K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
The Puerto Rico Secretary of Health issued Administrative Order No. 2024-589, declaring a public health emergency due to the prevalence of cases of dengue fever on the Island. Administrative Order No. 2024-589, signed on...more
On May 5, 2023, the World Health Organization declared an end to the global health emergency caused by the SARS-CoV-2 virus, known as COVID-19. While the emergency has, in many ways, waned, the virus and the need for COVID-19...more
The end of an era looms for employee benefits plans, as the Biden administration has announced the end of both the Public Health Emergency and the National Emergency periods on May 11, 2023. The two emergency periods were...more
As employers plan for the impact of the anticipated May 11, 2023, end of the two federal COVID-19 emergency orders, they have some important new clarity on test and vaccine coverage and on how to unwind COVID-19–era extended...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
Meta description: With the federal public health emergency (PHE) ending in May, changes to telehealth prescription rules are set to change. Read on to learn about proposed permanent changes. DEA Proposes Rules for...more
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
On April 12, 2022, Department of Health and Human Services (HHS) Secretary Xavier Becerra again renewed the declaration of a Public Health Emergency (PHE) under the Public Health Service Act, averting an April 16, 2022...more
April 14, 2022 On April 12, 2022, Secretary Becerra of the U.S. Department of Health and Human Services extended the existing public health emergency for 90 days, effective April 16, 2022, until July 15, 2022...more
On Monday, February 7, 2022, U.S. Senators Catherine Cortez Masto, D-Nevada, and Todd Young, R-Indiana, introduced the Telehealth Extension and Evaluation Act, which if passed, would extend several of the telehealth waivers...more
Nearly two years after declaring a public health emergency exists due to the COVID-19 pandemic, the U.S. Department of Health and Human Services (“HHS”) has extended that determination yet again. On January 14, 2022, U.S....more
The pandemic may be waning, but the requirement for Colorado employers to provide supplemental public health emergency leave to employees under certain COVID-19–related circumstances continues. On October 15, 2021, U.S....more
On July 19, 2021, Secretary Becerra of the U.S. Department of Health and Human Services extended the existing public health emergency for 90 days, until October 20, 2021. Without this extension, the declaration would have...more
On July 19, 2021, the Secretary of Health and Human Services (HHS) renewed the declaration of the COVID-19 Public Health Emergency (PHE), effective July 20, 2021. With this renewal, unless otherwise specified, any existing...more
Emergency Use Authorizations will play a role as the pandemic eases, but a transition to ordinary course approvals is underway. As long as the COVID-related emergency is deemed to exist, fast-tracked FDA regulatory...more
The one-year deadline for nursing home residents on Medicaid to spend down their first round of stimulus checks is here, but they may have a little extra time. In March 2020, the Coronavirus Aid, Relief, and Economic...more
On January 7, 2021, Secretary Azar of the U.S. Department of Health and Human Services extended the existing public health emergency for 90 days, until April 21, 2021. Without this extension, the declaration would have...more
The Centers for Medicare and Medicaid Services (CMS) just released its 2021 Final Rule (Physician Fee Schedule), with telehealth policy changes and a list of new services covered under Medicare. Actions taken by CMS during...more
In Washington: The Center for Disease Control and Prevention (CDC) is finalizing new guidelines to shorten its recommended coronavirus quarantine period from 14 days to between 7 and 10 days. The agency hopes more people...more
As COVID-19 infection rates continue to rise in areas of the country, telehealth continues to play an important role in the delivery of healthcare, especially to those most vulnerable to the virus. The Public Health...more
On October 2, 2020, Health and Human Services (HHS) Secretary, Alex M. Azar II, announced the renewal of the public health emergency declaration due to the continued consequences of the COVID-19 pandemic. The 90-day renewal...more
On August 3, 2020, President Trump signed Executive Order 13941 (the “Executive Order”) which expands access to certain telehealth services post-pandemic. The Executive Order focuses on telehealth access for individuals...more
In an announcement welcomed by many healthcare providers, on July 23, 2020, the US Department of Health and Human Services announced that the COVID-19 public health emergency would be extended 90 days, through October 23,...more
Much to the relief of the healthcare provider community, US Department of Health and Human Services (HHS) spokesperson Michael Caputo tweeted on Monday that HHS intended to extend the public health emergency that was declared...more
Prompted by a substantial increase in requests for individual patient access to investigational drugs and biologics to treat COVID-19, the U.S. Food & Drug Administration (“FDA”) issued guidance on June 2, 2020 that outlines...more