Michelle McGovern

Michelle McGovern

Manatt, Phelps & Phillips, LLP

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Pharmacy Compounding Update: Regulators Search for the Right Formula

Last November, the Compounding Quality Act (‘‘Act’’) became law after a yearlong national debate about whether—and how—to regulate compounding pharmacies after a tainted injectable prepared at a Massachusetts compounding...more

9/23/2014 - Drug Compounding FDA Pharmaceutical Prescription Drugs

Health Update - July 2014

Avoiding the Regulatory Land Mines of Commercial ACOs - While providers are showing great interest in creating ACOs to participate in the Medicare Shared Savings Program (MSSP), they are showing even greater enthusiasm...more

7/23/2014 - ACOs EHR Halifax Hospital Health Insurance Healthcare HIPAA Medicare Medicare Shared Savings Program Regulatory Standards Reporting Requirements Social Networks Stark Law

Health Update - May 2014

Litigation Arising from the Affordable Care Act: The Blessing and Curse of Interesting Times - The Affordable Care Act (ACA) has brought the most sweeping changes to the healthcare delivery and payment systems in the...more

5/22/2014 - Affordable Care Act CMS Data Breach Data Protection EHR Healthcare Healthcare Reform HIPAA Medicare PHI

Health Update - Feb 25, 2014

Integrating Physical and Behavioral Health: Strategies for Overcoming Legal Barriers to Health Information Exchange - A growing number of Medicaid officials believe that coordinating care across the physical and...more

2/26/2014 - Affordable Care Act CLIA Data-Sharing Eligibility Final Rules FTC Healthcare HHS HIPAA Hospital Mergers Medicaid Medical Records

Health Update -- Dec 19, 2013

The Debate over Specialty Pharmaceuticals: Is the Promise Worth the Price? - ..What’s the Issue? - Specialty pharmaceuticals are a rapidly growing share of total drug expenditures by public and private health...more

12/19/2013 - Biologics FDA Healthcare Pharmaceutical Prescription Drugs Specialty Healthcare

Health Update -- Nov 26, 2013

10 Megatrends Shaping Healthcare’s Next 10 Years - The American healthcare system is undergoing massive change. From transformational policies to disruptive technologies to groundbreaking medical advances, powerful...more

11/26/2013 - Affordable Care Act Big Data Healthcare Healthcare Reform

Little Harm, Big Damages: AvMed Settlement Could Change the Landscape for Privacy Breach Class Actions

On October 21, Florida-based health insurer AvMed, Inc. (AvMed) settled a data breach class action lawsuit for $3 million, even though no plaintiffs in the class demonstrated that they had suffered identity theft or any other...more

11/13/2013 - Damages Data Breach Data Protection Identity Theft Invasion of Privacy Personally Identifiable Information PHI Settlement

Healthcare Law -- Jul 15, 2013

How Does the DOMA Defeat Impact Healthcare Reform and Health Insurance Access? - NOTE: The Supreme Court's 5-4 decision to invalidate the Defense of Marriage Act (DOMA) will affect more than 1,000 federal statutes—and...more

7/16/2013 - Affordable Care Act Delays DOMA Employee Benefits Employer Mandates Health Insurance Health Insurance Exchanges Healthcare Healthcare Reform HHS Medicaid Pay or Play Pharmacies Same-Sex Marriage SCOTUS Shared Responsibility Rule U.S. Treasury

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