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HIPAA Enforcement Discretion Ends When Public Health Emergency Expires on May 11

The Department of Health and Human Services’ Office for Civil Rights (OCR) announced the expiration of its enforcement discretion related to compliance with the Health Insurance Portability and Accountability Act of 1996...more

Arizona Passes Broad Telehealth Law With Audio-Only Coverage

In response to the COVID-19 public health emergency (PHE), many states expanded access to healthcare via telehealth through regulatory waivers. Experts have speculated how governments will regulate and reimburse telehealth...more

Cyber-Insurance Considerations for Healthcare Providers Related to Ransomware Attacks

On May 7, 2021, the operator of a major pipeline system that transports fuel across the East Coast fell victim to a ransomware attack that resulted in a six-day shutdown. Over the following week, East Coast stockpiles of...more

HHS Expands HIPAA Enforcement Discretion During COVID-19

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has issued further notifications of enforcement discretion related to compliance with the Health Insurance Portability and Accountability Act of...more

COVID-19: Consolidated Medicare Telehealth Expansion Update

On March 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFC). This alert is part of a series of alerts discussing the IFC provisions and comprehensive actions...more

CMS Grants ESRD Facilities More Flexibility, Waives Certain Conditions For Coverage During COVID-19

On March 28, 2020, the Centers for Medicare & Medicaid Services (CMS) announced it was providing additional flexibility to end-stage renal disease (ESRD) facilities under the Medicare conditions for coverage at 42 CFR §§...more

CMS Announces Enforcement Discretion for Late Open Payments Reporting Due to COVID-19

On March 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an Open Payments Program COVID-19 announcement and released an updated comprehensive list of frequently asked questions about the Open Payments...more

FDA Waives Premarket Notification Requirements for Ventilator Manufacturers, Solicits Manufacturers for Ventilator Support Devices...

On March 22, 2020, the U.S. Food and Drug Administration (FDA) published guidance that relieves manufacturers of FDA-cleared ventilator products of the requirement to submit a premarket notification (510(k)) prior to making...more

10 Key Points From CMS’ Guidance to Dialysis Facilities Regarding COVID-19

On March 10, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Dialysis Facilities. This guidance addresses practices...more

HHS Limited Waiver and Guidance on HIPAA and the Privacy Rule During COVID-19 Pandemic

Since the outbreak of COVID-19, the Department of Health and Human Services Office for Civil Rights (OCR) has issued various guidance documents on compliance with the Health Insurance Portability and Accountability Act of...more

Revised Families First Coronavirus Response Act Becomes Law — Five Things Healthcare Providers Need to Know

On March 16, 2020, the U.S. House of Representatives unanimously passed corrections to the Families First Coronavirus Response Act (H.R. 6201), which was originally passed by the House on March 14, 2020. On March 19, the...more

HHS Acts to Support Telehealth Services in Response to COVID-19: Six Key Takeaways

The unprecedented public health emergency created by the coronavirus disease (COVID-19) has sparked action by the U.S. government to ensure greater access to healthcare via telehealth services, especially for high-risk...more

House Passes Families First Coronavirus Response Act – Five Things Healthcare Providers Need to Know

On March 14, 2020, the U.S. House of Representatives voted 363 to 40 (with one representative voting present) to pass H.R. 6201 – Families First Coronavirus Response Act. The bipartisan legislation, negotiated between House...more

CMS Responds to COVID-19 National Emergency Declaration

On March 13, 2020, the Trump administration announced a series of waivers and regulatory flexibilities designed to help healthcare providers and states in responding to and containing the spread of the 2019 novel coronavirus...more

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