The Stark law, from inception to COVID-19 blanket waivers: a review

AbstractThe concept of physicians referring patients to their own healthcare entities is considered a “self-referral”. A discerning factor of a self-referral is when the physician has a financial interest in the entity of patient referral. Prospects of healthcare overutilization and costs, thereby, rise. Self-referral laws, therefore, are important to regulate overutilization and contain costs. In the 1980s, Congressman Fortney Stark initiated an act that was one of the precursors to one such self-referral law, known as the Stark Law. The Stark Law, in its initial phase, known as Stark I, addressed self-referrals selectively from laboratory services. Stark I, thereafter, in a series of subsequent amendments and enactments, burgeoned to include multiple services, referred as Designated Health Services (DHS), for self-referrals. The expanded law, inclusive of those DHS, is now known as Stark II. The passage of the 2010 Affordable Care Act as well as the prevailing 2019 Coronavirus Disease (COVID-19) pandemic further modified the Stark Law. Given the legislative history of the said law, the present review curates the legal initiatives of this law from its nascent formative stages to the present form. The purpose of the above curation is to present a bird’s eye view of its evolution and present analysts of any future research segments. This review, furthermore, describes the waivers of this law specific to COVID-19, or COVID-19 blanket waivers, which are instruments to assuage any barriers and further placate any hurdles arising from this law prevalent in this pandemic.