The California Department of Public Health (“CDPH”) announced in an All Facilities Letter March 26 that it is temporarily waiving certain licensing requirements and suspending enforcement of select regulations for Primary Care Clinics (“PCCs,” licensed according to Health and Safety Code section 1200) and Mobile Health Care Units (“MHCUs,” licensed according to Health and Safety Code section 1765.105). The suspensions are pursuant to the Governor’s Executive Order N-35-20, issued on March 21, 2020, which gave the Director of CDPH authority to waive licensing and staffing requirements for clinics, adult day health cares, hospices, or mobile health care units. Under the All Facilities Letter, the waiver is valid until June 30, 2020.
The waiver is conditioned on PCCs and MHCUs (1) reporting all substantial staffing or supply shortages that disrupt operations or jeopardize patient care; (2) following their disaster response plans; (3) following CMS and CDC COVID-19 infection control guidelines; and (4) complying with local public health department directives to the extent the directives are not in conflict with federal or state law or CDPH All Facilities Letters.
The suspensions of PCC requirements announced in this All Facilities Letter also apply to MHCUs operated by PCCs. MHCUs operated by General Acute Care Hospitals (“GACHs”) are subject to the suspensions of GACH requirements specified in CDPH’s March 20 All Facilities Letter.
Temporary Changes to Regulations
PCC Regulation Changes
CDPH is waiving a variety of regulatory requirements and restrictions on PCCs to facilitate a robust response to COVID-19. One major change is the suspension of the limit restricting intermittent clinics to operating no more than 40 hours per week. Other testing and reporting requirements have also been suspended, including tuberculosis testing at time of employment, reporting changes to principle officers or administrators within 30 days, and reporting patient records arrangements within 5 days of closure of a PCC ceasing to operate.
Changes have also been made to enable PCCs to easily convert space for patient care and triage. PCCs may convert space without prior approval from CDPH, so long as implementation both ensures safe and adequate patient care and follows recommended COVID-19 mitigation strategies.
MHCU Regulation Changes
CDPH is waiving two areas of regulation related to MHCUs. First, the requirement that an MHCU have a transfer agreement with a nearby hospital or health facility is suspended. Second, MHCUs operated by general acute care hospitals are now allowed to provide basic hospital services.
Temporary Changes to Licensing
Both initial applications and renewal applications are affected by CDPH’s waivers. For new applications, CDPH is allowing PCCs that have submitted the following applications to begin providing care prior to approval and licensure by the department:
- Initial licensure;
- Adding of services, both special services and services that are not special services;
- Remodel or modification; and
- Adding an additional facility on a separate premises.
The 60-day prior notice requirement for changing a service, remodeling, modifying, or adding an additional facility has also been suspended. Additionally, clinic corporations applying for PCC initial licensure as an affiliate clinic at an additional site may now begin providing care before approval and licensure has been granted.
In addition to the waivers for new applications, PCCs that have submitted the following renewal applications may continue providing care prior to approval and licensure by CDPH:
- License renewal;
- Special permit renewal;
- License restatement for a voluntarily and temporarily suspended license; and
- Special permit reinstatement for a voluntarily and temporarily suspended special permit.
MHCU applicants with the following applications may provide care prior to approval and licensure by CDPH:
- Initial licensure;
- Addition on an MHCU to an existing license; and
- Modifications to an MHCU’s previously approved services and procedures or to the unit itself.
Questions
If you have any questions regarding this Legal Alert, please contact the following from our office, or the attorney with whom you normally consult.
Jennifer Scott
jscott@kmtg.com | 916-321-4349