On October 9, 2019, the Centers for Medicare and Medicare Services (CMS) released proposed changes to the regulations interpreting the Physician Self-Referral Law (Stark Law), including a new proposed exception for limited remuneration to a physician.
CMS desires to create an exception to offer protection for certain non-abusive arrangements that cannot satisfy existing Stark Law exceptions due to reasons including the dollar limit, documentation, signature and/or the “set in advance” requirement in current existing exceptions.
The following conditions must be satisfied to receive protection under the proposed new exception:
Arrangements that satisfy these conditions are, in CMS’ view, unlikely to cause overutilization or similar harms to the Medicare program, even in the absence of documentation regarding the arrangement and when the amount of or formula for calculating the remuneration is not set in advance of the provision of items or services.
Noteworthy aspects of the new proposed limited remuneration exception include:
While CMS views the $3,500 annual limit as sufficient to cover the typical range of commercially reasonable arrangements for the provision of items and services that a physician might provide to an entity on an infrequent or short-term basis, it is still seeking public comment on whether that amount is too high or too low.
Public comments on the proposed changes to the regulations interpreting the Stark Law are due December 31, 2019. As a result, the CMS will not finalize the proposed changes until 2020.
This publication is part of a series of updates regarding CMS and OIG's proposed fraud and abuse law changes. Bricker & Eckler's health care attorneys will continue to publish analyses of the proposed rules.