The Washington State Supreme Court significantly expanded the scope of potential hospital tort liability for the allegedly negligent actions of nonemployee, independently contracted emergency room service physicians, and...more
This Update is the third installment of the ongoing series covering Washington state’s new My Health My Data Act (the Act). Part 1 provided a high-level outline of the entities regulated under the Act and the corresponding...more
6/8/2023
/ Biometric Information ,
Genetic Materials ,
Gramm-Leach-Blilely Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Privacy Rule ,
Mental Health ,
PHI ,
Privacy Laws ,
Reproductive Healthcare Issues ,
Small Business
A defendant’s knowledge of and subjective beliefs about the meaning of legal requirements—not what an objectively reasonable person may have believed—are what matters when determining whether a defendant “knowingly” submitted...more
6/6/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Fraud ,
Healthcare ,
Oral Argument ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reasonable Interpretations ,
Safeco ,
Safeco Insurance Co of America v Burr ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
As detailed in Part 1 of this ongoing series, Washington Governor Jay Inslee signed the state’s My Health My Data Act (the Act) into law on April 27, 2023. The Act is a first-of-its-kind law that creates new privacy...more
This is the second of a three-part series on the hot legal topics surrounding generative artificial intelligence (AI) (see Part 1: The Latest Chapter in Copyrightability of AI-Generated Works).
As the quality of...more
4/21/2023
/ Artificial Intelligence ,
Artists ,
Authorship ,
Copyright ,
DMCA ,
Entertainment Industry ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Investors ,
IP License ,
IP Litigation ,
Machine Learning ,
Technology Sector ,
The Copyright Act
The Centers for Medicare and Medicaid Services (CMS) published its final rule regarding the Medicare Advantage (MA) Risk Adjustment Data Validation (RADV) program in early February 2023. Among other matters, the final rule...more
The U.S. Department of Justice (DOJ), Antitrust Division, recently withdrew three sets of guidelines that had been relied upon heavily by the healthcare industry: the 1993 Antitrust Enforcement Policy Statements Issued for...more
2/8/2023
/ Antitrust Division ,
Antitrust Litigation ,
Antitrust Provisions ,
Antitrust Violations ,
Competition ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare ,
Investigations ,
Legislative Agendas ,
Policy Statement ,
Unfair Competition
COVID-19 has financially stressed the U.S. healthcare system in several ways. In many cities, hospitals have needed to add healthcare capacity (especially ICU beds) to serve rapidly increasing numbers of COVID-19 patients. At...more
The U.S. Department of Health and Human Services (HHS) recently announced two new targeted distributions from the CARES Act Provider Relief Fund (the Provider Relief Fund) to assist in the response to the medical and economic...more
In recent days, the federal government has taken two significant steps to increase healthcare funding to assist providers in responding to the medical and economic consequences of the novel coronavirus pandemic.
$100 Billion...more
4/30/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Families First Coronavirus Response Act (FFCRA) ,
Federal Funding ,
Fee-for-Service ,
Health Care Providers ,
Healthcare Provider Corporations ,
Indian Health Service (IHS) ,
Medicare ,
Paycheck Protection Program and Health Care Enhancement Act ,
Public Health ,
Relief Measures ,
Rural Health Care Providers ,
Uninsured Patients ,
Virus Testing
The Coronavirus Aid, Relief, and Economic Security Act, known as the “CARES Act,” which became law on March 27, 2020, appropriates $100 billion to the Public Health and Social Services Emergency Fund to reimburse providers...more
The Coronavirus Aid, Relief, and Economic Security Act, known as the “CARES Act,” became law on March 27, 2020. The CARES Act implements wide-ranging changes to law and funding designed to ameliorate the coronavirus...more
The federal Department of Health and Human Services (HHS) on March 13, 2020, invoked its authority under section 1135 of the Social Security Act (the act) to waive certain requirements that providers normally must meet to...more
03.16.2020 | Updates By a vote of 363-40 the U.S. House of Representatives passed H.R. 6201, the Families First Coronavirus Response Act, on March 14, 2020. The bill now proceeds to the U.S. Senate, and the White House has...more
The U.S. Department of Justice (DOJ) has reached a settlement with hospice company AseraCare, closing a 12-year-old saga that carries substantial implications for False Claims Act (FCA) enforcement in cases involving a...more
3/10/2020
/ Department of Justice (DOJ) ,
Evidence ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospice ,
Jury Instructions ,
Medical Necessity ,
Medicare ,
Motion For New Trial ,
Objective Falsity ,
Remand
The Department of Justice (DOJ) recovered more than $3 billion in settlements and judgments from civil cases involving the False Claims Act (FCA) in the fiscal year ending September 30, 2019, according to statistics released...more
The solicitor general filed an amicus brief in the U.S. Supreme Court last month supporting the relators’ opposition to certiorari in Gilead Sciences, Inc. v. United States ex rel. Campie, et al., No. 17-936. Yet the...more
12/19/2018
/ Amicus Briefs ,
Department of Justice (DOJ) ,
Discovery ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Gilead Sciences Inc v United States ex rel Campie ,
Manufacturers ,
Materiality ,
Misrepresentation ,
Motion to Dismiss ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Prescription Drugs ,
Qui Tam ,
Reimbursements ,
Relators ,
Remand ,
Solicitor General
The U.S. Court of Appeals for the Ninth Circuit Court raised the bar last week for what states must prove to establish that their Medicaid provider reimbursement rates are sufficient to ensure a robust network of providers...more
The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more
9/23/2015
/ Amarin ,
Commercial Speech ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Misbranding ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs
In a ruling with significant implications for state professional licensing boards and their members, on February 25, 2015, the United States Supreme Court found that practitioner-controlled state boards do not have inherent...more
On May 30, 2014, the Departmental Appeals Board (DAB) issued a decision invalidating the long-standing National Coverage Determination (NCD) prohibiting Medicare payment for transsexual surgery (now known as gender...more
On April 22, the U.S. Department of Health and Human Services (HHS) announced settlements with both Concentra Health Services (Concentra) and QCA Health Plan, Inc. (QCA). Through these latest settlements, HHS is reiterating...more
As of August 1, 2013, pharmaceutical companies and medical device manufacturers are required to report to the federal government payments made to physicians under the Physician Payment Sunshine Act (PPSA). ...more
8/23/2013
On August 2, 2013, the Centers for Medicare and Medicaid Services (CMS) issued an advance copy of its final rulemaking that adopts a new approach to evaluating the medical necessity of inpatient hospital admissions. ...more
The Centers for Medicare & Medicaid Services (CMS) released a ruling and an interim rule that, effective immediately, will allow hospitals to rebill certain inpatient hospital services as outpatient services for one year...more