Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more
8/29/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
OIG ,
Telehealth
The 60-day Refund Rule, created by the 2010 Affordable Care Act, requires providers to report and return Medicare and Medicaid overpayments within 60 days of identifying them. See Section 1128J(d) of the Social Security Act,...more
7/16/2024
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Deadlines ,
False Claims Act (FCA) ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part B ,
Medicare Part C ,
Medicare Part D ,
Overpayment ,
Proposed Regulation ,
Refunds
On June 28, 2024, the Supreme Court rejected the doctrine of Chevron deference in the closely watched case of Loper Bright Enterprises v. Raimondo. In a 6-3 decision, the Court held that Chevron’s rule that courts must defer...more
7/2/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Federal Health Care Programs (FHCP) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
HRSA ,
Loper Bright Enterprises v Raimondo ,
Magnuson-Stevens Act (MSA) ,
Medicaid ,
Medicare ,
National Marine Fisheries Service ,
SCOTUS
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
2/2/2024
/ Business Operations ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Exclusions ,
Healthcare Fraud ,
Medicaid ,
Medicare Advantage ,
New Guidance ,
OIG ,
Risk Assessment ,
Self-Disclosure Requirements ,
Telemedicine
On December 7, 2023, the Senate Budget Committee (the “Committee”) launched a bipartisan investigation into the reality of private equity ownership of hospitals in the United States. This investigation stems from concerns...more
In connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, and with acknowledgment by the Chief Counsel to the Inspector General, Rob DeConti, of the long...more
11/8/2023
/ Advisory Opinions ,
Anti-Kickback Statute ,
Audits ,
Civil Monetary Penalty ,
Compliance ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Healthcare Fraud ,
OIG ,
Private Equity ,
Risk Assessment ,
Self-Disclosure Requirements
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
On July 13, 2023 the Office of Audit Services of the Department of Health & Human Services Office of Inspector General (OIG) released the long-awaited audit (A-02-21-01013) of the Health Resources and Services Administration...more
Continuing a now annual tradition, the Centers for Medicare & Medicaid Services (CMS) has included expansions and enhancements to its authorities to deny enrollment or revoke a provider’s Medicare billing privileges...more
7/18/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Diagnostic Tests ,
DMEPOS ,
Durable Medical Equipment ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Medicare ,
Misdemeanors ,
OIG ,
Proposed Rules ,
Revocation ,
Risk Assessment
Session #1: State of the Healthcare Industry Effective Compliance Plans and Enforcement Trends -
In their discussion of compliance program effectiveness and enforcement, attorneys Kolarik and Waltz and Ms. Sumner...more
2/23/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Dispute Resolution ,
Enforcement ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
Mental Health ,
No Surprises Act (NSA) ,
Physician Fee Schedule ,
Public Health Emergency ,
Risk Assessment
As part of the $1.7 million omnibus spending bill that became law December 29, 2022, the Centers for Medicare & Medicaid Services (CMS) extended, through December 31, 2024, the Acute Hospital Care at Home (H@H) initiative...more
On August 17, 2022, the Centers for Medicare and Medicaid Services (CMS) issued a bulletin (Bulletin) to states addressing potentially inappropriate cost-based proposals and practices related to governmental ambulance...more
One Health Resources and Services Administration program, “COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured,” has been a huge source of...more
4/8/2022
/ American Rescue Plan Act of 2021 ,
CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Families First Coronavirus Response Act (FFCRA) ,
Health Care Providers ,
HRSA ,
OIG ,
Reimbursements ,
U.S. Treasury
On March 15, 2022, the Health Resources & Services Administration (HRSA) announced that the Uninsured Program will stop accepting claims for COVID-19 testing and treatment on March 22, 2022 at 11:59 PM ET due to lack of...more
Demand for COVID-19 tests, including over-the-counter at-home tests, has soared with the surge of the Omicron variant of the COVID-19 virus. However, health care providers, employers, and individuals have lacked clarity on if...more
On November 8, 2021, the Department of Health & Human Services (HHS) Office of Inspector General (OIG) released a revised and renamed Provider Self-Disclosure Protocol: the OIG “Health Care Fraud Self-Disclosure” protocol...more
In a Press Release issued on October 14 2021 by the Office of Massachusetts Attorney General Maura Healy, a potentially groundbreaking settlement was announced. Below is an excerpt from the release, followed by our takeaways....more
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
Laboratory testing is a key factor in identifying or diagnosing COVID-19 patients, including during the asymptomatic phase, and determining appropriate treatment. With respect to COVID-19, laboratory testing is also critical...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
On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released its long-awaited Proposed Rule (Proposed Rule) updating and clarifying the physician...more
10/17/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Medicare ,
Physicians ,
Proposed Regulation ,
Self-Referral ,
Stark Law ,
Value-Based Care
Welcome to Foley & Lardner LLP’s Health Care MarketTrends. In this issue, we examine private equity investment in specialty areas of the health care industry, specifically dermatology and orthopedics....more
9/17/2019
/ Anti-Kickback Statute ,
Audits ,
Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Coding ,
Health Care Providers ,
Hospitals ,
Investors ,
Medicaid ,
Medicare ,
Private Equity ,
Private Equity Firms ,
Specialty Healthcare ,
Stark Law
At this early point in the 2020 presidential race, it appears that a key issue for the candidates will be a push for national health insurance, or some variation thereof, possibly even including proposals that Medicare or...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