- Federal and state waivers have lifted a range of restrictions on hospitals during the coronavirus outbreak.
- Hospitals should ensure they are compliant with redundant state requirements in cases where federal rules are suspended.
- Federal requirements remain unchanged in many critical areas, such as rules from the Occupational Safety and Health Administration.
Federal and state governments have given hospitals some legal protections in responding to COVID-19 cases, but pitfalls remain, legal experts say.
Hospitals are scrambling to understand their current legal rights and responsibilities amid their responses to the coronavirus outbreak and changing rules and regulations in areas such as telemedicine, patient privacy, HIPAA and hospital operations, according to legal advisers.
“Our healthcare clients are racing to keep up with what’s possible, so that they can adjust what they are doing to provide the best care they can during an unprecedented surge of patients with these respiratory illnesses,” said Sandra DiVarco, JD, a partner for McDermott Will & Emery.
Waiver-driven flexibility
The March 13 national emergency declaration allowed the U.S. Department of Health and Human Services to begin providing Section 1135 Medicaid waivers, which Florida and Washington state so far have received. The Washington waiver included a temporary end to some prior-authorization requirements for services provided to fee-for-service Medicaid beneficiaries.
On March 13, the Centers for Medicare and Medicaid Services (CMS) also began issuing blanket waivers and requirement modifications that applied broadly to providers. The areas affected by the blanket waivers have included:
- Lifting limits on the number of beds and duration of stay at critical access hospitals
- Suspending restrictions on where hospitals can place acute care patients within their facilities
- Suspending provider-location licensure requirements
CMS waivers also have allowed for new operational approaches, like erecting exterior tents to screen for coronavirus at emergency departments, said Sarah Swank, JD, a counsel for Nixon Peabody.
Other waivers will apply to EMTALA requirements around patient transfers in instances when there is both a federal and state emergency declaration. For instance, hospitals will be able to move patients who have not yet been stabilized to another hospital or to emergency treatment centers being created during the pandemic, Swank said.
Beyond EMTALA, hospitals also will need to ensure they are compliant with patient transfer rules for their own state, as possibly modified by state emergency declarations, Swank said.
Individual hospitals seeking regulatory relief beyond the blanket waivers but within the scope of the Section 1135 waiver authority have begun to submit waiver requests to CMS that include justifications based on their specific circumstances, DiVarco said.
“Clients we are speaking with almost daily are right now assessing as the wave begins, what they are going to need,” DiVarco said.
She was unaware of any waiver requests that have been denied.
Several state hospital associations also have submitted waivers on behalf of all member hospitals, she said.
Hospitals also are seeking waivers of state requirements. Texas on March 20 approved a waiver for its hospitals to increase bed capacity “without a fee or application” beyond their licensed limits during the “state of disaster” if they experience a surge, according to the state’s approval letter.
The CMS waiver has raised concerns among hospital leaders because it suspends HIPAA requirements for only a short period, said Scott Weinstein, JD, another partner at McDermott Will & Emery. The waiver allowed only a 72-hour suspension of HIPAA requirements following hospitals’ activation of their disaster plans, many of which were activated weeks ago.
Hospital leaders have asked congressional representatives to extend the suspension, Weinstein said.
A big change for telehealth
On March 15, CMS issued a major temporary change in Medicare telehealth rules, including:
- Suspending originating-site requirements
- Suspending requirements that patients have an established relationship with the provider delivering the care
- Suspending restrictions on what types of technology can be used for a telehealth encounter
- Providing payments equal to in-person care
The telehealth waiver, which will last until the announced end of the national emergency, also included a suspension of enforcement by the CMS Office of Civil Rights (OCR).
“The idea is for healthcare providers to be able to use their own personal devices to engage in these visits, rather than having to invest, necessarily, in new equipment,” Weinstein said. “Of course, that raises security concerns.”
Although the OCR enforcement suspension provides a legal buffer for hospitals in the context of HIPAA, he said, they still need to use the allowed technology “in a manner that doesn’t jeopardize patients’ health information.”
CMS also lifted requirements that to be paid by Medicare, clinicians must have a license to practice in the state in which they are practicing. However, states retain authority to decide whether out-of-state clinicians can practice in the state, and only a few have suspended licensure requirements due to the coronavirus.
Other potential legal pitfalls
Critically, the Occupational Safety and Health Administration (OSHA) has not suspended its regulations, and hospitals need to try to adhere to those, even as some lack personal protective equipment, Swank said. Some states have additional OSHA-type requirements with which hospitals also will need to continue to comply.
Legal liabilities also remain unclear amid federal guidelines urging hospitals to avoid, delay or cancel elective surgeries, to free personnel, space and equipment for a possible surge of coronavirus-related intensive care cases.
A few states have ordered cancellation of elective procedures. But where hospitals have undertaken voluntary cancellations, they at least should ensure those are clearly communicated to the public and echo medical society recommendations, Swank said.
