For more information about this blog post, please contact Khaled J. Klele, Ryan M. Magee, Labinot Alexander Berlajolli, or Daniel J. Parziale.
Deadline
for Phase 2 Financial Relief Applications Extended by CMS
Healthcare providers now have
more time to apply for the next round of emergency financial relief under the
Coronavirus, Aid, Relief, and Economic Security Act (the “CARES Act”). Previously,
the deadline to apply for the Phase 2 General Distribution was August 28,
2020. However, on August 25, 2020, the Centers for Medicare & Medicaid
Services (“CMS”) issued new guidance extending
the deadline to September 13, 2020 and expanding the eligible providers.
CDC
Waives Testing Recommendation for People Without COVID-19 Symptoms
The Centers for Disease Control
and Prevention (“CDC”) has updated its COVID‑19
testing guidelines, such that people without symptoms do not always need to be
tested. Previously, the CDC recommended testing for all close contacts of
COVID-19 patients. Now, close contacts no longer need a test if they do not
exhibit symptoms. Vulnerable populations can be excepted, and testing for
asymptomatic people is appropriate if recommended by clinicians or public
health officials.
Federal Action Regarding Nursing Homes
CMS Issues New Guidance Requiring
Mandatory COVID-19 Testing for Staff at Nursing Homes
On August 25, 2020, CMS issued new guidance requiring
nursing homes to regularly test their staff for COVID-19 and offer testing to
residents if there is an outbreak and/or if the resident begins to show
symptoms. Prior guidance only recommended, but did not enforce, mandatory
testing for staff and residents. As part of its August 25, 2020 guidance,
CMS announced it will be sending out surveyors to inspect nursing homes to
ensure they are in compliance. Those nursing homes not in compliance can face
up to four hundred dollars ($400) per day in fines. To offset the
additional financial burden that this will place on nursing homes, the CMS
advised it will allocate new funding through the CARES Act.
CMS Announces Resumption of
Routine Inspections of All Provider and Suppliers, Issues Updated Enforcement
Guidance to States, and Posts Toolkit to Assist Nursing Homes
CMS has announced that it
will resume routine inspections, onsite revisit surveys, non-immediate jeopardy
complaint surveys, and annual recertification surveys of all Medicare and
Medicaid certified providers and suppliers as soon as resources are
available. CMS also is providing guidance on resolving enforcement cases
that were previously on hold due to survey prioritization changes. Once
state surveyors ensure that facilities return back to compliance with federal
requirements for an onsite survey, the desk review policy will also temporarily
be extended to include noncompliance reviews (excluding immediate jeopardy
citations that have not been removed.)
In addition, CMS has issued
updated guidance regarding the re-prioritization of routine state survey agency
activities on Clinical Laboratory Improvement Amendments. Under the
guidance, state survey agencies are afforded flexibility and discretion to
direct resumption of survey activities based on the status of COVID-19
infections in their states.
CMS also has published updates to
the “Toolkit on State Actions to
Mitigate COVID‑19 Prevalence in Nursing Homes.” To better
assist nursing homes’ response to the pandemic, the toolkit details actions and
best practices by organizations, state governments, and U.S.
territories. The information is routinely updated and contains the most
recent information regarding how state governments and other public health
entities nationwide are working to contain the spread of COVID-19 in nursing homes.
CMS Launches Nursing Home
Training Program to Halt COVID-19 Spread
CMS has launched “CMS
Targeted COVID‑19 Training for Frontline Nursing Home Staff and Management,”
which is a national nursing home training program to assist front-line
caregivers and management prevent the spread of COVID-19. The training is
available to staff at any Medicare- and Medicaid-certified nursing home on the
CMS Quality, Safety & Education
portal. Among other things, the training provides guidance on
infection control and prevention, appropriate screening of nursing home
visitors, and the proper use of personal protective equipment. To ensure
that nursing home staff are aware of and participating in the training, CMS has
directed that Quality Improvement Organizations (“QIOs”) include the training
in their existing quality improvement action plans.
Additionally, CMS and the CDC
will also make available subject matter experts on bi‑weekly webinars from
August 27, 2020, through January 7, 2021, from 4:00-5:00pm ET, to answer
questions. To register for the Question and Answer webinars, visit the Zoom webinar registration page.
Federal Regulations on Guidance Documents
On August 20, 2020, the
Department of Health and Human Services (“HHS”) proposed a new rule
governing HHS’s release and maintenance of guidance documents. The
proposed regulations would ensure that the public receives appropriate notice
of new guidance and that HHS’s guidance does not impose obligations on
regulated parties that are not already reflected in duly enacted statutes or
regulations lawfully promulgated under them. The proposed rule, if
finalized, would apply to guidance documents issued by HHS, other than guidance
documents issued by FDA, which has its own good guidance practices regulations
in place. Among other things, the rule proposes establishing an online
guidance repository for electronic documents, imposes procedural guidelines for
HHS issuance of new guidance, and outlines procedures to petition review of
guidance guidelines. Comments are due by September 16, 2020. HHS
later corrected the proposed
rule, amending an error in the date by which HHS would be required to post the
guidance repository of guidance documents.
