Latest Federal Guidance and Releases in Response to COVID-19

The federal government continues to take aggressive and proactive steps to address the COVID-19 threat as the health and safety of the American people remain a top priority. Please see below for the latest guidance and releases in response to COVID-19.

Secretary Azar Announces Historic Expansion of Telehealth Access to Combat COVID-19: On Tuesday, the Trump Administration and HHS announced unprecedented steps to expand Americans’ access to telehealth services during the COVID-19 outbreak. The Centers for Medicare & and Medicaid Services (CMS) expanded Medicare coverage for telehealth visits, the HHS Office for Civil Rights (OCR) announced it will waive potential HIPAA penalties for good faith use of telehealth during the emergency, and the HHS Office of Inspector General (OIG) provided flexibility for healthcare providers to reduce or waive beneficiary cost-sharing for telehealth visits paid by federal healthcare programs. For more information see links to the CMS press release, OCR Guidance, and OIG Policy Statement.

FDA Expands Testing Capabilities: On Monday night, FDA Commissioner Hahn announced that states can set up their own system in which they take responsibility for authorizing such tests and the laboratories will not need to engage with the FDA to conduct COVID-19 testing. The updated guidance also expands the types of labs that can conduct testing and provides recommendations for test developers who are interested in developing a test. The FDA has established 1-888-INFO-FDA, to help labs with any questions they may have about the Emergency Use Authorization process, FDA policies or getting supplies. Similar to approving Roche testing last week, yesterday, the FDA also issued Emergency Use Authorizations (EUAs) to Hologic and LabCorp for their tests.

CMS Guidance for States to Apply for a Section 1135 Emergency Waiver: CMS has provided guidance for states on how to apply for a Section 1135 waiver through the Medicaid Disaster Response Tool Kit. A factsheet was released that outlines the flexibilities for healthcare providers to combat and contain COVID-19. CMS will soon provide checklists and tools to further expedite requests and approvals for waivers and other commonly requested flexibilities. Yesterday, Florida was the first state to apply for and receive approval for an 1135 waiver.

Restrictions on Gatherings: On Monday, the White House Task Force released updated guidance with a 15 day strategy to slow the spread of COVID-19 that recommends restricting gathers to 10 people or less.

CMS Nursing Home Guidance: On Friday, CMS released updated nursing home guidance that further protects nursing home residents by restricting all visitors to nursing homes except in cases of end-of-life care. The memo can be found here.

Guidance for Discontinuation of Home Isolation for Persons with COVID-19: CDC released new guidance with strategies to discontinue home isolation with options including both a time-since-illness-onset and time-since-recovery (non-test-based) strategy as well as a test-based strategy. This guidance will assist healthcare providers and public health officials managing people with COVID-19 under home isolation. Information can be found here.

Considerations in the Investigation of Cases and Clusters of COVID-19: The World Health Organization released interim guidance on Friday that includes operational guidance to for the rapid investigation of suspected COVID-19 cases after an alert or signal. It is to be used by local, regional, or national health authorities as considerations for investigating cases of COVID-19.

Regulatory Relief for Commercial Vehicles Delivering COVID-19 Supplies: On Friday, the Federal Motor Carrier Safety Administration issued an Emergency Declaration that provides regulatory relief for vehicles that are transporting medical supplies and equipment to support emergency relief efforts.