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 8, 2024, the Office of Inspector General (OIG) updated its General Questions on Fraud and Abuse Authorities (FAQs) related to the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Prohibition of Civil...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
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
On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part...more
On February 4, 2022, OIG issued Advisory Opinion No. 22-02 in which it responded to a request for an advisory opinion submitted by a hospital system that operates a children’s hospital (Requestor) regarding a proposed...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
As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative...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
On November 15, the Trump Administration released a final rule requiring hospitals to publicly disclose hospital charges, including negotiated prices with third-party payers by January 1, 2021. We outline key considerations...more
August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more
A group of six government-operated fire departments has received a green light from the Office of Inspector General (OIG) to enter into a mutual aid agreement to provide backup emergency ambulance services and to bill for...more
On Aug. 24, 2018, the Office of Inspector General (OIG) issued a request for information (RFI) regarding the Anti-Kickback Statute (AKS) and Beneficiary Inducement provisions of the Civil Monetary Penalty (CMP) law. The...more
On Monday, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published a wide-ranging request for information (RFI) seeking ideas on how it might add or modify safe harbors to the...more
With Advisory Opinion 18-06, issued July 11, 2018, the OIG added to the ever-growing number of favorable advisory opinions addressing an agreement between a Medicare Supplemental Health Insurance (Medigap) insurer and a...more
A non-profit acute care hospital may share cost savings for certain spinal surgeries with neurosurgeons in a multi-specialty physician group following approval by the U.S. Department of Health & Human Services, Office of...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
The Office of Inspector General (“OIG”) of the Department of Health and Human Services has issued a final rule (“Final Rule”) adding new safe harbors to the federal anti-kickback statute, amending existing safe harbors, and...more
The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more
On December 7, 2016, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) issued a final rule to implement revisions to certain Anti-Kickback Statute (AKS) safe harbors, as well as revisions to...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 (HHS), Office of Inspector General (OIG), issued a final rule that will have a widespread impact on health care service providers, medical transport providers,...more
On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary...more
On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...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 October 2, 2014, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) published a proposed rule containing revisions to both the Anti-Kickback Statute (AKS) safe harbors and the civil...more