Monthly Archives: August 2012

FDA Approval is Never Enough

The following may surprise some: FDA approval or clearance is never enough. Not if manufacturers want a commercially successful product. There is no doubt that addressing FDA issues is critical. But without data to show effectiveness, payers will not reimburse a particular product or technology—and even the most promising product will languish in the market without the appropriate coverage and reimbursement.

The use of remote monitoring devices has increased significantly over the last few years. I think it is fair to say that many manufacturers of these devices worry far more about FDA clearance and approval issues than they do about coverage and reimbursement. And that is a critical mistake. Clearing FDA hurdles is surely an important step but without a sophisticated coverage and reimbursement strategy, a product has almost no chance of market success. So, why do many manufacturers and other stakeholders not prioritize coverage and reimbursement as part of product launch strategy? Part of the answer lies in the complex, often confusing rules and policies many payers (both public and private) have in place. For example, just to look at a few:

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Climate Change Science: Trial Courts And Regulations

Overlooked in the District of Columbia U.S. Court of Appeals decision, dated June 26, 2012, in Coalition for Responsible Regulation, Inc. v. EPA, is the court’s discussion of the climate change science relied upon by EPA. The decision unanimously upholds EPA’s determination that greenhouse gases, such as carbon dioxide, endanger public health and likely have been responsible for global warming over the past half century. The coal industry brought suit against EPA arguing that it had overstepped its jurisdiction under the Clean Air Act and acted without having an appropriate scientific basis for its actions. (Interestingly, several of the utilities among the Petitioner members had earlier argued the opposite during the Supreme Court argument in AEP v. Connecticut, where they sought dismissal on the ground that the EPA had the authority to regulate greenhouse gases under the Clean Air Act.)

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Unsurprising Results from OSHA’s Recordkeeping NEP

By Eric J. Conn, Head of the OSHA Practice Group

According to a recent report to Congress from OSHA, the Agency’s multi-year Injury & Illness Recordkeeping National Emphasis Program (“Recordkeeping NEP”) continued through its termination in 2012 to yield less alarming results than the OSHA leadership team forecasted, despite revising the program in late 2010.

The initial version of the Recordkeeping NEP was put on hold due to lower than expected (at least by OSHA) instances of recordkeeping abuses (i.e., employers deliberately under recording injuries and illnesses), so OSHA attempted to modify the targets of the Recordkeeping NEP to smoke out the bad actors that OSHA believed were out there in droves.  The revised Recordkeeping NEP, however, identified even less under-recording per inspection than did the original version of the NEP.

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Week of August 20, 2012 on ILNToday – A Roundup

With all the content that’s being published, you’d hardly know that it was one of the biggest months for holidays! Here are this week’s top posts from ILNToday:

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ILN Today Post

Tax Law Bulletin

AMENDMENTS TO BILATERAL DOUBLE TAX TREATIES

According to Ministry of Finance announcements, many of the bilateral double tax treaties (“DTTs”) concluded by Poland are being renegotiated. As many as 4 protocols amending the current DTTs have been signed so far in 2012, i.e. with Cyprus, Iceland, Luxembourg and Norway. Those currently in force between Poland – Czech Republic and Poland- Canada will be replaced by new ones. More…

 

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ILN Today Post

Trust investment disputes

In this article we look at some of the issues concerning trustees and beneficiaries where a complaint is made about the performance of trust investments.

In recent years in particular, trustees will be excused for having had many sleepless nights, lying awake asking themselves such questions as:

  • Is my fund exposed to any of the reported $50bn losses in Bernie Madoff’s Ponzi scheme?
  • How much of the decline in global stock markets – $32trn from their 2007 peaks to mid 2009 – are in my fund?
  • Does my fund have exposure to the $50trn market in CDOs that has now blown up with such spectacular effect? More…
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ILN Today Post

New requirements for transaction passport formalization are adopted

The Central Bank of the Russian Federation adopted Instruction as of the 4th June, 2012 No.1238-I “On order of submission by residents and nonresidents to authorized banks of documents and information relative to conducting of currency operations, order of transaction passport formalization as well as order of currency operations’ registration by authorized banks and control for their execution” (hereinafter, «Instruction»).

The Instruction provides updated set of requirements to formalization of international transaction passport (hereinafter, “TP”), which is one of the primary measures of currency control in the Russian Federation; it was elaborated by the Central Bank of the Russian  Federation further to provisions set out in section 1, article 20 of the Federal Law “On currency regulation and currency control” No 173-FZ, and is supposed to substitute the current instruction of the Bank of Russia as of the 15th June, 2004 No 117-I, as well as row of other normative acts of the Bank of Russia regulating issues of transaction passports formalization. More…

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ILN Today Post

Beware the perils of advertising via social media

The Australian Advertising Standards Bureau’s (ASB) recent determination that a business’ Facebook page can operate as an advertisement has far reaching implications for the management of business risk generally. This decision illustrates what marketing has known for some time – social media tools are not necessarily just a method of networking or communicating with consumers.  Such use can legally amount to advertising.

The determination followed an investigation of a complaint made about various comments and photographs uploaded by Smirnoff, and members of the Smirnoff Facebook community, onto a Smirnoff Facebook page. More…

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Blogging for Clients: How Online Relationships Lead to Real-World Clients (A Re-cap) Part II

On Tuesday, we jumped into the first half of Kevin McKeown and Lee Frederiksen’s webinar on Blogging for Clients. Today, we’re looking at the second half!

Developing your Strategy and Tools

Lee said that when you look at online marketing at a macro level, there’s not one technique that says “this is the one to use.” There are a whole bunch of techniques. So how do these fit together – how do you make sense out of this about what you need to do, and when you need to do it? 

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No-fault compensation scheme proposed for NHS claims

A recent consultation launched by the Scottish Government is seeking views from interested parties on proposals to introduce a no-fault compensation scheme for NHS claims in Scotland.

The proposals are based on recommendations made by an independent panel, the No-Fault Compensation Review Group, which was set up by the Health Secretary in 2009.

The Review Group’s report was published in February 2011 and recommended that the Government should consider establishing a no-fault scheme that would cover all clinical treatment injury, similar to the ‘no blame’ system in operation in Sweden.

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