COVID-19: Identifying Risks, Determining Focus & Setting Priorities
The regulatory and operational environment is evolving by the day, and providers have been forced to draw upon contingency and emergency plans. Arent Fox’s Health Care Group has been following COVID-19 legal and regulatory developments closely, advising our clients on legal and business issues raised by the challenge, and publishing on new developments regularly. In this high-level Alert, we identify relevant areas of focus for healthcare providers, address immediate priorities, and share suggestions for risk planning.
Emergency Department Screening for COVID-19
The Emergency Medical Treatment and Labor Act (EMTALA) requires Medicare-certified hospitals to conduct medical screening examinations of all individuals who come to the hospital’s emergency department (ED) and request medical evaluation or treatment. This requirement includes individuals suspected of infection with COVID-19, and applies regardless of the individual’s mode of arrival (walk-in, ambulance, etc.). After screening, hospitals must then provide necessary stabilizing treatment if the individual has an emergency medical condition, and provide appropriate transfers when necessary.
The Centers for Medicare and Medicaid Services (CMS) has issued a letter to state hospital licensing agencies regarding application of EMTALA to COVID-19. CMS’s letter reiterates basic EMTALA requirements and addresses the various locations where screening for influenza-like illness (ILI) may be conducted, including alternative screening sites on a hospital campus; screening at off-campus, hospital-controlled sites; and community screening clinics at sites not controlled by the hospital.
CMS states a hospital may use an alternative site on its campus for performing the medical screening examination, instead of performing the examination in the ED. Hospital personnel may redirect the individual to the alternative site after being logged in, and the redirection and logging may take place outside the entrance to the ED. Hospital personnel performing the redirecting must be qualified to recognize individuals who are in need of immediate care. If individuals are found to have an emergency medical condition, EMTALA requirements apply, and the hospital must provide stabilizing treatment or an appropriate transfer.
Hospitals may also set up screening at an off-campus, hospital-controlled site. The hospital may generally encourage the public to go to these sites for ILI screening; however, the hospital may not tell individuals who have already come to the ED to travel to the off-site location for a medical screening examination. EMTALA requirements do not generally apply to these off-campus sites unless they are already considered a dedicated ED of the hospital under EMTALA. Still, the hospital is required to arrange referral or transfer if an individual needs additional medical attention on an emergent basis.
Finally, communities may set up ILI screening clinics at locations not under the control of a hospital. EMTALA does not apply at these clinics. Hospitals may encourage the public to travel to these clinics instead of the hospital for ILI screening. Still, a hospital may not send individuals who have already come to the ED to the clinic for a medical screening examination.
Hospitals should carefully analyze the distinctions between various types of screening sites and how EMTALA applies depending on the screening location, including appropriate signage for individuals arriving for screening.
CMS also addresses in its letter the possibility of EMTALA waivers. The waivers would allow a hospital to direct individuals coming to the ED to an off-campus site for medical screening examinations, provided that the hospital acts in accordance with applicable state emergency or pandemic preparedness plans. The hospital would also be permitted to transfer individuals with unstable medical conditions which the hospital would otherwise be required to treat, provided that the transfers are a necessary result of the COVID-19 emergency. CMS will provide notice of EMTALA waivers to hospitals through its Regional Offices or the state hospital licensing agencies.
Updates to the requirements regarding the provision of telehealth services to Medicare beneficiaries are among the most significant recent developments. Medicare currently reimburses providers for certain real-time audio-visual services provided to patients. Both the provider and the patient must be located in specific geographic locations that are mainly rural areas. The Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020 and other guidance from CMS waived geographical restrictions on the location of patients so that beneficiaries will be eligible to receive telehealth services in any health care facility, including a physician’s office, hospital, nursing home, or rural health clinic, as well as in the beneficiaries’ homes, regardless of whether the location is in an urban or rural area.
Providers may also consult with patients via smartphone, provided that the device has real-time audio/visual capabilities, such as FaceTime or other applications. Finally, a number of states have waived or relaxed licensure requirements for out-of-state providers who treat in-state residents.
Provider Locations and Enrollment
CMS will temporarily waive requirements that out-of-state providers be licensed in the state where they are providing services, so long as they are licensed in another state in the United States. This waiver applies only to providers certified by the Medicare and Medicaid programs. State law may separately require that providers be licensed in the state where they are providing services; still, some states may permit practice by providers licensed in another state as an emergency measure.
CMS will establish a toll-free hotline for non-certified suppliers, physicians, and non-physicians to enroll and receive temporary Medicare billing privileges. CMS will also waive certain Medicare screening requirements, including the application fee, certain criminal background checks, and site visits. In addition, CMS will postpone revalidation actions; allow licensed providers to render services outside their state of enrollment; and expedite pending and new provider applications.
Healthcare Operations and Infection Control
Significant challenges for healthcare providers involve shortages in the supply chain, and staffing and space for pandemic response. Many hospitals have responded by canceling elective procedures, seeking additional staff members, and planning for alternative screening sites for potential COVID-19 patients. The Department of Health and Human Services (HHS) has also provided guidance to providers regarding infection control and other procedures, and in some cases, regulatory flexibility.
- Infection Control. CMS has provided guidance to hospitals and other providers regarding infection control and prevention, and urged those providers to follow the Center for Disease Control’s guidelines for healthcare workers.
- Agency or Registry Staff. Nursing agency or other temporary staff members typically rotate between facilities; therefore CMS has asked nursing facilities to identify those staff members, as they present a higher risk of infection. The staff should be actively screened and appropriate restrictions implemented to mitigate infection risk.
- Visitation. CMS has instructed nursing homes to restrict visitation and non-essential health care personnel from entering the facility, except for certain compassionate care situations such as end-of-life. However, the compassionate care guidelines do not apply for visitors with symptoms of a respiratory infection, who CMS instructs should not be permitted to enter the facility at any time, including in end-of-life situations.
- Medical Staff and Other Healthcare Practitioners. Despite regulatory flexibility for pandemic response, hospitals and other providers remain obligated to ensure care is provided in a safe manner by licensed and credentialed professionals. Some states’ health care practice acts already contain provisions addressing staffing in the case of an emergency, such as permitting physicians licensed in another state to provide care to patients, or allowing flexibility in supervision of physician assistants.
Patient Data Privacy and Security
To speed the coordination of telehealth and patient appointments, HHS has announced that certain – and very limited – provisions of the Health Insurance Portability and Accountability Act (HIPAA) will be waived under certain – and very specified – circumstances.
The waivers only allow certain privacy provisions to be lifted for 72 hours from the time a health care provider institutes a disaster protocol. Under the waivers, providers are not required to release a copy of their privacy practices or acknowledge patients’ rights to request confidential communications or privacy restrictions. Upon the earlier of 72 hours or the end of the emergency declaration, providers must resume compliance with all of HIPAA’s privacy provisions.
Critical Access Hospitals
CMS-designated Critical Access Hospitals (CAHs) are rural hospitals containing 25 beds or less that are afforded certain regulatory and payment flexibility. CMS has implemented a blanket waiver applicable to all CAHs that lifts the 25-bed cap and permits stays in excess of 96 hours. This is a significant benefit to rural areas; however, CMS still recommends CAHs notify the applicable state hospital licensing agency and CMS Regional Office if operating in accordance with the waiver provisions to ensure no interruption in reimbursement.
CMS has taken steps to expand reimbursement for laboratories testing for the COVID-19 virus. Two Healthcare Common Procedure Coding System (HCPCS) codes are now available for use by laboratories for the testing and tracking of new cases of COVID-19. Laboratories testing patients for COVID-19 using the CDC’s test will receive about $36 per test in Medicare reimbursement, while those testing with non-CDC test kits will receive approximately $51 per test.
Continuing CMS Updates
CMS is taking steps to be transparent and share information broadly regarding its efforts against COVID-19 by posting stakeholder calls. Among these, CMS held a National Stakeholder Call on March 13, 2020, to update the healthcare community on COVID-19 following a national emergency declaration by President Trump. The transcript and audio recording from that call are available online, and CMS will hold future calls and post transcripts and audio recordings as they become available.
Business, Insurance, and Other Operational Concerns
As hospitals and other providers navigate both their and their contractors’ obligations to provide equipment, supplies, and services on an emergency basis, they may encounter a variety of business, insurance, contract, or payment issues. These could include, among others, force majeure; business interruption; the inability to collect, or significant delay in collecting payments; difficulty making payments; challenges dealing with partners and vendors who are in distress; the inability to close financing or funding transactions; liquidity concerns and access to capital; delays and breakdown of supply chain; and other operational challenges. Arent Fox attorneys can discuss all of these issues and help develop strategies tailored to each individual client and the circumstances as the situation evolves.
Ongoing, Open Questions
Many questions remain with respect to health care provider staffing for COVID-19 with few easy answers. Can staff get to work? Will they come? If not already credentialed, can the credentialing process be expedited on an emergency basis? How should the issue of facility volunteers be addressed? Are staff functioning within their licensure and skill set, and do work-hour limitations apply for different types of staff? Hospitals and other providers need to ensure, under some of the most challenging conditions, that health care services continue to be provided in a safe and appropriate manner.