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Clarity and Transparency: DOJ Issues Updated Corporate Compliance Guide

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By Susrut A. Carpenter, Carl W. Hittinger and George A. Stamboulidis On April 30, 2019, the Criminal Division of the U.S. Department of Justice (“DOJ”) released a new corporate compliance guidance document for prosecutors titled “Evaluation of Corporate Compliance Programs” (“Guidance”). The Guidance sheds light on how the DOJ evaluates the effectiveness of a company’s compliance program – whether … Continue Reading

Five New Team Members Join BakerHostetler’s National Healthcare Practice

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Partner Mark A. Kadzielski and Counsel Jeeyoung Kim have joined BakerHostetler in our Los Angeles office. Mark focuses his practice on representing hospitals, medical staffs, managed care enterprises and institutional and individual healthcare providers through government regulatory and licensing matters, peer review, joint commission accreditations, credentialing, compliance and corporate government oversight, and Medicare certification. Jeeyoung will work closely with … Continue Reading

Hurricane Harvey Special Alert

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Hurricane Harvey has left our Houston and Texas communities with significant recovery and restoration needs. As attorneys, we struggle with how we can be most helpful. It is in this spirit, that we have compiled a Special Alert to help our clients, friends, family and community. In the days and weeks ahead, our work will … Continue Reading

Justice Department Sets Standards for Evaluation of Corporate Compliance Programs

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By John J. Carney, Margaret E. Hirce, Bari R. Nadworny and Jacqlyn Rovine Since the U.S. Department of Justice’s (DOJ) announcement of its new compliance counsel expert in November 2015, many have been waiting patiently for additional insight into the DOJ’s emphasis on corporate compliance programs. In April 2016, the DOJ issued its Federal Corrupt … Continue Reading

Our 10 Most Popular Blog Posts of 2016

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Texas Open Carry Law: FAQs for Hospitals and Healthcare Facilities Year of the Bundle: CMS Proposes New Mandatory Cardiac Bundles and Expansion of CCJR Trump Administration: Impact on Healthcare Policy The Future of Provider-Based Status Post-BBA 2015 The Deeper Dive: Section 1557 Attempts to Return the “Care” to “Healthcare” Making Sense of MACRA FY 2017 … Continue Reading

January 18, 2017 Webinar: What to Expect in Trump’s First 100 Days

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After years of gridlock, Congress is poised to unleash a flurry of legislative activity early in 2017. The agenda is jam-packed as the Republican-led Congress targets major changes to the Affordable Care Act, Dodd-Frank, taxes and a host of Obama administration regulatory initiatives. Republicans will leverage their congressional majorities to advance their policy priorities, but … Continue Reading

California OSHA Sets the Bar by Adopting the Strongest Workplace Violence Prevention Standard in the Nation

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On Oct. 21, 2016, after nearly two years of meetings and work, the California Division of Occupational Safety and Health Administration (Cal/OSHA) adopted a standard intended to reduce workplace violence against healthcare workers. This is a monumental action by Cal/OSHA for at least three reasons. First, federal OSHA currently has no specific standard governing workplace … Continue Reading

Post-Election Webinar

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BakerHostetler’s Federal Policy team is working to analyze the impact of the 2016 election on federal policy issues. After all the votes are counted, please join the team, led by former Congressman Mike Ferguson, for a “morning-after briefing” during which we will analyze the election results and discuss how changes in the White House and … Continue Reading

Post-Election Webinar by the BakerHostetler Federal Policy Team

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As the dust settles after the presidential candidates’ first debate, BakerHostetler’s Federal Policy team continues to analyze the impact of the 2016 election on federal policy issues. After all the votes are counted, please join the team, led by former Congressman Mike Ferguson, for a “morning-after briefing” during which we will analyze the election results … Continue Reading

DOJ Attempts to Encourage Corporate Self-Disclosures With the Announcement of a One-Year FCPA Pilot Program

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By John J. Carney, Steven M. Dettelbach, George A. Stamboulidis, Jonathan R. Barr,Lauren J. Resnick, and Jonathan B. New Pursuing a classic “carrot and stick” approach to incentivizing corporate self-disclosure of the Foreign Corrupt Practices Act (FCPA) violations and individual wrongdoing connected to FCPA violations, the DOJ Fraud Section announced a new FCPA pilot program aimed at providing transparency into … Continue Reading

Biologics and Biosimilars in the U.S. and Europe

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As the pace of biosimilars development picks up, many pharmaceutical companies are looking for guidance in understanding the patent and regulatory landscapes in the United States and in Europe. This seminar will provide practical advice on the most recent legal developments, preparing for biosimilar approval and patent and litigation strategies. Our speakers from BakerHostetler and … Continue Reading

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA, and Antitrust Terrain

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Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of agreements with competitors, including generic and biosimilar manufacturers, is frequently employed as part of a life cycle management strategy. However, recent changes in patent, regulatory, and antitrust … Continue Reading

Our 10 Most Popular Blog Posts of 2015

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Out-of-network billing practices, the Medicare SGR fix, Stark Law policy changes, the “Tuomey” judgment, 21st Century Cures legislation, Part D policy changes, the two-midnight rule, regulation of Medicaid managed care, 340B, quality initiatives and healthcare delivery reform were among the topics addressed by the Health Law Update’s 10 most popular blog postings of 2015. As … Continue Reading

Rosebush and Holmes Author Article on Contract Pharmacies and 340B Compliance in Journal of Health Care Compliance

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Partner Lee Rosebush and Associate Lindsay Holmes authored an article published in the November-December 2015 issue of the Journal of Health Care Compliance. The article, “340B Compliance Issues: Contracting with Contract Pharmacies,” analyzes the compliance issues associated with the use of contract pharmacies by a covered entity in the 340B setting. Rosebush and Holmes emphasize that such covered entities must … Continue Reading

HHS OIG Creates New Taskforce to Pursue Civil Monetary Penalties and Exclusions

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If you have any questions concerning this article, please contact: B. Scott McBride at smcbride@bakerlaw.com or 713.646.1390; Greg Saikin at gsaikin@bakerlaw.com or 713.646.1399 from our Healthcare Investigation and Enforcement team; John J. Carney at jcarney@bakerlaw.com or 212.589.4255; George A. Stamboulidis at gstamboulidis@bakerlaw.com or 212.589.4211 from our White Collar Defense and Corporate Investigations team; or Hilary … Continue Reading

BakerHostetler Adds 32-Lawyer Group in Atlanta, Including 12 New Partners

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Addition includes large healthcare team plus corporate group; arrivals mark substantial enhancement to national healthcare/life sciences practice as well as firm’s Southeast presence ATLANTA, June 1, 2015 — BakerHostetler has made a significant expansion to its Atlanta office with the addition of a 32-member team from McKenna Long & Aldridge LLP. The incoming group adds … Continue Reading

FDA Addresses Compounding of Animal Drugs From Bulk Drug Substances

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The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing compounding of animal drugs from bulk drug substances. A separate Notice announced that FDA is soliciting nominations for the Bulk Drug Substance List … Continue Reading

Justice to Target Corporations and C-Suite Executives in the Healthcare Industry

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On Thursday, May 14, 2015, at a meeting of the American Bar Association’s Healthcare Fraud Section, Leslie Caldwell, the Assistant Attorney General for the Department of Justice (DOJ) Criminal Division, declared stamping out healthcare “fraud and holding those who commit this fraud accountable are core missions of the Criminal Division and the Justice Department.” In … Continue Reading

BakerHostetler To Add 30-Lawyer Team in Atlanta

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Addition of Former McKenna Long & Aldridge Attorneys Catapults Atlanta Office to Full-Service Capabilities BakerHostetler announces the addition of a 30-lawyer healthcare, corporate, real estate, and litigation team to its Atlanta office. The group of lawyers from McKenna Long & Aldridge will be joining BakerHostetler on June 1 following a vote of the BakerHostetler partnership. … Continue Reading

Webinar — The Anthem Data Breach: What Employers Need to Know

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Wednesday, February 11, 2015 | 1:00 p.m. – 2:00 p.m. EST | Register Now >>  The recently disclosed Anthem data breach may affect as many as 80 million current and former members and has significant implications for employers. Depending on the nature of the contractual relationship with Anthem, employers may have legal obligations, particularly regarding … Continue Reading
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