AGG Talks: Home Health & Hospice - Reimbursement Audits and Appeals
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
Podcast: Owner's Outlook: Maximize and Safeguard Reimbursement Through Design - Diagnosing Health Care
HealthLaw HotSpot - A Look at Alternative Reimbursement Models in Value-Based Care
The Important and Thriving Role of Private Medical Practices
Value-Based Care and Its Impact on Providers
The Year Ahead: Litigation Hot Spots at a Glance
Teleworking: Amazing or amazingly complex?
(Video) Reimbursement of College Tuition and Fees After COVID-19
Value-based health care: compliance infrastructure
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
Value-based health care: fraud & abuse laws
Value-based health care: issues for pharmaceutical companies
Condo Water Invasion: Potential Medical Liability?
On August 2, health care providers scored yet another significant victory when the US Court of Appeals for the Fifth Circuit affirmed the vacatur of various federal regulations regarding the arbitration procedures used to...more
On August 1, 2024, CMS filed a display copy of its final rule for Fiscal Year (FY) 2025 pertaining to the Inpatient Prospective Payment Systems (IPPS) for general acute care hospitals and long-term care hospitals (LTCHs) (the...more
On June 28, the US Supreme Court overturned the Chevron doctrine — the legal principle that the judiciary should defer to a federal agency’s reasonable interpretation of an ambiguous statute. Chevron reflected the view...more
On July 1, 2024, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) published a final rule...more
Baker Donelson recently published Anticipating SCOTUS Ruling on Chevron Deference – What to Know and Five Ways to Prepare explaining the United States Supreme Court's upcoming ruling which is expected to impact the regulatory...more
Florida Lab Owner Agrees to Pay Over $27 Million to Resolve Three Whistleblower Lawsuits - Daniel Hurt, the prior owner and operator of Fountain Health Services LLC, Verify Health, Landmark Diagnostics LLC, First Choice...more
In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute...more
Leading health authorities have increasingly emphasized how non-medical factors such as socioeconomic status, education, employment, housing, food security, and community support have an outsized impact on health outcomes. By...more
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more
Change Healthcare Cyberattack - On February 21, 2024, Change Healthcare—a healthcare technology company owned by UnitedHealth Group—issued a statement that it had been impacted by a ransomware attack. According to Change...more
ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more
Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations - A New Jersey-based laboratory, RDx Bioscience Inc. (RDX), and its owner and CEO, Eric Leykin, agreed to pay $10,315,023 to the US...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
On September 1, 2023, the D.C. Circuit affirmed the D.C. District Court’s decision in Pomona Valley Hosp. Med. Ctr. v. Azar, 2020 WL 5816486, at *1 (D.D.C. Sept. 30, 2020) requiring CMS to produce affirmative evidence as to...more
Medical Supplier Agrees to Pay $29 Million for FCA Violations - Earlier this month, the US Department of Justice (DOJ) and medical supplier Lincare Holdings Inc. reached an agreement to settle claims that Lincare violated...more
Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...more
On Friday, July 7, 2023, the Centers for Medicare & Medicaid Services (CMS) published their long-awaited proposed remedy to the unlawful 340B drug payment reductions. Background: In 2018, CMS significantly reduced the...more
Walking away from the American Health Law Association’s annual conference, I’m feeling energized from (re)connecting with friends and colleagues, inspired by the complex and transformational work being done throughout the...more
Two bills are moving in the United States House of Representatives that have implications for hospitals and health systems, with material changes proposed regarding pricing transparency requirements, identification and...more
Telehealth experienced massive growth during the COVID-19 pandemic, due in no small part to various regulatory and reimbursement policies that federal agencies implemented following a declaration by the US Department of...more
The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more
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
For nearly three years, federal and state agencies have waived or relaxed regulatory requirements and expanded reimbursement for services due to the COVID-19 public health emergency (PHE), but the signs indicate that the...more
The United States District Court for the District of Columbia granted plaintiffs’ motion to vacate the 2022 OPPS Rule’s 340B rates on a prospective basis, meaning that HHS will pay 340B hospitals the drug’s average sales...more
On September 28, 2022, the US District Court for the District of Columbia vacated the 2022 rule under which the US Department of Health and Human Services (HHS) reduced Medicare Part B payments on 340B drugs paid under the...more