Administrative Agency Updates

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Highmark and UPMC Consent Decree

Highmark and UPMC took a major step toward resolving network participation issues June 27, 2014, by executing a Consent Decree with the Commonwealth of Pennsylvania Departments of Insurance and Health. The Consent Decree...more

FDA Issues 510(k)/Substantial Equivalence Draft Guidance Describes Benefit-Risk Factors Considered for New 510(k) Devices with...

On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance document titled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)]with Different...more

FDA Accepts First Biosimilar Application under New Approval Pathway

July 24, 2014 was a landmark day in the biotechnology industry: Sandoz (the generic arm of Novartis) announced that the U.S. Food and Drug Administration (FDA or “the Agency”) had accepted the first application for a U.S....more

Untamed Skies: Domestic Drones Remain Unregulated

What once was a technology confined almost exclusively to military use has now made its way into the hands of businesses, domestic agencies and private hobbyists. Small, Unmanned Aerial Vehicles (or UAVs), more commonly known...more

Finally, A Biosimilar Application Has Been Accepted By The FDA

In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more

Guns and More Guns: SEC Hits Smith & Wesson for FCPA Violations

One thing the SEC likes to do is bring cases with a lot of deterrent value. That is, cases that it hopes will scare other people and companies into complying with the law. Often that means cases with large price tags...more

ITC Section 337 Update – July 2014

Commission Affirms No Domestic Industry Based On Research And Development In 859 Investigation – On July 21, 2014, the Commission issued a Notice To Affirm In Part, Reverse In Part And Vacate In Part The Final Initial...more

Favorable Ruling: Taxability of HMOs Under New York City General Corporation Tax

A New York City Tax Appeals Tribunal Administrative Law Judge (ALJ) recently ruled in favor of Aetna, Inc. (Aetna) on whether a health maintenance organization (HMO) was “doing an insurance business” in New York State,...more

Court Slams Medicare Agency, Notes Reputation As “Unfeeling Bureaucracy”

The Department of Health & Human Services’ Provider Reimbursement Review Board (Board) came in for some withering criticism last Friday from the federal court hearing the appeal of University of Chicago Hospital from the...more

CRA Required to Reassess in Accordance with Terms of Settlement

The recent decision in Bolton Steel Tube Co. Ltd. v. The Queen, 2014 TCC 94, confirms that the CRA is required to reassess a taxpayer in accordance with terms of settlement. In its decision, the Tax Court provides useful...more

New Mexico Hearing Examiner Confirms October Hearing on PNM Application to Abandon San Juan ?Generating Stations Unit 2 and 3 ?

Earlier this month, Public Service Company of New Mexico (PNM) filed a notice of the status of negotiations among the San Juan Generating Station (SJGS) participants relating to the ownership restructuring of SJGS plants 1...more

Texas Court of Appeals Holds There is No Right Under The Administrative Procedure Act to Seek Judicial Review of a State Agency's...

On July 23, 2014, the Austin Court of Appeals held that Texas trial courts lack subject matter jurisdiction under the Texas Administrative Procedure Act (APA) to review orders by state agencies denying petitions for...more

The FDA’s Informed Consent Draft Guidance: Insights and Challenges for IRBs, Clinical Investigators and Sponsors

On July 15, 2014, the FDA released a draft guidance document (“Guidance”), proposing recommendations to Institutional Review Boards (IRBs), clinical investigators and research sponsors relating to the informed consent process...more

Shorts on Long Term Care - Summer 2014

In this issue: - Nursing Facility Survey Trends: Directed Plans of Correction, Privacy Violations and FTag 520 Quality Assurance Committee Citations - COBRA Meets ACA – Time to Update COBRA Notices -...more

Hospitals File Lawsuit Over Medicare ALJ Hearings Delays

Over 460,000 appeals requesting hearings before an administrative law judge (ALJ) were pending in the Office of Medicare Hearings and Appeals (OMHA) at the end of 2013, with 15,000 new appeals being submitted each week. At...more

NLRB Strikes Down Hospital's Rule Prohibiting Negativity and Gossip Among Employees

In its continuing trend to foray into non-union workplaces, the National Labor Relations Board (“NLRB” or the “Board”) struck down another neutral and common employment policy. On April 1, 2014, in Hills and Dales Gen....more

Missouri DOR Burden of Proof and Notice Requirements Remain Uncertain After Veto

The Missouri General Assembly passed several tax-related bills at the end of the legislative session in mid-May that would have altered the Department of Revenue’s (Department) burden of proof and changed its notice...more

IPR Spotlight Series: What to Do When the PTAB Denies Your Petition to Institute IPR

Inter partes review (IPR) before the Patent Trial and Appeal Board (PTAB) became available on September 16, 2012 as a post-grant review procedure to challenge the patentability of issued claims based on prior art patents and...more

Drugs and the Internet: draft guidance on social media platforms and prescription drugs

The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more

Recent FDA Draft Guidance Addresses Social Media Challenges Faced by Drug and Device Companies

The first draft guidance discusses how drug and medical device companies may promote their products using character space limited social media (e.g., Twitter) and Internet advertisements (e.g., Google search engine...more

FDA Accepts the First Biosimilar Application under the BPCIA

Sandoz announced yesterday that the FDA accepted its Biologics License Application (BLA) for filgrastim. This marks the first acceptance of a biosimilars application (351(k)) filed under the pathway created by the Biologics...more

New Washington Rule Clarifies Authority to Issue Penalties Against TPAs

The Washington State Department of Health has promulgated a new rule clarifying the Department's authority to issue civil penalties against health carriers and third-party administrators. This rule, which is outside the...more

Reality Check on the Auditor General’s Report on DEP’s Oversight of Oil and Gas Operations

The expected chorus of politically driven indignation is raining down in response to the Auditor General’s report released this Tuesday on the DEP’s performance in monitoring potential impacts to water quality from shale gas...more

EPA Re-gains “Green Light” to Regulate Permitting Procedures - D.C. Circuit overturns lower court decisions on EPA permitting...

Two district court orders declaring the federal Environmental Protection Agency acted illegally when it implemented certain permitting procedures for coal mining operations have been vacated by a federal court of appeals....more

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

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