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New HHS Advisory Opinion Confirms Complete Federal Preemption for PREP Act Cases and Applicability of the Act’s Defenses in...

The US Department of Health and Human Services (“HHS”) issued an Advisory Opinion (“21-01”) Friday, reinforcing how the Public Readiness and Emergency Preparedness Act (“PREP Act” or the “Act”) (1) provides complete...more

Takeaways From AHLA Webinar, "CMS, OIG Insights into Stark and AKS Final Rules Part I: Supporting Value-Based Care"

On Thursday, December 17, 2020, senior representatives of the US Department of Health and Human Services’ Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) delivered a virtual...more

CMS Releases FY2021 Medicare Physician Fee Schedule Final Rule, Permanently Expanding Telehealth, Increasing Rates, and Broadening...

On December 1, 2020, CMS released its FY2021 Final Rule (“Final Rule”) updating the Medicare Physician Fee Schedule (MPFS). The MPFS Final Rule is part of an annual cycle of regulations released during the fourth quarter of...more

More Than a Game Changer: Fourth Amendment to PREP Act Declaration Establishes Federal Jurisdiction, Bolsters Immunities, and...

On December 3, 2020, the U.S. Department of Health and Human Services (HHS) issued another groundbreaking amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). ...more

HHS OIG and CMS Release Historic, Sweeping Reforms to Stark Law and Anti-Kickback Statute Regulations

As mentioned in our earlier report, on November 20, 2020, The Department of Health and Human Services (HHS) Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services (CMS) published two long-awaited final...more

CMS and OIG Announce Long-Awaited Changes to the Federal Stark Regulations and Anti-Kickback Laws

Earlier last Friday, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) of U.S. Department of Health and Human Services (HHS) announced their new, long-awaited rule changes to the...more

Two New HHS Advisory Opinions Dramatically Illuminate the Wide Scope of PREP Act Immunity

The U.S. Department of Health and Human Services (HHS) recently issued two new advisory opinions dramatically illuminating the wide scope of the PREP Act and its immunities for organizations using covered countermeasures in...more

Texas Court of Appeals Reaffirms Key Principles Concerning the Medical Peer Review Privilege

Introduction - A recent decision by a Texas Court of Appeals reaffirms several important principles regarding the medical peer review privilege: (1) communications arguably covered by the peer review privilege need not be...more

HouseCanary Weighs a Bird in Hand… Collect on a $210,000,000 Judgment or Retry the Entire Case

Real estate startup HouseCanary made headlines when it secured a $700 million judgment against Title Source, Inc., now known as Amrock, in a trade secrets misappropriation case. In short, HouseCanary claimed that Amrock...more

Third Amendment to PREP Act Declaration Further Expands Scope of Liability Immunity for Medical Countermeasures Against COVID-19

To assist in the response of the nation’s health care providers to the COVID-19 pandemic, on August 24, 2020, the Secretary for the U.S. Department of Health and Human Services (HHS) issued a Third Amendment to his March 10,...more

Fifth Circuit Holds that Reformation of Texas Non-Competes Is Authorized, and Perhaps Required, at Preliminary Injunction Stage

On August 7, 2020, the Fifth Circuit addressed an issue presently undecided by the Texas Supreme Court; namely, whether reformation of an overbroad non-compete restriction is appropriate, and perhaps even required, at the...more

Louisiana Expands its Non-Compete Statute in Favor of Companies

In a strengthening of company contractual rights, the Louisiana Legislature recently expanded its state non-compete statute by permitting a corporation, partnership, or limited liability company to enter into agreements with...more

50-State Survey of Liability Protections For Senior Living and Long-Term Care Facilities

We are pleased to provide you with our 50-State Survey of Liability Protections for Senior Living and Long-Term Care Facilities. Several states across the country have recently taken executive and/or legislative action...more

Courts Across the Country Continue to Address Trade Secrets Issues

The “return to normal” in courts across the country has brought with it a flurry of trade secrets decisions that address some interesting and instructive issues, both procedurally and substantively....more

HHS Secretary Amends PREP Act Declaration to Clarify Definition of “Covered Countermeasures”

On June 4, 2020, the Secretary for the US Department of Health and Human Services (HHS) issued a Notice of Amendment (Amendment) to his March 10, 2020 Declaration that had applied the federal immunities of the Public...more

OIG Announces Strategic Plan for Oversight of COVID-19 Response and Recovery Efforts

The US Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently announced its “Strategic Plan: Oversight of COVID-19 Response and Recovery,” a document that sets forth OIG top goals and...more

HHS Advisory Opinion Concludes that the PREP Act Preempts Any State or Local Law that Prohibits Pharmacists from Administering...

On May 19, 2020, the US Department of Health and Human Services (HHS) Office of General Counsel (OGC) issued an advisory opinion (Advisory Opinion) finding that the Public Readiness and Emergency Preparedness Act1(PREP Act)...more

Houston First Circuit Court of Appeals Joins the Growing Trend by Holding that the Pre-Amendment TCPA Does Not Protect Certain...

In a case following a familiar trade-secret set of facts, on April 28, 2020, the Texas First District Court of Appeals in Houston reversed the trial court’s grant of a motion to dismiss under the Texas Citizens Participation...more

HHS OIG to Accept Inquiries Concerning the AKS and Other Administrative Enforcement Authorities Directly Connected to COVID-19

To enhance regulatory flexibility necessary to adequately respond to the COVID-19 pandemic, the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently announced that it is accepting...more

Supreme Court Rules Government Must Pay $12 Billion to Health Insurers Under ACA Risk Corridor Program

On April 27, 2020, the US Supreme Court ruled by an 8-1 decision that the federal government must pay billions of dollars to health insurers who sold consumer policies on exchanges under the Affordable Care Act’s (“ACA”)...more

NPDB Waives Query Fees from March through May 2020

To assist hospitals in credentialing physicians during the COVID-19 pandemic, the National Practitioner Data Bank (“NDPB”)—the federal clearinghouse for adverse action reports against physicians—has announced it is waiving...more

Texas Announces Drive-Thru Pharmacy Coronavirus Testing

A critical aspect of the response to the COVID-19 public-health crisis in the United States is the rapid expansion of testing capabilities across the country, with one avenue of expansion being authorized testing by qualified...more

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