On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule adopting changes to federal regulations governing research misconduct involving federally funded research (Final Rule). The regulations have...more
9/25/2024
/ Appeals ,
Confidential Information ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Documentation ,
False Claims Act (FCA) ,
Final Rules ,
Fraud ,
HHS Office of Research Integrity (ORI) ,
Investigations ,
New Regulations ,
Plagiarism ,
Public Health Service (PHS) ,
Statute of Limitations ,
Transcripts ,
Willful Misconduct
Friday the 13th is not all bad luck. On September 13, 2024, the United States Court of Appeals for the Eighth Circuit’s published its much-anticipated decision in United States ex rel. Holt v. Medicare Medicaid Advisors,...more
Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...more
3/13/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Enforcement ,
False Claims Act (FCA) ,
Fee-for-Service ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
OIG ,
Provider Payments ,
Regulatory Requirements
On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct...more
The Health Resources and Services Administration (HRSA) Uninsured Program (UIP), which reimbursed providers for provision of COVID-19 related services to uninsured individuals, paid out more than $24.5 billion in claims....more
8/18/2023
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement ,
Fraud ,
HRSA ,
Medicaid ,
Medicare ,
Noncompliance ,
OIG
Decentralized Clinical Trials (DCTs) are clinical trials where some or all trial-related activities occur at locations other than traditional clinical trial sites, such as via telemedicine or in a clinical trial participant’s...more
The Supreme Court today issued its ruling on one of the most significant False Claims Act (FCA) cases it has considered in the last several years. In the consolidated cases of United States ex rel. Schutte et al. v. SuperValu...more
In a 2-1 opinion issued on April 5, the Seventh Circuit Court of Appeals again held that an objectively reasonable interpretation of a relevant statute or regulation precludes the required finding of intent under the False...more
The Fourth Circuit Court of Appeals is now the latest in a growing number of courts holding that an objectively reasonable interpretation of governing law defeats the requisite element of intent or “scienter” under the False...more
In a much-awaited Seventh Circuit decision, the court joined four other circuits in endorsing the “objective reasonableness” defense under the federal False Claims Act (FCA). In a 2-1 panel decision, the court not only upheld...more
8/30/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Corporate Counsel ,
Drug Pricing ,
Fair Credit Reporting Act (FCRA) ,
False Claims Act (FCA) ,
Medicaid ,
Medicare Part D ,
Price Match Guarantees ,
SCOTUS ,
Summary Judgment ,
Wal-Mart
On June 3, 2021, the Northern District of Texas ruled on a novel issue in U.S. v. Hagen (Case No. 3:19-CR-0146-B (N.D. Tex.)). In a health care fraud conspiracy case against DME suppliers, the court held that a good faith...more
On Monday February 22, 2021, the U.S. Supreme Court declined to grant certiorari in CareAlternatives v. United States (CareAlternatives), a case on appeal from the Third Circuit that could have assessed the issue of...more
Many health care providers treating senior patients rely on Medicare reimbursement and undertake significant measures to ensure proper billing and compliant practices. However, providers across the country may soon be subject...more
12/10/2020
/ American Medical Association ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospice ,
Medicare ,
Petition for Review ,
PHRMA ,
Physician Medicare Reimbursements ,
Qui Tam ,
SCOTUS
In April 2020, the Department of Health and Human Services (HHS) revealed a plan to disperse $175 billion in funding for health care providers allocated by the Coronavirus Aid, Relief, and Economic Security (CARES) Act and...more
Businesses that applied for a Small Business Administration’s (SBA) Paycheck Protection Program (PPP) loan have a chance to change their minds if they return the money by May 14, 2020.
With the onslaught of COVID-19...more
Businesses that applied for a Small Business Administration’s (SBA) Paycheck Protection Program (PPP) loan have a chance to change their minds if they return the money by May 7, 2020.
With the onslaught of COVID-19...more
With the onslaught of COVID-19 business closures, the government invited businesses around the country to apply for CARES Act relief to help survive the closures. Many have chosen to apply for assistance through the Small...more
Following the Eleventh Circuit’s and Third Circuit’s recent rulings in United States v. AseraCare and United States v. Care Alternatives, respectively, the Ninth Circuit Court of Appeals has now also addressed the question of...more
The COVID-19 virus crush is upon us at this moment. Like in 2008 with TARP, the government has invited businesses around the country to apply for CARES Act relief to help survive this pandemic...more
4/9/2020
/ Affiliated-Business Arrangements ,
Board of Directors ,
Business Interruption ,
CARES Act ,
Coronavirus/COVID-19 ,
Economic Injury Disaster Loans ,
False Claims Act (FCA) ,
Federal Loans ,
Financial Stimulus ,
Health Insurance ,
Paycheck Protection Program (PPP) ,
Payroll Taxes ,
Relief Measures ,
SBA ,
SBA Lending Programs ,
Shareholders ,
Small Business ,
Stocks ,
Tax Relief
In times of crisis, there are heroes, villains, victims, and everyone in between. Amidst the COVID-19 crisis, many valiant efforts are under immense time pressure—to care for the ill, to protect the vulnerable, to find and...more
The United States Court of Appeals for the Third Circuit ruled last week that whistleblower relators need not show “objective falsity” to prove their claims, and that a dispute among physician experts about a clinical...more
3/12/2020
/ False Claims Act (FCA) ,
Health Care Providers ,
Hospice ,
Insurance Fraud ,
Life Sciences ,
Medicare ,
Objective Falsity ,
Physicians ,
Professional Liability ,
Qui Tam ,
Relators ,
Scienter ,
Triable Issue of Fact ,
Whistleblowers
Federal enforcers typically announce (formally as well as informally) work plans or focus areas for the upcoming year that can provide some guidance as to where providers might anticipate enforcement action and, where they...more
Health care providers, government contractors, and others who receive money from the federal government are at greater risk of suit under the False Claims Act (FCA), 31 U.S.C. §§ 3729 et seq., following the Supreme Court’s...more
5/31/2019
/ Appeals ,
Cause of Action Accrual ,
Cochise Consultancy Inc v United States ex rel Hunt ,
Dismissals ,
False Claims Act (FCA) ,
Federal Contractors ,
Intervenors ,
Limitation Periods ,
Qui Tam ,
Reaffirmation ,
Relators ,
Reversal ,
SCOTUS ,
Statute of Limitations
In a memo leaked last year (the Granston Memo), the U.S. Department of Justice (DOJ) instructed its prosecutors to more seriously consider dismissing meritless whistleblower False Claims Act (FCA) cases when it is in the...more
On May 7, 2019, the Department of Justice (DOJ) released guidance for civil prosecutors in determining how to assess cooperation in False Claims Act (FCA) cases. See DOJ’s press release and its revised manual. In particular,...more