News & Analysis as of

Health Insurance Portability and Accountability Act (HIPAA) Waivers

McAfee & Taft

Employer health plan surcharges pose litigation risks

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Many employers implement wellness programs into their employee health plan offering. Wellness programs have varying designs but commonly offer premium discounts to participants who are tobacco-free or achieve certain...more

Baker Donelson

Temporary Regulatory Relief for South Carolina Health Care Providers Responding to Hurricane Helene

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South Carolina Governor Henry McMaster declared a State of Emergency on September 25, 2024, to prepare for Hurricane Helene. On September 29, 2024, the Federal Emergency Management Agency (FEMA) issued a Federal Major...more

BakerHostetler

Healthcare Technology Regulatory Update - March 2024

BakerHostetler on

Federal and state agencies continue to remain active this year, particularly with regard to laws that impact healthcare technology. As part of our ongoing efforts to track health technology-related legislation and...more

King & Spalding

FDA Issues Final Rule Permitting IRB Waiver or Alteration of Informed Consent for Certain Minimal Risk Clinical Investigations

King & Spalding on

The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more

Morgan Lewis - Health Law Scan

Back to Business: Adapting to the Expiration of 4 HIPAA Enforcement Discretion Waivers

Throughout the COVID-19 pandemic and related public health emergency (PHE), the US Department of Health and Human Services, Office for Civil Rights (OCR) issued four Notifications of Enforcement Discretion (referred to as...more

Harris Beach Murtha PLLC

The End of the Public Health Emergency is Near

President Biden announced that the COVID-19 national emergency and public health emergency (PHE) will expire on May 11, 2023. During the PHE, federal agencies were permitted to grant blanket waivers for certain health care...more

Sheppard Mullin Richter & Hampton LLP

Tracking the Waivers: Implications of the Wind Down of the COVID-19 Public Health Emergency

The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...more

Ankura

COVID-19 Public Health Emergency – Compliance Considerations as We Prepare for the End of the PHE

Ankura on

On January 30, 2023, the Biden Administration announced plans to end the Public Health Emergency (PHE) on May 11, 2023. The PHE was enacted on January 27, 2020, to provide flexibility to healthcare providers and payors...more

Venable LLP

Return to "Normalcy" - Bracing for the End of the Public Health Emergency

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In January 2020, Alex M. Azar, II, then secretary of the U.S. Department of Health and Human Services (HHS), signed a nationwide declaration of a Public Health Emergency (PHE) that would largely shape the response of public...more

King & Spalding

FDA (Finally!) Issues Proposed Rule to Amend FDA Regulations on the Protection of Human Subjects and Institutional Review Boards

King & Spalding on

The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs).1 If...more

Bass, Berry & Sims PLC

Harmonization is Here: What FDA’s Proposed Human Subject Protection Rules Mean for You

Bass, Berry & Sims PLC on

On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more

Foley & Lardner LLP

New York Ends Telehealth Waivers; Issues New Medicaid Guidance

Foley & Lardner LLP on

New York’s telehealth emergency waivers have expired, according to a June 25, 2021 announcement issued by Governor Andrew Cuomo’s Office declaring the waivers (contained in Executive Orders 202 through 202.11 and 205 through...more

Dentons

Discrimination Concerns in Skipping Notice Period

Dentons on

Last week, we looked at some of the concerns businesses face when they consider whether to let an employee work the duration of their notice period or if it’s better to cut ties quickly. Read about the issues that notice...more

Dentons

Don’t Let the Door Hit You on the Blank on the Way Out: Skipping the Notice Period

Dentons on

Every HR manager has had that moment where they’re trying to decide whether or not to waive a notice period for an employee who is terminating. Many also have a trickle of doubt about the repercussions waiving the notice...more

Foley & Lardner LLP

Top 5 Telehealth Law Predictions for 2021

Foley & Lardner LLP on

With 2020 officially behind us, what does 2021 have in store for telemedicine and digital health policy? A year ago, our team predicted 2020 would bring “notable expansions in Medicare and Medicaid coverage” and “the...more

Mintz - Health Care Viewpoints

Telehealth Update: CMS Proposed CY 2021 Payment Policies, Extension of the Public Health Emergency, Increasing Access after...

On August 4, CMS posted a proposed rule on CY 2021 Payment Policies, which included important updates about the expansion of Medicare covered telehealth services due to the COVID-19 pandemic. This follows on the heels of...more

Moritt Hock & Hamroff LLP

HHS Extends Public Health Emergency; Allows Telehealth Waivers To Continue

The Secretary of Health and Human Services announced a renewal of the nationwide public health emergency ("PHE") late on Thursday, July 23, 2020. The announcement came just two days before the then-current PHE designation was...more

Chambliss, Bahner & Stophel, P.C.

Exponential Increase in Telehealth Use – Will Waivers & Flexibilities Last?

As most are aware, the telehealth industry has experienced a major expansion during the COVID-19 pandemic. The volume of telehealth claim lines in April 2020 alone reportedly increased more than 8,000% versus April of 2019,...more

Epstein Becker & Green

Every HIPAA Waiver Has Its Thorn

On March 17, 2020, the Office for Civil Rights’ (“OCR”) announced that—for the duration of the COVID-19 emergency—it would exercise enforcement discretion and waive any potential penalties for HIPAA violations relating to...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2020 COVID-19 Essentials for Healthcare Compliance Programs - July 21st, 11:00 am CT

HCCA has assembled a half-day virtual conference to help compliance professionals stay on top of the fast-moving changes caused by the COVID-19 pandemic. By participating in this event, you will hear directly from the...more

Benesch

Updated Telehealth Summary (III): Telehealth During COVID-19 National Emergency

Benesch on

Acting under its broad authority granted under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), in an April 21, 2020 release the Centers for Medicare and Medicaid Services (“CMS”) announced an even...more

Bricker Graydon LLP

COVID-19 recovery: Legal considerations for hospitals and health systems planning for post-pandemic operations

Bricker Graydon LLP on

While health care providers continue to focus on the challenges of treating COVID-19 patients and complying with newly-issued state government "reopening" orders, now is the time to begin planning for a successful transition...more

Hinshaw & Culbertson - Health Care

Limited Suspension of HIPAA Sanctions and Penalties During National Emergency

In response to President Trump's declaration of a national emergency concerning COVID-19, the U.S. Department of Health and Human Services (HHS) has issued a limited waiver of sanctions and penalties against covered hospitals...more

Snell & Wilmer

Applications Open for $200 Million COVID-19 Telehealth Program

Snell & Wilmer on

As a follow up to our legal alert posted on April 7, 2020, the Federal Communications Commission ("FCC") announced that it is accepting applications for its $200 million COVID-19 Telehealth Program as of April 13, 2020. As a...more

Perkins Coie

FCC Adopts New Programs to Help Telehealth Services Combat COVID-19

Perkins Coie on

Update 04.10.2020: The FCC has launched an online portal explaining the application process for grants from the $200 million in funding to support telehealth services described in this client update. The FCC will begin...more

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