Legal and Compliance Issues in Healthcare 2021

Legal and compliance issues in healthcare are numerous, complex and constantly changing. The regulatory issues have evolved over the years and in 2020, the pandemic created even more legal and compliance issues for healthcare providers – some of them temporary and some permanent. 

New and Emerging Issues in 2021

The pandemic drove some changes in the way virtually every healthcare provider delivered care. There were significant changes in virtually every care setting from acute care hospitals to physician office practices to skilled nursing facilities. 

Virtual Healthcare:

Telehealth emerged as a solution for providers who wanted to be able to see patients without exposing patients and themselves to COVID-19. Before 2020, telehealth was a fairly rare exception in most care settings, but the pandemic drove physician office patients and their providers to virtual care. Most new regulation around telehealth revolved around removing barriers to telehealth including those related to reimbursement. There are now new codes from the Centers for Medicare and Medicaid Services (CMS) to report telehealth services and request reimbursement. CMS also granted emergency waivers for telehealth services which gave patients even greater access to telehealth services. Early indications are that telehealth will remain an option for patients and their providers even after the pandemic is finally in our rear view mirror. 

Long-term Care and Skilled Nursing Facilities:

The impact of COVID-19 was perhaps felt most painfully in these facilities. In 2020, most nursing facilities were inspected by CMS and most will be inspected again in 2021. CMS has updated its guidance on visitation, but as new strains of the virus emerge, it is likely that guidance will change again and become more restrictive. In addition, the Centers for Disease Control (CDC) has added additional reporting requirements for these providers. The CDC now requires weekly reporting of COVID-19 metrics such as confirmed cases and deaths among residents and staff, staffing shortages, availability of PPE, availability of ventilators, resident census data and updates on the availability of COVID-19 testing for both residents and staff. These facilities also need a plan to provide current metrics on the number of confirmed and suspected cases of the virus among residents and staff within a prescribed time frame.

Healthcare Inequity Issues:

The pandemic has made disparities in access, medical care and outcomes much more apparent. Countless health systems, municipal governments and professional associations have declared racism in healthcare a public health crisis. Increased equity in healthcare outcomes will likely become the focus of future regulation. This is a broad area and includes improving the diversity of leadership in healthcare, offering training for providers on how to recognize and deal with both conscious and unconscious barriers to healthcare and focusing on the social determinants of health status to improve healthcare outcomes for minority groups.

Interoperability Risks in Healthcare:

Electronic Health Records (EHR) and increasing needs for data sharing and reporting has increased the vulnerability of healthcare data. The data is driving important clinical and business decisions and innovations in care and treatment for patients. In addition, consumers also have expectations about how they should be able interact with their own medical records and providers as evidenced by the ever-increasing numbers of healthcare apps and patient portals. Compliant data sharing will be a focus of the Office of the Inspector General (OIG).

Protected Health Information (PHI):

While there have been no recent changes to the Health Insurance Portability and Accountability Act (HIPAA), the Office of Civil Rights (OCR) announced a new proposal at the end of 2020 that will grant greater access to PHI by patients and may reduce the amount of time in which providers will need to respond to patient requests for PHI. As this will be an ongoing legal and compliance issue, make sure that your organization is protecting information, assets and people while remaining in compliance with the newest requirements. 

Vaccination Issues:

2020 was the year that a pandemic and an anti-vaccine sentiment collided. In the absence of governmental mandates requiring the vaccine, many healthcare organization have created their own mandates requiring vaccines. Because the Equal Employment Opportunity Commission has declared COVID-19 a “direct threat”, healthcare providers will have more latitude to create and enforce vaccine mandates. In addition, healthcare organizations will need to remain updated on reimbursement for the vaccines and the latest guidance on boosters.