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
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
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
The House and Senate are in recess and will return next week to resume healthcare activity. The Senate Health, Education, Labor and Pensions (HELP) Committee is seeking feedback on a staff-level bipartisan discussion draft to...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 October 5, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-19 (Advisory Opinion), in which it determined that a proposed oncology drug discount arrangement could constitute grounds for the...more
Health plans, carriers, and other entities involved in the delivery of health care may often find themselves up against a complex maze of anti-kickback laws and regulations when trying to create new health care programs...more
What New Obligations Does the No Surprises Act Impose on Health Systems and Health Plans—and How Can You Prepare for the Impact? Learn the Answer at a New Manatt Webinar. The No Surprises Act (NSA)—set to take effect...more
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has been actively enforcing HIPAA regulations this year, including a series of seven settlements under OCR’s Right of Access...more
The U.S. healthcare industry remains at a crossroads. The healthcare reform legislation passed under President Barack Obama in 2010, officially called the Patient Protection and Affordable Care Act (ACA) but widely referred...more
In FY 2018, the federal government won or negotiated more than $2.3 billion in healthcare fraud judgments and settlements. During that same period, investigations conducted by the Department of Health and Human Services’...more
The Oregon Department of Consumer and Business Services (“Oregon Department”) recently announced it had entered into an Order to Cease and Desist, Final Order Assessing Civil Penalty and Consent to Entry of Order (“Order”)...more
A single, multidisciplinary entity, like a university, may include certain departments that use PHI, and other departments that do not. Such institutions are eligible to (and should) self-identify as “hybrid entities” to...more
With Advisory Opinion 18-09, the OIG continued its trend of approving arrangements between Medicare Supplemental Health Insurance (Medigap) insurers and preferred hospital network organizations (PHOs). As in prior advisory...more
The recent $575,000 settlement with EmblemHealth signals a push from AG Schneiderman “for stronger security laws and hold[ing] businesses accountable for protecting their customers’ personal data.” Noting New York’s “weak and...more
A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more
It’s hard to keep up with all the recent changes to labor and employment law. While the law always seems to evolve at a rapid pace, there were an unprecedented number of changes each month in 2017—and if January is any...more
With Advisory Opinion 17-04, issued August 24, 2017, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) adds to the ever-growing number of favorable advisory opinions regarding an agreement...more
With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more
After a series of compliance failures leading to the resignation of company’s CEO, the privately-held health care brokerage company Zenefits was just hit with a $7 million dollar settlement by the California Department of...more
Editor's Overview - This month’s newsletter features an article on the DOL’s recently published interim final rule that increases penalties for notice and disclosure violations, which generally became effective on...more
By August 1, 2016, all federal agencies must adjust their civil monetary penalties, including penalties required by the False Claims Act (“FCA”), to account for inflation. Last month, the Railroad Retirement Board, which...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 August 12, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 15-11, finding that a program to supply a limited amount of free cancer drugs to federal health...more
On June 12, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-08. This opinion continues the well-established pattern of favorable advisory opinions which...more