Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Hospice Insights Podcast - A Rise in Medicare Deactivations: Tips for Avoiding This Financial Pain
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 187: South Carolina Hospitals and Healthcare Industry Trends with Thornton Kirby, SCHA President
A Fond Farewell: Musings on the End of the Medicare Advantage Hospice Carve-In Demonstration
Video: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 173: Improving rural health care with Dr. Kevin Bennett, the Director of the Research Center for Transforming Health and the
Medical Device Legal News with Sam Bernstein: Episode 19
Counsel That Cares - The Private Payer's Perspective on Value-Based Care
Opting Out of Medicare: When and How to Do It
Medical Device Legal News with Sam Bernstein: Episode 11
Show Me the Money: New Study Confirms Hospice Saves Money for Medicare
An Unwanted Spotlight: DOJ Announces Hospice Fraud Is Top Priority
The Chartwell Chronicles: Medicare & Medicaid
Navigating EMTALA Rules
Heed Caution: Takeaways From the OIG's Advance Care Planning Report
Podcast: The End of the Public Health Emergency – What's to Come? – Diagnosing Health Care
Patient Steering and Charting
Telehealth Risk Report: What the Government Found
Do You Have a Backup? Building Redundancies Into Your Written Certification Process
Teva Pharmaceuticals, the largest generic drug manufacturer in the United States, has agreed to pay $450 million to resolve allegations of violating the False Claims Act and Anti-Kickback Statute arising from purported...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...more
How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District...more
Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more
On September 18, 2020, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) issued Advisory Opinion 20-05. In this unfavorable Advisory Opinion, OIG declined to approve a pharmaceutical...more
On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more
Can a pharmaceutical manufacturer provide free items or services to financially needy Medicare and Medicaid beneficiaries without running afoul of the Beneficiary Inducements Civil Monetary Penalty (CMP) or the Anti-Kickback...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...more
On November 28, 2017, the Office of Inspector General (OIG) rescinded advisory opinion 06-04, in which it had previously determined that a charity’s (Requestor) proposal to provide assistance to financially needy Medicare...more
The Department of Health and Human Services Office of Inspector General (the OIG), on November 28, 2017, issued a Rescission Letter terminating Advisory Opinion Number 06-04 (Advisory Opinion 06-04). In Advisory Opinion...more
As we discussed last week, Nevada’s Governor has signed into law SB 539, which provides sweeping transparency legislation related to several aspects of the pharmaceutical industry. Nevada joins several other states in...more
Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more
On November 13, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-14. The Arrangement at issue is a charitable program designed to assist financially needy...more
You probably heard about the recent price hike for a drug critical to AIDS patients when the manufacturer sold it to an evil hedge fund manager who promptly marked it up 5,000%. This prompted Los Angeles Times columnist...more
On January 29, the Centers for Medicare & Medicaid Services (CMS) announced its plan to propose changes to the Electronic Health Record Incentive Program (EHR Incentive Program). According to CMS, the rule will address...more
In an effort to address new concerns about the independence of charity patient assistance programs (PAPs), the Office of Inspector General (OIG) released its Supplemental Special Advisory Bulletin: Independent Charity Patient...more
On May 21, 2014, the Office of the Inspector General ("OIG") of the Department of Health and Human Services issued a Supplemental Special Advisory Bulletin ("Supplemental Bulletin") addressing the risks that Independent...more
On July 29, 2013, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) released a memorandum report finding that Medicare paid more on average for short inpatient stays than for...more