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No Surprises Act: HHS Extends Enforcement Moratorium on Co-Provider & Co-Facility Good Faith Estimates

To the relief of many providers and facilities and with just three weeks to go until the implementation date, the U.S. Department of Health & Humans Services (HHS) announced that it is extending its policy of not enforcing...more

Federal District Court Vacates QPA Rebuttable Presumption Provisions of No Surprises Act Regulations

On February 23, 2022, in the case captioned Texas Med. Ass’n v. U.S. Dep’t of Health & Human Servs., No. 6:21-cv-00425-JDK (E.D. Tex.), the U.S. District Court for the Eastern District of Texas issued the first major judicial...more

CMS Releases No Surprises Act State Enforcement Letters

During a National Stakeholder Call on January 18, 2022, Ellen Montz—Deputy Administrator and Director of the Center for Consumer Information and Insurance Oversight (CCIIO) at the Centers for Medicare and Medicaid Services...more

Podcast: No Surprises Act: New Rules and Guidance for Stakeholders (Part 2) - Diagnosing Health Care [Video]

The Biden administration has released a series of rules and guidance to implement the No Surprises Act, which went into effect on January 1. All providers and facilities must now provide a good faith estimate to uninsured and...more

Podcast: No Surprises Act: New Rules and Guidance for Stakeholders (Part 1) - Diagnosing Health Care [Video]

The No Surprises Act (NSA) will go into effect on January 1, 2022. Since our last episode on the topic, the federal government has issued additional interim final rules and guidance to implement the NSA, including the second...more

Podcast: No Surprises Act: Considerations for Plans and Providers - Diagnosing Health Care [Video]

On December 27, 2020, President Trump signed into law the No Surprises Act as part of the $2.3 billion Consolidated Appropriations Act. Recently, the Biden administration issued its first interim final rule in order to...more

The No Surprises Act: New and Surprising Challenges for Clinical Laboratories

On July 13, 2021, the U.S. Departments of Health and Human Services, Labor, and the Treasury, and the Office of Personnel Management (collectively, “Departments”) published their highly anticipated interim final rule (“First...more

The No Surprises Act: A Look at the First Round of Federal Regulations on Surprise Billing

On July 13, 2021, the Biden administration (“Administration”) officially published the “Requirements Related to Surprise Billing; Part I”—its first regulatory response to the enactment of the No Surprises Act (“NSA”)—as an...more

Will Federal or State Law Control?

When introducing the No Surprises Act (“NSA”)—signed into law on December 27, 2020, as part of the Consolidated Appropriations Act, 2021—leaders of the responsible committees of the U.S. House of Representatives announced...more

The No Surprises Act: Implications for Health Plans, Health Care Facilities, and Health Care Providers

Following months of congressional negotiations, on December 27, 2020, President Trump signed into law the Consolidated Appropriations Act, 2021, a $2.3 trillion piece of legislation that includes $900 billion in federal...more

Finalized HHS Drug Formulary Rebate Rule Faces Uncertain Future Under Biden Administration and Current Legal Challenge

On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to...more

False Claims Act Enforcement During the COVID-19 Pandemic and Beyond

Earlier this summer, Ethan P. Davis, Principal Deputy Assistant Attorney General for the Civil Division of the U.S. Department of Justice (DOJ) delivered remarks addressing DOJ’s top priorities for enforcement actions related...more

President Trump Signs Executive Orders on Drug Pricing and Domestic Supply Chain Reform

On August 6, 2020, President Donald Trump signed an executive order directing federal agencies to increase domestic procurement and identify supply chain vulnerabilities of certain essential medicine and products. This “Buy...more

New and Pre-Existing Federal Waivers and Flexibilities Available to Health Care Providers During a National Emergency

In response to the 2019 novel coronavirus (“COVID-19”) pandemic, one of Congress’s first actions was the passage of emergency supplemental appropriations on March 5, 2020. Then, on March 18, 2020, a subsequent relief bill,...more

DOJ False Claims Act Recoveries FY 2019: Total Collections Rise – Almost 90 Percent Relate to Health Care

Through a January 9, 2020, press release, the Department of Justice (“DOJ”) reported more than $3 billion in total recoveries from settlements and judgments from fraud-related civil matters brought under the False Claims Act...more

New Program Integrity Rule Expanding Medicare Revocation and Denial Authorities Took Effect Yesterday

Yesterday, a final rule issued by the Centers for Medicare & Medicaid Services (CMS) establishing new enforcement initiatives aimed at removing and excluding previously sanctioned entities from Medicare, Medicaid, and the...more

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