Mintz Levin

New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products…more
| Health, Science, Computers, & Technology

FY2017 Massachusetts Budget Update: The House Budget

In a unanimous vote of 156-0, the Massachusetts House of Representatives approved a $39.56 billion spending plan for FY2017 on April 27. Over three days, the House considered more than 1,300 amendments to pass a final budget…more
| Education, Elections & Politics, Health, Transportation

Update: Vivendi Wins Summary Judgment Against Another Class Member As Litigation Winds Down

We speculated in September that a decision to grant summary judgment against a class member in the long-running In re Vivendi Universal, S.A. Securities Litigation, 02 Civ. 5571 (SAS) (S.D.N.Y.) “could have implications for…more
| Business Torts, Civil Procedure, Securities Law

Not Obvious to Combine for a Person of Ordinary Skill in the Art (POSITA)

Summary: Appellant appealed to the Patent Trial and Appeal Board (“Board”) an obviousness rejection to claims directed to a user interface that displays currency trading information. Appellant argued in the appeal that the…more
| Civil Procedure, Intellectual Property

CMS Releases Proposed Rule for MACRA Implementation – Overview and Merit-Based Incentive Payment Systems (MIPS)

On April 27, 2016, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would put in place key parts of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). MACRA impacts a number of…more
| Health

CMS Increases Oversight of Medicaid Managed Care Contracts

As noted in a post published yesterday, CMS issued the final rule regarding Medicaid managed care earlier this week. With this rule, CMS is taking a much more active role in overseeing states’ Medicaid managed care contracts. …more
| Health

Trade Secrets Going Federal

Yesterday, in an overwhelming 410-2 bipartisan vote, the US House of Representatives passed the Hatch-Coons Defend Trade Secrets Act (DTSA), which would for the first time federalize trade secrets law and provide uniformity (and…more
| Civil Procedure, Civil Remedies, Elections & Politics, Intellectual Property, Labor & Employment Law

Is it Debt or is it Not? Proposed Treasury Regulations Would Significantly Change Debt vs. Equity Analysis

Earlier this month, the IRS and Treasury Department proposed new Treasury regulations (the “Proposed Regulations”) under Section 385 of the Internal Revenue Code. The Proposed Regulations would significantly modify the tax…more
| Commercial Law & Contracts, Finance & Banking, Taxation

Mark Your Calendars: BPA Prop 65 Warnings Required as of May 11, 2016; Styrene Also Added to the Prop 65 List

Earlier this month, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) issued a Notice of Emergency Action to allow temporary use of a standard point-of-sale warning message for bisphenol A (“BPA”) exposures…more
| Administrative Law, Consumer Protection, Environmental Law, Products Liability

After New York, Florida Curbs Surprise Bills for Emergency and Out-of-Network Services

It is generally understood that if a managed care member utilizes the services of a non-participating provider, the member could incur significant out of pocket expenses. However, there are instances where a member may…more
| Consumer Protection, Health, Insurance

Dodd-Frank and Executive Compensation – Part 1: Status Update

It’s been over five years since the signing of the Dodd-Frank Wall Street Reform and Consumer Act (“Dodd-Frank”) and we are still waiting for the U.S. Securities and Exchange Commission to finalize rules on several provisions…more
| Commercial Law & Contracts, Finance & Banking, Labor & Employment Law, Securities Law

FTC Settles Monopolization Charges Stemming from Contract Exclusivity Terms Used by First-to-Market Medical Polymer Maker

The mere possession of monopoly power does not violate federal antitrust laws. The laws only address the anticompetitive acquisition, maintenance, or abuse of that power. The Federal Trade Commission (“FTC”) entered into a…more
| Antitrust & Trade Regulation, Civil Remedies, Commercial Law & Contracts, Health, Science, Computers, & Technology

Senate Passes First Comprehensive, Bipartisan Energy Bill Since 2007

By a vote of 85-12, the Senate passed a sweeping bipartisan energy bill, S.2012 – the Energy Policy Modernization Act of 2016, last Wednesday. The bill’s passage marks the first time in almost a decade since the Senate has…more
| Elections & Politics, Electronic Discovery, Energy & Utilities

Breach Response Portal Added by Massachusetts Regulator

If you have had to provide data breach notices across any number of states (and who hasn’t….), you would know that they vary widely in how those notices must be provided to state regulators. In some states (for example,…more
| Civil Procedure, Consumer Protection, Privacy, Science, Computers, & Technology

Between a Rock and a Hard Place: Federal Circuit Says It's Required to Accord the PTAB Deference Until Instructed Otherwise by SCOTUS or Congress

On Tuesday, April 26, 2016, the Federal Circuit issued an order denying a petition filed by Merck & Cie for rehearing en banc of an Inter Partes Review (“IPR”) final written decision by the Patent Trial and Appeal Board holding…more
| Administrative Law, Civil Procedure, Intellectual Property
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