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Keeping your dawn raid guidance current
Unannounced inspections or ‘dawn raids’ are used by antitrust authorities to obtain evidence when there are suspicions that individuals or businesses have infringed the antitrust rules.
United States | Update | March 2020
As the United States government works to quickly combat the spread of the coronavirus, healthcare providers must consider the rapidly evolving guidance while maintaining compliance with current statutory and regulatory requirements. Norton Rose Fulbright lawyers are closely monitoring these government and health organization pronouncements and counseling clients on their operations and compliance with legal requirements.
On Friday, March 13, 2020, President Trump declared the COVID-19 pandemic a national emergency, three days after the World Health Organization (WHO) classified COVID-19 as a pandemic.1 President Trump also instructed state governments to activate their emergency preparedness contingency plans. Secretary of the US Department of Health and Human Services (HHS) Alex Azar had previously declared a public health emergency on January 31, 2020.2
The emergency declaration relies on the National Emergency Act, which grants the President and executive branch sweeping power to act quickly in an emergency, including suspending or waiving provisions of federal law. President Trump also invoked the Stafford Act, which empowers the Federal Emergency Management Agency to direct the US response and assist state and local governments. The emergency declaration frees US$50 billion in federal resources to address the spread of COVID-19 and allows HHS Secretary Alex Azar to waive regulatory impediments to this response. Under Section 1135 of the Social Security Act, the Secretary may temporarily waive or modify certain Medicare, Medicaid, and CHIP requirements.3 For example, the Secretary may waive or modify conditions of participation or certification and preapproval requirements. In determining whether to invoke a 1135 waiver, the Assistant Secretary for Preparedness and Response considers requests from Governors' offices, feedback from healthcare providers, and requests to regional or field offices for assistance.4 The Centers for Medicare & Medicaid Services (CMS) may implement specific waivers or modifications on a "blanket" basis when "a determination has been made that all similarly situated providers in the emergency area need[s] such a waiver or modification."5 However, Section 1135 waiver authority applies only to federal requirements and does not apply to state requirements, for example, licensure requirements.
The emergency declaration provides the HHS Secretary with broad authority to grant waivers to give additional flexibility to providers. Specifically, under section 1135 of the Social Security Act,6 the Secretary may temporarily waive or modify certain Medicare, Medicaid and CHIP program requirements and conditions of participation. The following waivers are some of the waivers made available to healthcare providers:
CMS has been issuing guidance to providers and state survey agencies following the declaration of a public health emergency.
As CMS issues additional guidance, it may be found on the Current Emergencies website.25
The US House of Representatives, with bipartisan support, passed the Families First Coronavirus Response Act early Saturday morning, March 14, 2020.26 The Senate is expected to promptly pass the legislation during the week of March 16, 2020.
With an emphasis on testing, the bill requires private health plans to cover COVID-19 diagnostic testing, including the cost of provider, urgent care center, and emergency department visits.27 Medicare Part B, Medicare Advantage, TRICARE, Medicaid and CHIP must also cover expenses for provider visits when a COVID-19 test is administered or ordered.
The bill provides job-protected leave for government employees and employees of employers with fewer than 500 employees.28 Leave may be used for quarantine due to exposure or symptoms of COVID-19, to care for a quarantined family member, and to care for a child if the child's school or care is made unavailable due to COVID-19. The legislation also includes a refundable tax credit equal to 100 percent of paid sick and family leave wages paid by an employer.29 The tax credit applies to amounts paid to sick or quarantined employees, and a lesser credit applies to amounts paid to employees caring for family.
The bill increases the Medicaid Federal Medical Assistance Percentages (FMAP), the rate determining the amount of federal funds given to a state for Medicaid expenditures, by 6.2 percent.30 The bill also provides US$1 billion for emergency grants to states for processing and paying unemployment insurance benefits,31 and increased food aid to low income families and food assistance programs.32
Many physician associations are regularly updating guidance for clinicians. For instance, the American Medical Association and the American Academy of Family Physicians have published guidance resources for physicians addressing COVID-19.33 Various state organizations, such as the California Medical Association34 and the Pennsylvania Medical Society have designated resource centers on their website, providing guidance to both physicians and patients. In addition, the American College of Emergency Physicians and the Infectious Diseases Society of America are continually updating their COVID-19 resource centers with guidance in topic areas including clinical assessment and personnel.35
The Joint Commission is available to help accredited organizations develop appropriate COVID-19 responses, and will continue providing regular updates. The Joint Commission will continue conducting surveys in most places until it is no longer safe for employees.36
Norton Rose Fulbright attorneys are continuing to monitor government and other guidance for providers regarding this public health crisis. Please check our blog, The Health Law Pulse for regular updates.37 For updates regarding other industries, see our dedicated Coronavirus page on nortonrosefulbright.com.38
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Unannounced inspections or ‘dawn raids’ are used by antitrust authorities to obtain evidence when there are suspicions that individuals or businesses have infringed the antitrust rules.
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The EU Foreign Subsidies Regulation, or FSR, is intended to prevent or remedy distortions of the EU internal market caused by “foreign” – meaning non-EU – subsidies benefitting companies active in the EU.
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The English High Court has given its judgment in the legal battle between FW Aviation (FWA) and VietJet Aviation Joint Stock Company (VietJet). This case revolved around the enforcement of leasing agreements for four Airbus aircraft and the alleged interference by VietJet in the aircraft’s repossession in Vietnam.
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