WSR 20-14-014
[Filed June 22, 2020, 9:22 a.m.]
I. INTRODUCTION AND PURPOSE: Washington state governor Jay Inslee has issued Proclamation 20-05, subsequently amended, proclaiming a statewide state of emergency due to an outbreak of coronavirus disease 2019 (COVID-19) in the United States and community spread of COVID-19 in Washington state.
At the federal level, the Centers for Medicare and Medicaid Services (CMS) has issued blanket 1135 waivers, with a retroactive date of March 1, 2020, through the end of President Trump's emergency declaration:
The Office for Civil Rights at the United States Department of Health and Human Services (HHS) has also issued notification that, during the COVID-19 national emergency, it will exercise enforcement discretion and will not enforce penalties for good faith compliance with Health Insurance Portability and Accountability (HIPAA) regulations connected to telehealth and participation in community-based testing sites.
II. AUTHORITY: The department of health (department) issues this guidance under its authority to interpret, administer, and enforce the provisions of chapter 70.41 RCW and the rules adopted thereunder, chapter 18.130 RCW and the rules adopted thereunder, and chapter 246-320 WAC.
III. SCOPE AND DURATION: During the time period of Governor Inslee's declared State of Emergency and to support health care providers and facilities responding to COVID-19, the department provides the following guidance to achieve alignment with CMS blanket waivers and HHS guidance referenced above for providers licensed under chapter 18.130 RCW, hospitals licensed under chapter 70.41 RCW, and other health care facilities to which the state laws below apply. This updates guidance previously filed as WSR 20-09-128 by adding Section V regarding HHS guidance related to HIPAA. This guidance applies retroactively beginning on March 1, 2020, to correspond with the effective date of the federal blanket waivers until the time period of Governor Inslee's declared State of Emergency.
Discharge Planning: CMS has waived detailed discharge planning for hospitals related to post-acute care services to allow for a more fluid transfer process and expedite the safe discharge and movement of patients among care settings. CMS has not waived the requirement that transfers are to an appropriate setting with the necessary medical information and goals of care.
The department acknowledges and supports the flexibility CMS has provided to ensure discharges are done without undue delay to respond to COVID-19. The department will likewise exercise regulatory flexibility to permit licensed hospitals to discharge patients in compliance with CMS standards, notwithstanding any inconsistent requirements in RCW 70.41.322, 70.41.324, and WAC 246-320-226. The department continues to require appropriate discharge planning and processes.
Patient Transfer Process: CMS is waiving the enforcement of section 1867(a) of the Emergency Medical Treatment and Labor Act (EMTALA) to allow facilities to screen patients at a location offsite from the hospital's campus to prevent the spread of COVID-19.
The department interprets RCW 70.170.060(2) and WAC 246-320-281 as allowing the transfer of a patient with an emergency medical condition from an emergency department to another appropriate setting of care if the transferring hospital reasonably determines that the transfer is needed to preserve limited medical resources due to the COVID-19 outbreak. A transfer may not be based on ability to pay, and the transferring hospital must follow reasonable procedures in making transfers, including confirming acceptance of the transfer by the receiving hospital. A transfer must also comply with the provisions of EMTALA that have not been waived.
Patient Care Services and Verbal Orders: Based on the department's exemption authority pursuant to WAC 246-320-026(1), the department exempts all hospitals from complying with the requirements in:
(1) WAC 246-320-226 (3)(g) to mirror the CMS exemption related to preestablished protocols to give hospitals flexibility in their use.
(2) WAC 246-320-166 (4)(h) to give flexibility in the timeline for accepting and transcribing verbal orders for the medical record consistent with the CMS waivers related to verbal orders.
Adverse Events Reporting: The Governor's Proclamation 20-36 waived the adverse event reporting timelines in RCW 70.56.020 (2)(a) and (b), which require adverse health event notification within forty-eight hours and a root cause analysis and corrective action plan to be reported within forty-five days. The department deems these timelines to also be waived in its corresponding rules, WAC 246-302-020 (1) and (2), which aligns state law with CMS's 1135 waiver of the requirement to promptly report patient deaths occurring while in restraint or seclusion.
Seclusion: CMS has provided flexibility in the use of seclusion to address potential confinement needs in responding to COVID-19. The department's rule, WAC 246-320-226 (3)(f), requires the use of seclusion to be consistent with 42 C.F.R. 482. The department deems seclusion that is consistent with the 1135 waiver to be consistent with 42 C.F.R. 482.
V. GUIDANCE TO ACHIEVE ALIGNMENT WITH HHS HIPAA GUIDANCE: The department enforces HIPAA compliance and the state's privacy laws (chapter 70.02 RCW) via the Uniform Disciplinary Act, RCW 18.130.180(7).
The department will use enforcement discretion in alignment with HHS to not penalize providers under chapter 18.130 RCW for noncompliance with the regulatory requirements under the HIPAA rules in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency. The following HHS guidance explains what applications and video communications are or are not allowed and provider responsibilities:
The department will use enforcement discretion in alignment with HHS to not penalize providers under chapter 18.130 RCW for a failure to comply with HIPAA regulations in connection with the good faith participation in the operation of a COVID-19 community based testing site. Additional guidance from HHS can be found here:
Dated: June 22, 2020.
John Wiesman, DrPH, MPH