Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
The August Monthly Minute highlights new IRS guidance addressing student loan matching programs, HHS’s increases to civil monetary penalties and Form 5330 paper filing updates....more
As Medicare secondary payer penalties take effect this fall, find out what’s new, what’s on the horizon, and what to watch out for to avoid pitfalls. Join Goldberg Segalla partners Philip Unwin and Jennifer Santoro for a free...more
On June 24, 2024, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released a final rule that disincentivizes healthcare providers from...more
Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...more
Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more
The Emergency Medical Treatment and Active Labor Act ("EMTALA") provides that if a patient comes to a hospital or hospital-owned urgent care center, the hospital and relevant on-call physicians must provide an appropriate...more
Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more
The U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) have started a new effort to educate the public about the Emergency Medical Treatment and Labor Act (EMTALA)....more
This favorable OIG opinion concludes that although the proposed arrangement (“Proposed Arrangement”) to subsidize Medicare cost-sharing obligations for Medicare patients in a cardiac clinical trial (“Study”) would constitute...more
From 1998-2008, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published compliance program guidelines for various industries in the Federal Register....more
The Department of Health and Human Services Office of Inspector General (OIG) recently issued an advisory opinion that explored the limits of a relatively new safe harbor to the federal Anti-Kickback Statute (AKS) that aims...more
On October 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-08, in which it refused to approve a proposal by a manufacturer and distributor of hearing...more
The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more
The Centers for Medicare and Medicaid Services (CMS) published the final rule outlining how civil monetary penalties will be calculated and imposed when Responsible Reporting Entities (RRE) fail to meet their Medicare...more
On October 11, 2023, CMS published a final rule (the Final Rule) regarding how and when CMS will impose civil monetary penalties (CMPs) for Medicare secondary payers (MSPs) that untimely report required information. The Final...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
On September 1, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled “Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency...more
On September 1, 2023, CMS issued the Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency Reporting proposed rule (the Proposed Rule), which imposes nurse staffing...more
On April 12, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released a final rule updating key regulations pertaining to Programs of All-Inclusive Care for the Elderly (“PACE”) (the “Final Rule”). Overall, these...more
On April 4, 2023, CMS issued proposed rules for Fiscal Year (FY) 2024 to update Medicare payment policies for skilled nursing facilities (SNFs) and inpatient psychiatric facilities (IPFs). CMS notes these rules are intended...more
A laboratory company based in Texas, Genotox Laboratories Ltd., recently reached an agreement with the federal government to resolve False Claims Act and Anti-Kickback Statute violations, stemming from allegations related to...more
The Department of Health and Human Services Office of Inspector General (OIG) recently published a new frequently asked question (FAQ) and advisory opinion addressing how to analyze arrangements that may involve providing...more
On February 18, 2023, the Centers for Medicare and Medicaid Services (CMS) extended the timeline for publishing the Medicare Secondary Payer and Certain Civil Monetary Penalties final rule by one additional year, stating that...more
Whether it's reporting to CMS, getting CMS approval, or wondering how to handle LMSAs, this webinar will help answer those questions....more
On February 28, 2023, OIG posted Advisory Opinion 23-02, responding to a request by a pharmaceutical company (the Company) regarding its proposal to offer a free 14-day supply of an enzyme replacement therapy drug to patients...more