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
On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released an Audit and Enforcement Report summarizing its annual Medicare Advantage (Part C) and Prescription Drug (Part D) program audits and enforcement...more
On December 11, 2024, OIG issued a Special Fraud Alert to warn the industry about the fraud and abuse risks associated with abusive Medicare Advantage (MA) organization (MAO) and agent and broker relationships with healthcare...more
The Centers for Medicare & Medicaid Services (CMS) recently made meaningful changes to its regulations interpreting the Affordable Care Act’s (ACA’s) so-called “60-day Rule,” which requires Medicare providers to affirmatively...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
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more
On August 19, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-16 (Advisory Opinion) in which it declined to impose sanctions for an arrangement under which the requestor provides gift cards to...more
This opinion regards the provision of a gift card to certain Medicare Advantage (“MA”) plan enrollees who complete specific steps in an online patient education program....more
On January 19, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a favorable advisory opinion, OIG Advisory Opinion No. 22-01 (the “Opinion”), analyzing a proposed expansion of...more
On November 2, 2021, CMS published the final rule to update the payment policies and rates for services furnished under the Medicare Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgery Center (ASC) Payment...more
On September 18, 2020, OIG issued Advisory Opinion No. 20-05 analyzing a pharmaceutical manufacturer’s proposal to offer direct cost-sharing assistance to Medicare beneficiaries prescribed certain of the manufacturer’s new...more
Transportation is often cited as one of the top barriers to health care for individuals in the United States. To reduce this burden and increase access to care, many health care providers are now partnering with ride-sharing...more
Late last week, CMS released the Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2019 draft Call Letter (Advance Notice...more
On December 7, 2016, the Department of Health and Human Services Office of the Inspector General (OIG) issued a final rule to establish new safe harbors under the anti-kickback statute and civil monetary penalty (CMP) rules,...more
On December 7, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) finalized [PDF] its proposal to update the civil monetary penalty (CMP) regulations – namely, incorporate new CMP authorities...more
As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more
On Friday, the Centers for Medicare & Medicaid Services (“CMS”) issued a long-awaited proposed rule that would drastically change the payment rates for clinical laboratory services beginning January 1, 2017 (the “Proposed...more