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 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
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
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
The Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...more
Walking away from the American Health Law Association’s annual conference, I’m feeling energized from (re)connecting with friends and colleagues, inspired by the complex and transformational work being done throughout the...more
On May 26, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule titled: “Medicaid Program: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug...more
On February 28, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 23-02 (“Opinion”), which favorably addresses a pharmaceutical manufacturer’s proposal to offer a free limited supply of medication for...more
On February 7, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a report entitled, “Technical Assistance Brief: Implementation of Inflation-Indexed Rebates for Part B Drugs.” ...more
The Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services Office of Inspector General (OIG) continue to issue guidance regarding the implementation of the drug pricing provisions of...more
The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible...more
On January 3, 2023, the Department of Health and Human Services Office of Inspector General (OIG) publicly released two reports with respect to Medicare Part B average sales price (ASP)....more
Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting...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
OIG Warns That Proposed Drug Discounts May Warrant Sanctions - On October 5, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued an advisory opinion assessing a proposal that involved...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit...more
As we noted in our last PBM Regulatory Roundup, there has been a wave of state regulation focused on PBM practices in the wake of Rutledge and Webhi. However, PBMs are also facing federal reform efforts. The Pharmacy Benefit...more
This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more
On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...more
For the first time since 2013, on November 8, 2021, the Health and Human Services Office of Inspector General (“HHS-OIG” or “OIG”) made a number of significant updates to its Health Care Fraud Self-Disclosure Protocol...more
On October 13, 2021, the in-person portion of the annual informaconnect Medicaid Drug Rebate Program (MDRP) Conference concluded in New Brunswick, New Jersey. A day earlier, on October 12, 2021, a joint hearing was held in...more
In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...more
Welcome to the first issue of the Latham & Watkins Drug Pricing Digest. Here, Latham’s government price reporting team provides a digest of recent developments, as reported in the trade press or published directly by...more
Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more
As we begin the new year, we wanted to highlight two final developments from December 2020: First, on Dec. 27, 2020, the stimulus legislation H.R. 133, the Consolidated Appropriations Act of 2021 (link), Pub. L. 116‑260...more
On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more