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Shenoy et al. Patient Safety in Surgery

(2022) 16:19

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Table 2 List of Financial Exceptions under the Stark Law

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Owning stocks or bonds in a large, publicly traded company or mutual fund, Owning or investing in certain rural providers or hospitals in Puerto Rico,

Reasonable rent for office space or equipment,

eligible physicians during the ongoing national and pub lic health emergencies. Stark Law blanket waivers during the COVID‑19 pandemic Section 1135 of the Social Security Act authorizes the Secretary of the Department of Health and Human Ser vices to waive or modify certain requirements of health care programs such as Medicare, Medicaid, Children’s Health Insurance Program (CHIP), and Health Insurance Portability and Accountability Act (HIPAA) of 1996 [13]. There are two prerequisites that need to be met before the Secretary invokes the authority to waive or mod ify certain requirements of the above programs [13]. Those two prerequisites are: (1) the President must have declared an emergency or disaster under either the Staf ford Act or the National Emergencies Act [13], and (2) the Secretary must have declared a Public Health Emer gency under Sect. 319 of the Public Health Service Act [13]. On March 13, 2020, President Donald J. Trump pro claimed a nationwide emergency pursuant to Sec. 501(b) of the Stafford Act [14]. On January 31, 2020, prior to the above Presidential declaration, Alex M. Azar II, Sec retary of the Department of Health and Human Ser vices (DHHS), determined under Sect. 319 of the Public Health Service (PHS) Act, that a nationwide public health emergency exists and has existed since January 27, 2020 [15]. On March 13, 2020, therefore, with both the Presiden tial proclamation and DHHS Secretary’s determination of the nationwide emergency and public health emer gency, respectively, both the above prerequisites were Amounts paid under fair and bona fide employment relationships, Reasonable payments for personal services provided to the entity or for other services unrelated to the provision of designated health services, Compensation under a legitimate “physician incentive plan,” such as by withholds, capitation, or bonuses in managed care, Reasonable payments to induce a physician to relocate to the hospital’s service area, Isolated transactions, such as a one-time sale of property or a practice, An arrangement that began before December 19, 1989, in which services are provided by a physician group but are billed by the hospital, and Reasonable payments by a physician for clinical laboratory services or for other items or services

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Source: Showalter JS. The Law of Healthcare Administration. Health Administration Press; 2012

and Medicaid programs in which a physician or entity has knowingly entered into an improper cross-referral arrangement or scheme designed to circumvent the self referral prohibition [8, 10], and monetary penalties of up to three times the amount of the claim plus a penalty of an amount between $5,000 and $10,000 per claim [8, 10]. A review of past literature presented the initiation, legislative developments, and regulatory history, and thereby, cumulated the evolution of the Stark Law from 1972 to 2006 [3]. Thereafter, numerous amendments of the above law have taken place owing to the rap idly evolving healthcare landscape. As examples, both the 2010 Affordable Care Act (ACA) and the ongoing COVID-19 pandemic has initiated and made effective specific changes of the above law. This paper has three research questions giving rise to three objectives. First, this review paper sequentially curates the above law’s evolution, from initiation to 2020. This is an attempt to chronologically tabulate its updates. Second, the present review describes initiatives and func tions pertaining to the evolution of the above law. Finally, it describes how the 2020 COVID-19 Stark Law blanket waivers (hereinafter, blanket waivers) support specific patient self-referrals, expand on the permissible ways of remuneration for self-referrals, and protect eligible phy sicians from legal sanctions contextual to the COVID-19 pandemic. There are two-fold objectives to curating developments of the Stark Law. First, to update past literature. Second, to further assist policy analysts identify any areas within the above law that may need amendments, if need be, as per their discretion, in the future. Finally, to discern how these blanket waivers financially and medicolegally buffer