The Trump Administration is issuing an unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic. Made possible by President Trump’s recent emergency declaration and emergency rule making, these temporary changes will apply immediately across the entire U.S. healthcare system for the duration of the emergency declaration. The goals of these actions are to 1) expand the healthcare system workforce by removing barriers for physicians, nurses, and other clinicians to be readily hired from the community or from other states; 2) ensure that local hospitals and health systems have the capacity to handle a potential surge of COVID-19 patients through temporary expansion sites (also known as CMS Hospital Without Walls); 3) increase access to telehealth in Medicare to ensure patients have access to physicians and other clinicians while keeping patients safe at home; 4) expand in-place testing to allow for more testing at home or in community based settings; and 5) put Patients Over Paperwork to give temporary relief from many paperwork, reporting and audit requirements so providers, health care facilities, Medicare Advantage and Part D plans, and States can focus on providing needed care to Medicare and Medicaid beneficiaries affected by COVID-19.
•Hospital Outpatient Services Accompanying Professional Services Furnished ViaTelehealth: When a physician or nonphysician practitioner who typically furnishesprofessional services in the hospital outpatient department furnishes telehealth servicesduring the COVID-19 PHE, they bill with a hospital outpatient place of service since thatis likely where the services would have been furnished if not for the COVID-19 PHE. Thephysician or practitioner is paid for the service under the PFS at the facility rate, whichdoes not include payment for resources such as clinical staff, supplies, or officeoverhead since those things are usually supplied by the hospital outpatient department.During the COVID-19 PHE, if the beneficiary’s home or temporary expansion site isconsidered to be a provider-based department of the hospital, and the beneficiary isregistered as an outpatient of the hospital for purposes of receiving telehealth servicesbilled by the physician or practitioner, the hospital may bill under the PFS for theoriginating site facility fee associated with the telehealth service.
CMS Hospital Without Walls (Temporary Expansion Sites)
•Hospitals Able to Provide Care in Temporary Expansion Sites: As part of the CMS HospitalWithout Walls initiative, hospitals can provide hospital services in other healthcarefacilities and sites that would not otherwise be considered to be part of a healthcarefacility; or can set up temporary expansion sites to help address the urgent need toincrease capacity to care for patients. In the absence of waivers, hospitals are requiredto provide services to patients within their hospital departments. Hospitals have sharedconcerns about capacity for treating patients during the COVID-19 PHE, especially thoserequiring ventilator and intensive care services. CMS is providing additional flexibilities
for hospitals to create surge capacity by allowing them to provide room and board, nursing, and other hospital services at remote locations or sites not normally considered parts of healthcare facilities, such as hotels or community facilities. This flexibility will allow hospitals to separate COVID-19 positive patients from other non-COVID-19 patients to help efforts around infection control and preservation of personal protective equipment (PPE). For example, for the duration of the COVID-19 PHE, CMS is allowing hospitals to screen patients at offsite locations, and furnish inpatient and outpatient services at temporary expansion sites. Hospitals would still be expected to control and oversee the services provided at an alternative location. CMS also is offering some additional flexibilities to furnish inpatient services under arrangements during the PHE.
• Under the Hospitals without Walls initiative, CMS relaxed certain conditions of participation (CoPs) and provider-based rules for hospital operations to maximize hospitals ability to focus on patient care. The same initiative also allows currently enrolled ambulatory surgical centers (ASCs), to temporarily enroll as hospitals and to provide hospital services to help address the urgent need to increase hospital capacity to take care of patients. Other interested entities, such as independent licensed emergency departments, could pursue enrolling as a hospital during the PHE. ASCs that wish to enroll to receive temporary billing privileges as a hospital should call the COVID-19 Provider Enrollment Hotline to reach the contractor that serves their jurisdiction, and then will complete and sign an attestation form specific to the COVID-19 PHE. See https://www.cms.gov/files/document/provider-enrollment-relief-faqs-covid-19.pdf for additional information.
• Off Site Patient Screening: CMS is partially waiving the enforcement of section 1867(a) of the Social Security Act (the Emergency Medical Treatment and Active Labor Act, or EMTALA). This will allow hospitals, psychiatric hospitals, and critical access hospitals (CAHs) to screen patients at a location offsite from the hospital’s campus to prevent the spread of COVID-19, so long as it is not inconsistent with the state emergency preparedness or pandemic plan.
o 42 CFR §482.13(d)(2) with respect to timeframes in providing a copy of a medical record.
42 CFR §482.13(h) related to patient visitation, including the requirement to have written policies and procedures on visitation of patients who are in COVID-19 isolation and quarantine processes.
• Physical Environment: CMS waived certain requirements under the conditions at 42 CFR §482.41 and §485.623 to allow for flexibilities during hospital, psychiatric hospital, and CAH surges. CMS will permit non-hospital buildings/space to be used for patient care and quarantine sites, provided that the location is approved by the State (ensuring safety and comfort for patients and staff are sufficiently addressed). This allows for increased capacity and promotes appropriate cohorting of COVID-19 patients.
o Adopting a temporary extraordinary circumstances relocation exception policy for on-campus PBDs and excepted off-campus PBDs that are relocating off-campus during the COVID-19 PHE. Under our existing extraordinary relocation exception policy, only relocating off-campus PBDs are eligible to request this exception.
Streamlining the process during the COVID-19 PHE for relocating PBDs to seek the extraordinary circumstances exception so they can start seeing patients and billing for services immediately in the relocated PBD.
Allowing PBDs to relocate into more than one PBD location, and allowing PBDs to partially relocate while still maintaining the original location. Hospitals can relocate PBDs to the patient’s home and continue to receive the full OPPS payment amount under the extraordinary circumstances relocation exception policy.
Note regarding Payment for Certain Provider-Based Departments (PBDs) During the PHE: Hospital waivers do not impact the payment rates for covered hospital outpatient items and services, including whether the PBD is paid under the Physician Fee Schedule (PFS)- equivalent rate or under the Outpatient Prospective Payment System (OPPS) under Section 603 of the Bipartisan Budget Act of 2015.
Under section 603 rules, most new off-campus PBDs are typically paid at the Medicare PFS-equivalent rate instead of the rate determined under the OPPS. CMS has determined through rulemaking that the PFS-equivalent rate to be 40% of the OPPS rate. Most PBDs that relocate are also subject to the lower rate, unless they are eligible to seek and are approved for an extraordinary circumstances relocation exception.
CMS has made several changes to support hospitals so they can more effectively respond to the COVID-19 PHE. These changes include: 4/29/2020 4