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HHS Announces Medicaid and Medicare Flexibilities, Investigations post-Change Healthcare Cyberattack

Since becoming aware of the cyberattack on Change Healthcare in late February, the Centers for Medicare & Medicaid Services (CMS) has announced a number of flexibilities to support affected providers that have experienced...more

Upcoming Regulatory Changes Associated With the End of the PHE

At 11:59 p.m. on Thursday, May 11, 2023, the COVID-19 public health emergency (PHE) declaration will conclude, more than three years after taking effect in January 2020. The PHE declaration has enabled the U.S. Department of...more

District Court Blocks ACA Provision Mandating Coverage of Preventive Services

The Affordable Care Act (ACA) requirement for commercial coverage of certain preventive services without cost sharing is unenforceable, according to a March 30 decision in Braidwood Management, Inc. v. Becerra by Judge Reed...more

What Changes if the COVID-19 Public Health Emergency Ends May 11

The Biden Administration has announced that May 11, 2023, will be the final day of the COVID-19 public health emergency (PHE) declaration, which has been in effect since January 2020. Following the White House’s announcement...more

Biden Administration Proposes Substantial Revisions to Health Care Nondiscrimination Rules

The Big Picture - On July 25, the Department of Health and Human Services (HHS) released a proposed rule interpreting Section 1557 of the Affordable Care Act (ACA), which prohibits any health program or activity that...more

HHS Renews COVID-19 Public Health Emergency Through July 19, 2021; Additional Renewals Are Expected

On April 15, 2021, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID‑19 will be renewed for another 90 days, beginning on April 21 (the date the PHE...more

PREP Act Declaration Authorizes COVID-19 Vaccine Administration by Most Health Care Practitioners

On March 11, the U.S. Department of Health & Human Services (HHS) released its latest declaration under the Public Readiness and Emergency Preparedness (PREP) Act. Building on prior declarations, this latest amendment...more

HHS Finalizes Automatic SUNSET Dates and Mandatory Reassessment Requirements for Most Regulations

The Big Picture - On January 8, the U.S. Department of Health & Human Services (HHS) released a final rule that imposes a ten-year sunset date on most regulations that have ever been, or will ever be, issued by HHS and...more

[Webinar] Unpacking the Anti-Kickback and Stark Reforms: Promoting Value-Based Care and Easing Regulatory Compliance - January...

A New Manatt Webinar Guides You Through New Reforms Promoting Value-Based Care and Easing Regulatory Compliance—the Most Significant Changes to the Federal Fraud and Abuse Landscape in the Last Decade. On November 20,...more

New HHS Regulations Create Opportunities for Digital Health Partnerships

On November 20, 2020, the Department of Health and Human Services (HHS) finalized a set of sweeping changes to the regulatory framework that governs fraud and abuse in the Medicare and Medicaid programs. Among other changes,...more

HHS Finalizes Anti-Kickback and Stark Reforms that Simplify Compliance and Promote Value-Based Care

On November 20, 2020, the Department of Health and Human Services (HHS) published two rules that finalize sweeping reforms to the regulations governing fraud and abuse in the Medicare and Medicaid programs. The first rule,...more

COVID-19 Vaccine Distribution: Key Challenges and Outstanding Questions

On September 16, 2020, the Trump Administration issued, for the first time, a planning framework for allocation and distribution of an eventual COVID-19 vaccine (the Federal Distribution Strategy). After briefly summarizing...more

CMS Guidance Authorizes Medicaid Demonstration Applications That Cap Federal Funding: Implications for States - Prepared with...

On January 30, the Department of Health and Human Services (HHS) released long-anticipated guidance that invites states to pursue capped funding demonstrations for the Affordable Care Act Medicaid expansion population as well...more

HHS Proposes New Anti-Kickback and Stark Protections for Value-Based Care

In October 2019, the Department of Health & Human Services (HHS) released two rules that propose sweeping reforms to the regulations governing fraud and abuse in federal healthcare programs, including Medicare and Medicaid....more

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