CMS Issues Second Round of Blanket Regulatory Waivers

On April 30, 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued a second round of Blanket Regulatory Waivers in response to the coronavirus (“COVID-19”) public health emergency, adding to those previously issued on March 30 (and summarized in our earlier alert) and April 10.  As with its March 30, 2020 waivers, CMS has issued the second round of waivers pursuant to its authority under Sections 1135 and 1812(f) of the Social Security Act. 

This latest round of waivers is effective immediately, has a retroactive effective date of March 1, 2020 and, as with the first round of waivers, will be in effect through the end of the Secretary of DHHS’s emergency declaration.  Providers and states also need not apply specifically for these new CMS regulatory waivers and other rule changes.

The new CMS waivers aim to accomplish five main goals: (1) to support and expand COVID-19 diagnostic testing for Medicare and Medicaid beneficiaries; (2) to increase the capacity of hospitals and other healthcare systems; (3) to expand the healthcare workforce; (4) to decrease administrative burdens imposed on healthcare providers, facilities, and states; and (5) to expand telehealth services for Medicare beneficiaries. 

The waivers, which we will summarize in greater detail in subsequent client alerts, broadly provide for the following changes:

1. Expands COVID-19 diagnostic testing for Medicare and Medicaid beneficiaries

The new CMS waivers and other rule changes no longer require a Medicare beneficiary to obtain an order from a healthcare practitioner in order to receive COVID-19 diagnostic tests and related laboratory tests.  In addition, Medicare and Medicaid will now cover “certain serology (antibody) tests” and “laboratory processing of certain FDA-authorized tests” that beneficiaries self-collect at home. 

2. Increases the capacity of hospitals and other healthcare systems

Under its “Hospitals Without Walls” initiative, CMS now allows hospitals to provide services in other healthcare facilities and sites that are not part of the existing hospital, and to set up temporary expansion sites, to increase hospitals’ capacity and ability to address patient demand.  In the past, hospitals were required to provide services within their existing departments. 

CMS has further implemented other changes designed to ensure that any payment considerations by healthcare facilities do not impede the ability to provide patient care.  For instance, CMS now gives providers the flexibility to increase the number of beds for COVID-19 patients without jeopardizing those providers’ Medicare payments.  CMS is also highlighting its payments for certain outpatient hospital services that are rendered at temporary expansion sites such as parking lots.  Those outpatient services include, but are not limited to, wound care, drug administration, and behavioral health services.

3. Expands the size and scope of the existing healthcare workforce

CMS aims to remove barriers to entry to enable more practitioners to be hired and retained to provide much-needed healthcare services.  Under the CARES Act, nurse practitioners, clinical nurse specialists, and physician assistants were authorized to provide home health services.  Under CMS’s new rule changes, those same practitioners can now, among other things, also certify the beneficiary is eligible for home health services and order such services to be provided.  Whereas Medicare and Medicaid home health beneficiaries previously needed a physician’s certificate to receive such services, a certificate is no longer required.

In addition, consistent with its goal of increasing the size of the healthcare workforce, CMS has announced that it will neither decrease Medicare payments to teaching hospitals that shift their residents to other hospitals to meet COVID-19 demands nor penalize other hospitals for accepting those residents.  Ambulatory surgery centers, similar to a change made for hospitals, also no longer need to reassess periodically the privileges of their medical staff for the duration of the public health emergency declaration.

4. Decreases administrative burdens

CMS is giving providers, healthcare facilities, Medicare Advantage and Part D plans, and states temporary relief from many reporting and audit requirements so that those individuals and entities can focus on providing healthcare services.

5. Expands telehealth services for Medicare beneficiaries

CMS is increasing Medicare patients’ ability to access health services from home by expanding its range of covered telehealth services.  For the duration of the public health emergency declaration, CMS has waived restrictions on the type of practitioners who are permitted to provide Medicare telehealth services.  Previously, only doctors, nurse practitioners, physician assistants, and certain others were permitted to engage in telehealth services.  As a result of CMS’s temporary waiver, physical therapists, occupational therapists, and speech language pathologists may now also provide reimbursable telehealth services.  In addition, CMS has waived video requirements for certain telehealth services and now allows those services to be rendered by audio-only telephone. 

As a result of CMS’s waivers and rule changes, hospitals may now bill for certain remote services provided by their hospital-based practitioners to Medicare patients who are registered as hospital outpatients.  Those remote services include counseling, educational, and therapy services.

Last, these changes to existing law and regulation have far-reaching implications for fraud and abuse risk.  As important, these changes are temporary.  How providers handle the operational implementation of these waivers (including the interpretation of the scope of each waiver) and service expansions could have regulatory enforcement implications once the Secretary declares the end of the public health emergency.  Providers should keep in mind that federal regulators are already ramping up resources for the retrospective scrutiny of how entities have operated and managed federal COVID-19 response funds.

Please note, we will be completing separate and more comprehensive summaries on specific CMS waiver issues and rule changes in the future as more information becomes available.

We note that government orders on the local, state, and federal level are changing every day, and the information contained herein is accurate only as of the date set forth above.

All entities should consult legal counsel for compliance issues and questions related to rapidly evolving COVID-19 legislation and policy. 

For any questions regarding these regulatory waivers, please contact the Winston partners listed below or your Winston relationship attorney. View all of our COVID-19 perspectives here.  Contact a member of our COVID-19 Legal Task Force here.