The temporary changes apply immediately across the U.S. healthcare system.

Hospitals without walls, the USNS Comfort and FaceTime calls between patients and doctors are just some of the new and much-needed initiatives to fight the COVID-19 pandemic that are now possible because the Centers for Medicare and Medicaid Services (CMS) is relaxing laws and regulations.

On March 30, 2020, CMS, in coordination with the Trump administration, announced the implementation of a sweeping array of new rules and waivers of federal requirements for hospitals and health systems to effectively manage potential surges of COVID-19 patients.

CMS’ most recent initiatives include efforts to increase hospital capacity, expand the healthcare workforce, eliminate paper requirements for clinicians and further promote telehealth services. The temporary changes apply immediately across the U.S. healthcare system and should remain in effect for the duration of President Trump’s emergency declaration.

These important measures follow New York’s efforts to convert convention centers and other buildings into temporary hospitals. More recently, President Trump approved New York’s request to begin using the Javits Center―a convention center in Hudson Yards, Manhattan―as an emergency medical facility with 2,500 beds to treat COVID-19 patients. In upstate New York, Erie County officials and the Army Corps of Engineers toured the Buffalo Niagara Convention Center to determine its suitability as a temporary emergency hospital. At this point, the temporary expansion sites will likely be used for noncritically ill patients or those transferred to accommodate and separate COVID-19 patients.

Increased Flexibilities for Hospitals

Increase Hospital Capacity – CMS Hospitals Without Walls Initiative

Under CMS’ new “hospitals without walls” initiative, hospitals are permitted to create new treatment sites in areas such as dormitories, gymnasiums, ambulatory surgery centers, inpatient rehabilitation hospitals and hotels. In an effort to separate COVID-19 patients from non-COVID-19 patients, the temporary rules permit hospitals to set up temporary expansion sites and transfer patients who require less intensive care while using inpatient beds for COVID-19 patients.

Additionally, the new flexibilities permit hospitals to bill for services provided offsite, screen patients at offsite locations, and furnish inpatient and outpatient services at temporary expansion sites.

Specifically, CMS waived the enforcement of certain laws and regulations:

• Off-Site Patient Screening: CMS is waiving the enforcement of § 1867(a) of the Social Security Act (the Emergency Medical Treatment and Active Labor Act, or EMTALA), allowing hospitals to screen patients at offsite locations to prevent the spread of COVID-19.
• Paperwork Requirements: CMS is waiving certain paperwork requirements for hospitals impacted by a widespread outbreak of COVID-19, allowing hospitals to establish COVID-19-specific areas. Hospitals located in states with widespread confirmed cases are not required to meet the mandates of 42 CFR § 482.13(d)(2) (timeframes for providing copies of medical records), 42 CFR § 482.13(h) (written policies for COVID-19 patient visitation) and 42 CFR § 482.13(e)(1)(ii) (regarding seclusion).
• Physical Environment: CMS has waived certain requirements under 42 CFR § 482.41 and § 485.623, permitting nonhospital buildings and spaces to be used for patient care and quarantine sites.
• Temporary Expansion Sites: CMS has waived Medicare conditions of participation in 42 CFR § 482.41 and § 485.623, and for provider-based department requirements under 42 CFR § 413.65, thereby allowing hospitals to establish locations that operate as part of the hospital and change the status of current provider-based department locations.
• Critical Access Hospital Length of Stay, Status and Location: Waiver of Medicare requirements that Critical Access Hospitals (CAHs) limit the number of beds to 25 and length of stay to 96 hours (42 CFR § 485.620). CMS is also waiving the requirement that CAHs be located in rural areas (42 CFR § 485.610(b), (e)).
• Telemedicine: Waiver of regulatory provisions related to telemedicine for hospitals and CAHs (42 CFR § 482.12(a)(8-9), § 485.616(c)), easing the provision of telemedicine services to the hospital’s patients through an agreement with an off-site hospital.

Patients Over Paperwork Initiative for Hospitals

CMS has also waived certain regulatory paperwork requirements so that providers and hospitals can treat patients more efficiently during surge situations.

The paperwork flexibility measures include waivers of verbal order requirements, certain cause of death reporting requirements and discharge planning requirements. Additionally, CMS has relaxed requirements relating to medical records, including certain waivers for staffing of records departments, the required contents and due dates for records, and retention policies. CMS is also waiving certain signature requirements, emergency preparedness policies and utilization review plan requirements for the duration of the emergency.

The recent CMS measures also include flexibilities, extensions and waivers related to Medicare appeals in Fee for Service, Medicare Advantage and Part D.

Hospital Workforce Flexibilities

CMS’ new flexibilities permit hospitals to utilize sterile compounding, which allows hospitals to sterilize and reuse face masks. CMS will also permit physicians whose privileges will expire to continue practicing, and allow hospitals to use practitioners other than physicians (e.g., physician’s assistants and nurse practitioners) to care for Medicare patients. Certified registered nurse anesthetists (CRNAs) in hospitals, critical access hospitals and ambulatory surgery centers do not need to be supervised by a physician during the COVID-19 emergency. Supervision will now be at the discretion of the hospital, the ambulatory surgery center and state law. Additionally, CMS’ measures permit flexibility in critical access hospital personnel qualifications and staff licensure.

Increased Flexibilities for Physicians and Other Clinicians

In order to ensure hospitals and health systems have sufficient capacity to handle COVID-19 patient surges and can rapidly expand the healthcare workforce, CMS and the Trump administration also announced federal regulatory flexibilities to remove hiring barriers for physicians, nurses and other clinicians. Additionally, CMS’ measures are intended to increase the provision of telehealth, expand in-place, community or home-based testing and provide temporary relief from paperwork and reporting requirements.

Telehealth, Virtual Check-Ins and Remote Patient Monitoring

The new regulatory flexibilities have expanded the range of services clinicians are permitted to provide via telehealth. CMS has indicated which HCPCS and CPT codes clinicians should use for services rendered through telehealth.

Clinicians may now provide virtual check-in services and remote patient monitoring to both new and established patients. Additionally, face-to-face visit requirements and frequency limitations for certain services provided by Medicare telehealth have been removed, including for subsequent inpatient visits and subsequent skilled nursing facility visits.

Workforce Flexibilities

The new measures permit Medicare physician supervision to occur virtually using real-time audio-visual technology. Direct physician supervision is no longer required for certain services, including nonsurgical extended duration therapeutic services provided in hospital outpatient departments and critical access hospitals.

CMS has temporarily waived Medicare and Medicaid’s requirements that practitioners be licensed in the state where they provide services, subject to certain limitations, although state requirements will still apply.

Conclusion

When we consider the Javits Center opening up 2,500 beds for COVID-19 patients, universities donating their soccer fields to set up treatment tents or emergency screening in patient parking lots, the creativity and ingenuity that healthcare facilities and providers are demonstrating is remarkable. CMS is recognizing the need for a regulatory framework that allows our healthcare providers, facilities and patients to fight the COVID-19 as effectively and rapidly as possible.

About Duane Morris

Duane Morris has created a COVID-19 Strategy Team to help organizations plan, respond to and address this fast-moving situation. Contact your Duane Morris attorney for more information. Prior Alerts on the topic are available on the team’s webpage.

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