But Wait, There’s More! CMS Provides Additional Regulatory Relief Through Expanded Blanket Waivers
The Centers for Medicare and Medicaid Services (CMS) issued blanket waivers under Section 1135 of the Social Security Act (Section 1135 waivers) on April 30, 2020. Fast on the heels of a more modest waiver announcement on April 22, 2020, the blanket waivers announced April 30 (the April 30 waivers) provides expanded flexibilities for almost all provider types, including long term care facilities, home health agencies and ambulatory surgery centers, and identify key relief related to telehealth made possible by the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
For background on Section 1135 waivers previously issued, see our On the Subject, here.
Long Term Care Facilities
During the Coronavirus (COVID-19) public health emergency (PHE), long term care facilities (LTCFs) may streamline their quality assurance and performance improvement (QAPI) plans to focus on adverse events and infection control. In addition, the response time in which an LTCF must provide records to requestors has been extended from two working days to 10 working days. The deadline for nurse aide in-service training, which normally requires 12 hours of training per year, has been postponed for the duration of the PHE and through the end of the first full quarter after the PHE ends. The April 30 waivers also provide a limited waiver of one component of LTCF discharge planning, to permit LTCFs to simplify the information provided to residents before discharge to a post-acute care provider.
Home Health and Hospice
Similar to the waivers applicable to LTCFs, home health agencies (HHAs) are permitted by the April 30 waivers to postpone the completion of home health aide training for the duration of the PHE and through the end of the first full quarter after the PHE ends. Discharge planning requirements are also similarly waived, such that HHAs need not provide detailed data on potential post-acute providers as part of the discharge planning process. Record requests may also be fulfilled in a longer time period, 10 days, rather than the usual four-day expected response time.
Hospice providers may delay completion of certain annual skills and competency training for all individuals furnishing care as well as in-service training and education programs until the end of the first quarter after the PHE ends. Importantly, the April 30 waivers do not waive all training and competency requirements, and providers are cautioned to ensure that required training under 42 CFR Part 418 continues to the extent not waived.
For HHAs and hospice providers, the requirement for home health aides to have an annual onsite supervisory visit by a registered nurse or other skilled professional has been relaxed, and such visits must now be completed no later than 60 days after the PHE has concluded. In addition, QAPI programs may be limited during the PHE to concentrate on infection control and adverse events.
Ambulatory Surgery Centers
Similar to previously announced Section 1135 waivers applicable to hospitals, the April 30 waivers provide that ambulatory surgery centers (ASCs) may permit physicians whose privileges expire during the PHE to continue to practice without the completion of a reappraisal process, permitting ASCs access to a full workforce during the emergency.
Community Mental Health Centers
Community mental health centers (CMHCs) may operate under new flexibilities announced in the April 30 waivers. The April 30 waivers provide that CMHCs may provide certain services in individuals’ homes to further efforts to shelter in place as part of the community infection control measures taken in response to the pandemic. This waiver is linked to the recently released interim final rule (IFR) that permits billing for certain services rendered to individuals in their homes. Non-waived requirements must still be met, including the requirement of physician certification of need for partial hospitalization services, the required implementation and development of an active treatment plan for each individual served, and continued promotion of patient rights (including the rights to file a complaint).
In addition, CMS has waived the “40% rule” which would otherwise require CMHCs to provide at least 40% of its items and services to individuals who are not Medicare beneficiaries, to expand the scope of available mental health services during the PHE. Finally, while CMHCs are expected to maintain a robust QAPI program, the detailed requirements related to the program’s organization and content are waived for the duration of the PHE to permit the program to adapt to the needs and circumstances that arise during the PHE, so long as the changes are consistent with the emergency preparedness or pandemic plan in the CMHC’s state of operation.
Physical Environment Waiver
The April 30 waivers include a common waiver of a physical environment requirement regarding inspection, testing and maintenance (ITM) of equipment that is otherwise applicable to hospitals (including critical access hospitals), inpatient hospice, skilled nursing facilities, nursing facilities and certain enrolled facilities for individuals with disabilities. The waiver permits ITM frequencies and activities to be adjusted due to the exigencies presented by the PHE.
However, certain ITM are exempt from the waiver, meaning that they must continue to be completed in accordance with existing requirements. ITM not waived include sprinkler system testing, monthly fire extinguisher inspection, elevator/firefighter monthly testing, emergency generator and transfer switch testing, and egress inspection to ensure use of interim egress routes in case of emergency.
While granted as part of the CARES Act legislation that broadens the existing Section 1135 waiver process, CMS announced greater flexibilities related to telehealth and included them in public-facing materials regarding the April 30 waivers.
The new waivers permit any Medicare-enrolled provider that is eligible to bill Medicare for professional services to also furnish and bill for Medicare telehealth services, dramatically expanding the availability of telehealth reimbursement to professionals, including physical and occupational therapists, speech language pathologists and others.
CMS previously announced that Medicare would pay for certain telephone evaluation and management (E/M) services. In the interim final rule with comment period released in pre-publication form on April 30, 2020 (the IFC), CMS is increasing payments for these services consistent with payments for similar office/outpatient visits. The payment increases for these services are retroactive to March 1, 2020. CMS is also adding these services to the Medicare telehealth list. Because services on the Medicare telehealth list are otherwise required to be furnished using both audio and video, CMS is waiving requirements that these telephone E/M codes be provided using video. The IFC also expands flexibilities for opioid treatment programs (OTPs). Previously, CMS had allowed certain OTP therapy and counseling sessions to be furnished via audio-only telephone calls. Under the IFC, OTPs are also permitted to furnish periodic assessments using audio-only telephone calls rather than via two-way interactive audio-video communication technology.
In conjunction with release of the IFC, CMS published an updated Medicare telehealth list, which reflects the addition of 46 services, bringing the total number of Medicare telehealth services to 239. Of these 239 services, 89 are also designated as requiring audio-only interaction. Many of the services designated as requiring audio-only interaction are behavioral health and patient education services.
The April 30 waivers continue to expand opportunities for a range of enrolled providers to operate as efficiently as possible during the PHE. As set forth in the waivers, and as detailed in the IFC, the government has taken the needs of providers into consideration as it continues to roll out these changes to participation and payment requirements. As CMS continues to respond to the COVID-19 pandemic with additional and expanded regulatory flexibilities, and as providers race to provide care under these flexibilities, keeping track of the waivers under which the provider elects to operate becomes increasingly important. The ability to recognize and document changes in operations, and to be prepared to scale them back once the emergency has concluded, will become more challenging as additional requirements are waived and providers get comfortable operating in a more flexible environment.