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President Biden declares monkeypox a public health emergency

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By Yvonne Puig (US) & Daphne Calderon (US) on August 5, 2022

The US is approaching 7,000 cases, the largest number of any country around the world. Of concern to the Administration is the nearly 80 percent increase in cases over the last 7 days. Of equal concern is the lack of…

COVID-19 Update – HHS OCR Releases Legal Guidance for Expanding Vaccine Access to People with Disabilities and Older Adults

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By Yvonne Puig (US), Daphne Calderon (US) & Jeff Wurzburg (US) on April 14, 2021

On April 13, 2021, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) published a press release with resources, including from the Administration for Community Living (“ACL”) and the Office of the Assistant Secretary for Planning…

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COVID-19 Update: CDC Increasing Sequencing for Virus Variants

Photo of Yvonne Puig (US)Photo of Daphne Calderon (US)Photo of Jeff Wurzburg (US)
By Yvonne Puig (US), Daphne Calderon (US) & Jeff Wurzburg (US) on February 26, 2021

The Biden Administration recently announced additional funding to increase genomic sequencing of COVID-19 to 25,000 samples a week.  In a recent article in the Journal for the American Medical Association, U.S. Centers for Disease Control and Prevention (“CDC”)…

HHS Issues Final Rule Requiring Retrospective Review of Regulations

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By Mark Faccenda (US), Jeff Wurzburg (US) & Hayley White (US) on January 11, 2021

On Friday, January 8, 2021, the Department of Health and Human Services (“HHS”) released a final rule that would provide HHS with five years to review existing regulations that are more than ten years old, subject to certain exceptions, to…

CMS Publishes 2021 Hospital OPPS and ASC Final Rule

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By Jeff Wurzburg (US) on December 4, 2020

The Centers for Medicare & Medicaid Services (“CMS”) has published the Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgery Center (“ASC”) final rule for CY 2021.  CMS finalized an annual increase OPPS and ASC rates of 2.4 percent for…

Healthcare Regulatory Landscape Transformed by Stark, AKS Final Rules

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By Jeff Wurzburg (US) on November 23, 2020

In what may prove to be the most substantial fraud and abuse rulemaking in over a decade, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) published on…

COVID-19 Update: CMS Releases Fourth COVID-19 Interim Final Rule with Comment Period

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By Mark Faccenda (US), Jeff Wurzburg (US) & Hayley White (US) on November 4, 2020

On Wednesday, October 28, 2020, the Centers for Medicare & Medicaid Services (“CMS”), with the Departments of Treasury and Labor, issued a fourth interim final rule (“IFR”) with comment period addressing the public health emergency (“PHE”). The policies in the…

COVID-19 Update: HHS Renews COVID-19 Public Health Emergency Declaration

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By Mark Faccenda (US), Jeff Wurzburg (US) & Hayley White (US) on October 12, 2020

On October 2, 2020, Secretary Azar of the Department of Health and Human Services (“HHS”) renewed his public health emergency (“PHE”) declaration because of “the continued consequences” of the COVID-19 pandemic.

This renewal will become effective on October 23, 2020…

HHS Issues Proposed Rule on Good Guidance Practices

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By Jeff Wurzburg (US) & Hayley White (US) on August 25, 2020

On August 20, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule that would impose requirements regarding the issuance and reliance on HHS guidance documents. This proposed rule results from the 2019 U.S. Supreme Court…

Court of Appeals upholds 340B Reductions

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By Mark Faccenda (US) & Jeff Wurzburg (US) on August 4, 2020

On Friday July 31, 2020 the U.S. Circuit Court of Appeals for the District of Columbia Circuit reversed the federal district court and permitted reimbursement cuts for drugs purchased through the 340B Drug Discount Program.…

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