Seyfarth Synopsis: With coronavirus infections continuing to spread both in the US and abroad, fears of a pandemic with serious disruptions to the economy and everyday life continue to grow. Concerns are compounded for healthcare providers and facilities, who are not only employers but are also in the front lines of the response. An outbreak among healthcare professionals and those who work with providers and facilities not only impacts their finances, but can cascade into a larger healthcare crisis. Below we present a series of recommendations and other guidance focused on helping healthcare providers and facilities to prepare for a potential pandemic.
Recent CMS and CDC Guidance
Since the beginning of February 2020, as concerns about coronavirus reaching the US began to grow, both the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) have published guidance specifically for healthcare providers and facilities. The CDC's guidance appears in three documents, (1) Interim U.S. Guidance for Risk Assessment and Public Health Management of Healthcare Personnel with Potential Exposure in a Healthcare Setting to Patients with Coronavirus Disease 2019 (COVID-19) ("Interim Guidance"), (2) Interim Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) or Persons Under Investigation for COVID-19 in Healthcare Settings ("Infection Control Guidance"); and (3) Coronavirus Disease 2019 (COVID-19) Hospital Preparedness Assessment Tool (the "Assessment Tool"). The Interim Guidance contains a rubric for categorizing personnel based on their risk of exposure, as well as recommendations for monitoring and work restrictions (even for asymptomatic individuals). The Infection Control Guidance sets forth specific recommendations aimed at healthcare facilities and providers focused on the following areas: minimizing exposure, training, use of personal protective equipment (PPE), visitation and access, engineering controls, personnel management, environmental controls and reporting. The Assessment Tool is a useful checklist of elements to be assessed and actions taken by professionals and facility personnel to prepare for a pandemic.
The CMS guidance, Information for Healthcare Facilities Concerning 2019 Novel Coronavirus Illness (2019-nCoV) (Ref: QSO 20-09-ALL) ("CMS Guidance") references the CDC guidance above and adds that infectious diseases should be addressed in a provider's emergency preparedness plans and policies, which are required under recent regulations. CMS also adds a warning that state and federal facility surveyors (i.e. inspectors) are being trained and advised to closely observe facility staff hand hygiene practices, violations of which could lead to sanctions, penalties or other disruptions in licensure or Medicare/Medicaid program participation.
Advice for Healthcare Providers and Facilities as Employers
Healthcare providers and facilities not only have obligations to their patients and the public at large, but also to their own employees. All employers in the US have a "general duty" under the Occupational Safety and Health Act to provide a "safe and healthful workplace." Where there is a "recognized hazard" (such as a pandemic), employers must develop plans to protect employees. Importantly, in healthcare facilities, this obligation extends to employees or contractors of other entities who perform work at the hospital (e.g. members of the hospital medical staff). Other potential areas of intersection with employer liabilities include: worker's compensation programs, disability benefits, Family and Medical Leave Act benefits, the American with Disabilities Act, and general premises liability (which may be mitigated via insurance). Additional detail on the above can be found in our Legal Update on Coronavirus: Employer Liability Issues. Note also that the materials form our comprehensive webinar are available. See the Coronavirus webinar presentation slides and the presentation recording.
While managing high-risk and high stakes patients and medical conditions such as coronavirus, providers and facilities must also keep in mind their HIPAA obligations to keep patient health information private and secure. The Department of Health and Human Services Office of Civil Rights (OCR) recently issued a bulletin to remind healthcare providers and facilities of their obligations under HIPAA. The OCR reiterated that "covered entities" (and in some cases, their business associates) may use or disclose patient information for treatment purposes, to public health authorities (CDC, local or state health department), and (with a patient's permission) to family members and others involved in the patient's care. In limited circumstances, a covered entity can disclose information to others as necessary to prevent a serious and imminent threat, but this disclosure is only permitted to those in a position to prevent or mitigate the threat. Importantly, health care providers and facilities may not release information about a particular identifiable patient to the media without the patient's consent or other limited and specific circumstances. A pandemic outbreak does not excuse a facility from observing the required HIPAA security safeguards.
Following the CMS and CDC guidance and other prudent advice, it is recommended that all healthcare providers and facilities do the following:
- Review infection control and prevention policies and procedures;
- Additional training for all personnel, management and leadership on infection control, hand hygiene and other aspects of pandemic response;
- Review and update, as necessary, emergency preparedness plans to include contingencies for pandemic outbreaks;
- Review inventory of PPE (including masks and gloves for patients and others in waiting areas);
- Planning and additional training for public relations and media personnel regarding disclosure or release of information about infected or potentially infected patients;
- Evaluate telemedicine capabilities and capacity to continue to operate if key personnel are infected or quarantined, as well as circumstances when locations need to be closed;
- Assess telephone and receptionist scripts to assure uniform response and presentation to patients;
- Assess workforce for risk factors and exposure, as well as regular monitoring and observation of employees and other personnel, particularly those with identified risk factors;
- Evaluate the need to adjust and space scheduling of patients to minimize contact; and
- Discuss pandemic preparation with ancillary service providers and recipients of referrals (e.g. labs, imaging, etc.).
All levels of leadership and management of healthcare providers and facilities (up to and including its governing body) should be regularly and actively engaged in planning, reporting and responding to potential coronavirus infections and precautions within that organization.
Many thanks to Clifford C. Dacso, M.D. of Baylor College of Medicine, for his assistance in preparing this article.
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