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.