State-Issued COVID-19 Waivers and Emergency Rules
Updated: August 13, 2020
As the COVID-19 outbreak has progressed, states have begun to review their laws and regulations to determine what could be waived to assist the healthcare system in its response to the pandemic. On the evening of March 30, the Centers for Medicare & Medicaid Services (CMS) announced sweeping regulatory changes designed to prepare the US healthcare system to address the expected patient surge from the outbreak. Included in the CMS “Hospitals Without Walls” program are provisions that would allow ASCs to contract with local healthcare systems to provide hospital services, or allow them to enroll and bill as hospitals during the emergency declaration as long as they are not inconsistent with their state’s Emergency Preparedness or Pandemic Plan. ASCA is tracking these waivers and emergency rule changes as states continue to look for ways to allow ASCs to play a role in the pandemic response.
Currently, eight states have made emergency rule changes or granted waivers as part of their pandemic response either directly addressing ASCs or significantly affecting ASCs.
This resource will continue to be updated as the situation develops. All questions or new information should be directed to Stephen Abresch.
The Arkansas Department of Health issued rules for hospitals and related institutions to allow ASCs in the state to take part in the Hospitals Without Walls program. “Arkansas licensed ambulatory surgery center in good standing with the state and CMS may apply for a temporary hospital license. The temporary hospital license is dependent upon an application, and attestation that all hospital basic requirements are met, with the one exception of operation of an emergency department. The temporary hospital license for an Ambulatory Surgery Center is applicable only during the Governors Executive Order 20-03 and as amended by Executive Order 20-16, or any future Executive Order renewing the disaster and public health emergency specific to Covid-19. The temporary license is immediately terminated at the cessation of the Executive Order 20-03 , as amended by Executive Order 20-16 ,or any future Executive Order renewing the disaster and public health emergency specific to Covid-19.” In Executive Order 20-25, issued on May 5, Governor Hutchinson provided that, “Executive Order 20-03 and all amendments thereto, not specifically superseded by this order or a prior order, shall remain in effect for the duration of the emergency.”
On April 8, the Health Facilities and Emergency Medical Services Division of the Colorado Department of Public Health & Environment issued a message to ASCs announcing that, in line with the waivers issued by CMS on April 3, the department “...is currently developing a state licensing process for ASCs wishing to enroll as licensed hospitals.” Interested facilities are directed to submit a letter of intent.
On April 14, the Indiana State Department of Health (ISDH) issued an emergency order granting temporary blanket waivers for ASCs in the state. The order provides that “All state rules governing Indiana-licensed ambulatory outpatient surgical centers (“ASCs”) as set forth at 410 IAC 15-2.1 through 410 IAC 15-2.7, and any application of the ISDH “Interpretive Guidelines” for ASCs, are waived for any ASC that is temporarily repurposed as a hospital in connection with the COVID-19 pandemic.” In addition, the order waives various requirements for ASCs not repurposed as hospitals, including requirements concerning ASC employees providing services at adjacent facilities, infection control committees, reuse of disposables, patient isolation, sterilization of equipment and supplies, entries in patient medical records and medical staff reappointments. The order provides that these waivers are effective as of March 6 and will expire “...upon the earliest of (a) expiration or withdrawal of the Governor’s Declaration, including any extensions thereof; (b) revocation of this Emergency Order; or (c) expiration of this Emergency Order under IC 4-21.5-4-5(a)(3), including any extensions thereof, plus such additional time as the ISDH deems necessary to enable an orderly transition by facilities back to compliance with the rules or parts of rules herein waived.”
On March 31, Governor Peter Ricketts issued executive order 20-12 to provide relief to hospitals and healthcare facilities and expand the use of telehealth services. Included in the order is a temporary waiver of NRS § 71-405, which requires ASCs to provide services to persons who are admitted to and discharged from the facility within the same working day and prohibits overnight stays. The order additionally temporarily suspends the provisions of 175 NAC § 7-006.12, which requires ASCs to meet all Medicare Conditions of Participation. The provisions of this order went into effect immediately and will remain in effect until 30 days after the lifting of the COVID-19 state of emergency.
On March 13, the New Jersey Department of Health released a memo to licensed ambulatory care facility (ACF) administrators and licensed adult and pediatric day care (APD) facility administrators announcing temporary operational waivers during the state of emergency declared due to the COVID-19 outbreak. The memo announces that “in the event of a State of Emergency as declared by the Governor of New Jersey in an Executive Order, that so significantly affects the ability of an ACF or APD to offer its full array of services or forces it to evacuate its patients/participants, or causes a licensed facility to accommodate evacuated patients/participants from another facility, the Department of Health (Department) will not require prior Department approval of temporary waivers for the following requirements for ACFs and APDs that are affected by such an event: 1. Physical space requirements; or 2. Staff qualifications requirements.” The memo additionally notes that affected ACFs and APDs "will be required to provide a written report to the Department detailing which, if any, of the above actions were implemented, the duration of the implementation, and any adverse outcomes attributable to the actions." The waiver will no longer apply once the state of emergency is ended, and “…ACFs and APDs will be required to return to the previously licensed capacity and to operate in accordance with all licensure standards.”
On April 8, Governor Roy Cooper issued an executive order to allow increases in healthcare resources to prepare the state for a surge in COVID-19 patients. Included in the order is a provision authorizing the secretary of Health and Human services to “...waive or modify enforcement of any legal or regulatory constraints that would prevent or impair...an ambulatory surgical facility to operate as a temporary hospital.” For an ASC to operate as a temporary hospital, the order requires that a request be submitted to, and approved by, the Division of Health Service Regulation (DHSR). Once approved, "DHSR must issue a temporary hospital license and the ambulatory surgical facility operating as a hospital must follow the applicable hospital laws and rules as determined by DHSR." The order also provides that a certificate of need will not be required for an ASC to operate as a temporary hospital. The changes in this order will be allowed only through the duration of the State of Emergency, with an additional 30-day grace period following the State of Emergency.
On March 27, Texas Health and Human Services Executive Commissioner Phil Wilson released a health facility licensing guidance letter announcing that ASCs in the state will “…now be permitted to expand their services beyond surgical services and keep patients for longer periods of time in response to the COVID-19 pandemic. ASCs must also now report to the Department of State Health Services (DSHS) the number of functioning ventilators and other respiratory support equipment at the ASC and any additional information required by DSHS.” Specifically, the emergency rules amend the definition of “ambulatory surgical center” under 25 TAC §135.2 to allow ASCs to provide other healthcare services to patients and remove the existing 23-hour limit on length of stay, and also amend the reporting requirements under 25 TAC §135.26 so that ASCs are not required to report to the Health and Human Services Commission the transfer of a patient to a hospital or a patient stay exceeding 23 hours. The guidance letter states that these emergency rules will not be effective for longer than 120 days and cannot be renewed for longer than 60 days.
On March 30, Governor Jay Inslee issued a proclamation that, in part, waives state laws and regulations governing its certificate of need (CON) program until midnight on April 29, 2020. These changes will directly impact ASCs in the state. The proclamation waives the provisions under RCW 70.38.105(4) subparagraphs a, b, e, g and h, which provide that a CON is required for, respectively: construction, development or other establishment of a new healthcare facility; the sale, purchase or lease of part or all of any existing hospital; a change in bed capacity of a healthcare facility which increases the total number of licensed beds if the bed redistribution is to be effective for a period in excess of six months; any expenditure for the construction, renovation or alteration of a nursing home; and any increase in the number of dialysis stations in a kidney disease center. Under RCW 70.38.025, the term “healthcare facility” includes an ASC. The proclamation additionally waives the provisions under WAC 246-310-020(1) subparagraphs a, b, c, e and g, which pertain to the same requirements addressed in the waived sections of RCW 70.38.105(4). According to the proclamation, “these waivers and suspensions do not apply except to temporary increases in bed capacity and projects undertaken to provide surge capacity for the COVID-19 response, for which certificates of need must be obtained after the expiration of this waiver in compliance with the waived statutory and regulatory provisions.”