Administrative Agency Updates

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.
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CMS Announces Risk-Based Adjusted Additional Documentation Request Limits for Institutional Providers

On May 3, 2016, CMS announced the availability of a revised method to calculate additional documentation request (ADR) limits for Institutional Providers in the Recovery Audit Contractor (RAC) Program. Under the new method,...more

Hope For Software Patents In The Post-Alice Landscape

The courts have long been attempting to establish an appropriate framework with which to handle software-based inventions. Even before the Supreme Court decision in Alice Corp. v. CLS Bank International numerous tests have...more

Court Declines to Modify Judgment Based on Collateral Proceedings before the PTAB Finding Claims of Patent-In-Suit Invalid

Summary: In the decision referenced below, the court declined to modify a judgment pursuant to Rule 60(b)(6) of the Federal Rules of Civil Procedure even though the PTAB had found several claims of the patent-in-suit...more

The Problem of Wearing Two Caps Simultaneously – Part I

A favorite teaching tactic in legal ethic courses is putting on and taking off different caps to illustrate the different roles lawyers play in various relationships. This “on again/off again” routine demonstrates that the...more

IPR Motions to Amend: Rays of Hope Despite Gloomy Statistics

The America Invents Act permits patent owners to move to amend claims of a patent subject to inter partes review. However, attempts to amend claims have been largely unsuccessful to date, and some of the hurdles patent owners...more

Privacy Best Practices for Commercial and Private Drone Use Adopted in NTIA Process

Consensus was reached in a proceeding of the National Telecommunications and Information Administration (NTIA) of the U.S. Department of Commerce on a set of privacy best practices for the commercial and recreational use of...more

USPTO Memo Updates Examiner Guidance On Subject Matter Eligibility In View Of Enfish

On May 19, 2016, just weeks after its May 2016 memorandum to examiners providing guidance on subject matter eligibility under § 101, the USPTO issued a new memo updating its guidance to examiners in view of the Federal...more

FAA announces more drone detection testing at JFK Airport

The Federal Aviation Administration (FAA) announced this week that it will be expanding its research on how to detect ‘rogue’ drones near airports. The FAA will join forces with other government agencies and academic partners...more

Second Circuit Applies Stricter Rules for a Plan Administrator’s Noncompliance with Benefit Claims Regulations

In Depth - On April 12, 2016, the US Court of Appeals for the Second Circuit in Halo v. Yale Health Plan, 2016 WL 1426291 (2d Cir. Apr. 12, 2016), addressed various issues that could arise during a plan administrator’s...more

Cutting Through the Constitutionality Haze in the Battle Between PHH Corporation and the Consumer Financial Protection Bureau

So much has been written in recent weeks about the battle between PHH Corporation and the Consumer Financial Protection Bureau in the U.S. Court of Appeals for the D.C. Circuit. The panel heard oral argument on April 12,...more

Employers May See Higher OSHA Fines Sooner than Expected

August 1, 2016, is the effective date for imposition of higher fines by the Occupational Safety and Health Administration, but violations alleged in inspections occurring as recently as this February may be subject to the...more

Recent Decision Underscores the Importance of Keeping Detailed and Accurate Daily Logs

The Armed Services Board of Contract Appeals’ (ASBCA) recent decision in Dick Pacific Constr. Co., Ltd, serves as an important reminder to federal construction contractors that keeping consistent and detailed daily logs is...more

Mine Accident Investigation Facts Not Subject to Attorney Privileges, ALJ Rules

According to at least one administrative law judge, neither the work product privilege nor the attorney-client privilege allows an Arizona metal producer and its contractor to withhold factual information gathered during the...more

USPTO 101 Guidance: Microneedles Versus Prosthetic Devices

When I first wrote about the new natural products Subject Matter Eligibility Examples issued by the USPTO on May 4, 2016, I noted a puzzling difference between the treatment of a claim reciting a vaccine coated on a...more

FERC Grants Extension of Time for Natural Gas Storage Company to Construct Expansion Facilities Over More Than 250 Comments in...

On May 16, 2016, the Federal Energy Regulatory Commission granted Arlington Storage Company, LLC (Arlington) a two-year extension of time to construct a previously authorized underground natural gas storage expansion project....more

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

Did The SEC Staff Bypass The APA In Issuing New And Revised Non-GAAP Financial Measure C&DIs?

Earlier this week, the staff of the SEC’s Division of Corporation Finance issued several new, and rewrote several existing, Compliance and Disclosure Interpretations (“C&DIs”) relating to Non-GAAP Financial Measures. ...more

Oakland’s New Medical Cannabis Regulations

On May 17, 2016, the Oakland City Council approved new detailed regulations intended to mainstream medical cannabis retail and commercial operations and pave the way for the City to accept cannabis business permit...more

Judge Uses Institution of IPR to “Bolster” Decision to Overturn Jury’s Finding of Willfulness

A Colorado district court has provided an example of how the decisions of the PTAB in an IPR proceeding can impact district court litigation. In XY, LLC v. Trans Ova Genetics, LLC, Case No. 1:13-cv-00876 (D. Colo.), Judge...more

In re Certain Activity Tracking Devices, Systems, and Components Thereof

Pepys (17th century) recorded his sleep patterns, so wearable devices that record sleep patterns unpatentable? On April 27, 2016, the U.S. International Trade Commission (ITC) issued an Order indicating that two patents...more

Intellectual Property Bulletin - Spring 2016

Supreme Court to Weigh In on Damages for Design Patent Infringement - Recent decisions from the U.S. Court of Appeals for the Federal Circuit regarding damages available in design patent cases highlight the court’s...more

FDA Talks Generic Drugs: A Look at the Generic Drug Approval Process from the Agency’s Perspective

So you’re preparing an abbreviated new drug application submission… what could possibly go wrong? The Food and Drug Administration responds: Let us count the ways… However, much of it can be avoided if one merely knows where...more

California Telecom Providers File Suit to Protect Competitively Sensitive Information

On May 5, AT&T Mobility along with several other telecommunications providers and trade associations filed a complaint in the Northern District of California against the California Public Utilities Commission (“CPUC”)...more

FDA Releases (an Updated) Guidance on Medical Foods: What They Are, And What They Are Not

The Food and Drug Administration recently released its Second Edition of its “Guidance for Industry: Frequently Asked Questions About Medical Foods.” The newer version updates previous guidance and provides responses to...more

The McDonald’s NLRB Case: At The Intersection Of Hot Legal And Political Issues

Despite popular belief, the fate of fast food franchises around the country does not rest in the hands of Lauren Esposito, an unelected administrative judge for the National Labor Relations Board (NLRB). Whatever decision...more

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