers for Medicare and Medicaid Services (CMS) issued updated guidance on the thresholds that require an Applicable Manufacturer or Group Purchasing Organization to report under the Sunshine Act.
Under the new guidance, if an Applicable Manufacturer or Group Purchasing Organization spends $11.05 or more on a “Reportable Activity” for any Covered Recipient from January 1, 2021 through December 31, 2021, the payment must be reported. This is up from $10.98 in 2020. Additionally, even if the amount spent on a “Reportable Activity” is $11.04 or less, it will need to be reported if the aggregate payments exceed $110.40 in the 2021 calendar year. If the aggregate sum exceeds $110.40 in 2021, all payments and other transfers of value made to the Covered Recipient must be reported.
Other Sunshine Act Reminders
Prior to this year, a Covered Recipient only included physicians (other than physicians that were a bona fide employee of the applicable manufacturer reporting the payment) and teaching hospitals (any institution that received a payment under Sections 1886(d)(5)(B), 1886(h), or 1886(s) of the Social Security Act during the last calendar year for which such information is available.
However, starting in 2021, the definition of Covered Recipient has expanded to include five new provider types: physician assistants; nurse practitioners; clinical nurse specialists; certified registered nurse anesthetists and anesthesiologist assistants; and certified nurse midwives.
Sunshine Act Refresher
As a reminder, Applicable Manufacturers and Group Purchasing Organizations must report both direct and indirect payments or other transfers of value provided to a Covered Recipient (Such as a lunch) as well as direct and indirect payments/other transfers of value given to a third party at the request of the Covered Recipient, or designated by the Applicable Manufacturer on behalf of a Covered Recipient.
Applicable Manufacturers and Group Purchasing Organizations must report their data from prior calendar years to CMS no later than March 31 annually. Failure to timely, accurately, or completely report the required information may result in Civil Monetary Penalties between $1,000 and $10,000 for each payment or other transfer of value or ownership investment interest not reported timely, accurately, or completely. The total Civil Monetary Penalties imposed on an Applicable Manufacturer or Group Purchasing Organization shall not exceed $150,000 annually. Knowing to timely, accurately, or completely report the required information has higher fines: between $10,000 and $100,000 for each payment or other transfer of value, not to exceed $1,150,000 annually.