Hospice Insights Podcast - A Refresh: What’s New in the New OIG General Compliance Program Guidance
Understanding the HHS OIG’s General Compliance Program Guidance
OMG. . .The OIG is at it Again
Medical Device Legal News with Sam Bernstein: Episode 19
Episode 303 --- Deep Dive into the HHS-OIG Compliance Program Guidance
Navigating GSA Audits Compliance Strategies and Best Practices
DE Under 3: US DOL Inspector General’s Office Report Cites IT Modernization & Security Concerns
Medical Device Legal News with Sam Bernstein: Episode 17
Heed Caution: Takeaways From the OIG's Advance Care Planning Report
Telehealth Risk Report: What the Government Found
UPIC Report Card: The OIG’s Evaluation of the UPICs Provides Insight Into the Future of Hospice Audits
COVID-19 Hospice How-To Series | Pulling the Strings: New OIG Audits Scrutinize How Hospices Used Provider Relief Funds
Beyond Hospice: And They’re Off! The OIG’s Nationwide Review of Hospice Eligibility Has Begun
Health Care Fraud and Abuse Control Program FY 2021 Report
Beyond Hospice: The OIG Renews Its Scrutiny of Home Health Agencies
High Crimes and Misdemeanors: Federal Criminal Aviation Cases From 2021
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
[Podcast] Raul Ordonez on Telehealth
The OIG's Impending Review of Nationwide Hospice Eligibility Demands a Robust Response From Hospices
Rob DeConti on the Latest Guidance and Insights from the OIG at HHS
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-07 (the “Opinion”), to a nonprofit tax-exempt grant-making...more
The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more
On July 22 and July 23, Health and Human Services (HHS) Office of Inspector General (OIG) published two advisory opinions for proposals by pharmaceutical manufacturers to provide fertility support to patients receiving their...more
On July 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more
At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device...more
On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more
On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more
The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more
Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more
The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) announced multiple new OIG Work Plan Items, including two audits, focused on identifying and quantifying improper Medicare and Medicaid...more
Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more
The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more
As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting. Are you prepared for a Sunshine Act audit? Reporting...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
Healthcare compliance risks exist even when a company takes steps to structure its business activities to follow the government's own statements. A recent decision by the U.S. District Court for the Eastern District of...more
A Virginia Federal Judge recently rejected a challenge to a negative Advisory Opinion issued by the Department of Health & Human Services’ Office of Inspector General (OIG) that disapproved of a proposal where certain...more
This Week in Washington: House Energy and Commerce subcommittees look at role of AI and CDC respiratory disease preparedness; FDA releases final rule on prescription drug advertisements....more
On November 29, 2023, Department of Justice (DOJ or Department) policymakers announced explicitly that they are, for the first time, leveraging data analytics to help proactively identify and prosecute crimes in foreign...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more