Temporary Suspension of Certificate of Need Regulations & Facility Licensing Requirements

March 31, 2020

Elana R. Zana (ezana@omwlaw.com)

 

Governor Inslee announced in Proclamation 20-36 the immediate waiver and suspension of portions of the DOH licensing statutes and rules relating to certain health care facilities to respond to the COVID-19 pandemic.  These waivers are effective until April 29, 2020.

 

Certificate of Need

The following is a brief synopsis of the waiver of the CN review requirements. Please consult the cited, corresponding statute and Proclamation 20-36 for the full rule. The following CN review requirements are waived, in their entirety, for:

  • Construction and development of a new health care facility (RCW 70.38.105(4)(a), WAC 246-310-020(1)(a));
  • Sale, purchase or lease of an existing hospital (RCW 70.38.105(4)(b), WAC 246-310-020(1)(b));
  • Change in bed capacity which increases the total number of licensed beds, or redistributes beds among acute care, nursing home care, and assisted living facilities (RCW 70.38.105(4)(e), WAC 246-310-020(1)(c));
  • Change in bed capacity of a rural health care facility licensed under RCW 70.175.100 that increases the total number of nursing home beds, or redistributes beds from acute care or assisted living facility care to nursing home care (RCW 70.38.105(4)(e);
  • Any expenditure for the construction, renovation, or alteration of a nursing home, or change in nursing home services in excess of the expenditure minimum made in preparation for any undertaking  subject to CN review (RCW 70.38.105(4)(g), WAC 246-310-020(1)(g));
  • Any increase in the number of dialysis stations in a kidney disease center (RCW 70.38.105(4)(h), WAC 246-310-020(1)(e));

The waiver and suspension of the CN requirements are only applicable to projects used to provide surge capacity for the COVID-19 response.  Thereafter, CN approval must be obtained after the expiration of this waiver in compliance with the statutory and regulatory requirements.

The Hospice Cycle 2 and Dialysis Facility concurrent review deadlines will also be delayed by 30-days.  Following the delays, the concurrent review cycles will resume on the same regulatory review timelines but will be set back 30 days.

 

Facility Licensing Requirements

The Governor’s Proclamation also included waivers and suspensions in their entirety of many hospital licensing requirements including, but not limited to, certain patient notices, bed limitations for rural hospitals, notifications of adverse health events, duration of hospital licenses, and MRSA policies.  Included in these waivers are certain hospital licensing regulations contained in WAC 246-320. For a complete list of the relevant statutes and hospital licensing regulations, please see the Governor’s Proclamation 20-36.

 

Further, the Governor’s Proclamation eased the pharmacy assistant rules under RCW 18.64A and modified certain locational requirements for pharmacy licenses under RCW 18.64; specifically, no longer requiring that pharmacy ancillary personnel obtain authorization by the commission, and waiving the requirements of approval of the commission under RCW 18.64A.060, but retaining all other limitations and requirements contained in RCW 18.64A. This waiver also includes modifications to WAC 246-901-020, WAC 245-901-035 regarding specialized functions, and suspension of WAC 246-901-100 in its entirety.

The waiver provisions are further identified in the Governor’s Proclamation 20-36 and are only temporary in nature to provide surge capacity for COVID-19 response.  Hospitals, pharmacies and other healthcare entities must comply with the statutory and regulatory provisions after the expiration of the waiver.

For more information regarding the Certificate of Need or Licensing waivers and suspensions, please contact Elana Zana at 206-442-1308 or ezana@omwlaw.com or Don Black at dblack@omwlaw.com.