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Justice Department Seeks to Shut Down Detroit Area Tax Return Preparers

The Justice Department announced today that it has asked a federal court in Detroit to permanently bar Brandon Lee and Tamika Lee, a husband and wife who do business as Quick Money Tax & tax returns in order to claim false and inflated earned income tax credits (EITC).



  • OPA Press Releases

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Justice Department Sues to Stop Florida Tax Return Preparer

The United States has asked a federal court in Tampa, Florida, to stop Octavio Cruz and his company, Advantage Accounting Corp., from preparing federal income tax returns for others, the Justice Department announced today



  • OPA Press Releases

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Justice Department Sues to Stop South Florida Tax Return Preparer Engaged in Fraud and Earned Income Credit Schemes

The United States has asked a federal court in Miami to permanently bar a South Florida man and his two Miami businesses, Ebenezer Tax Services Inc. and Primo Tax Service Inc., from preparing federal income tax returns for others, the Justice Department announced today. He is alleged to have defrauded the government out of more than $20 million



  • OPA Press Releases

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Federal Court Bars Missouri Man from Preparing Federal Tax Returns

A federal court has permanently barred William Naes of St. Charles, Missouri, from preparing federal tax returns for others, the Justice Department announced today. The permanent injunction order, to which Naes consented, was entered by U.S. District Judge E. Richard Webber of the U.S. District Court for the Eastern District of Missouri



  • OPA Press Releases

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Justice Department Sues to Stop Chicago-Area Woman and Her Businesses from Preparing Tax Returns

The United States filed a complaint in federal court in Chicago to bar Laurie G. Helfer, aka Laurie G. Powell, individually and through her businesses Laurie’s Freelance & Tax Preparation Services and Tax Lady Laurie Inc., from preparing federal tax returns for others, the Justice Department announced today



  • OPA Press Releases

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Justice Department Sues to Shut Down Mississippi Tax Return Preparer

The United States has requested that the U.S. District Court for the Northern District of Mississippi permanently bar Nathaniel Kimble, Greenville, Mississippi, man from preparing federal income tax returns for others, the Justice Department announced today.



  • OPA Press Releases

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Owner of Tax Return Preparation Franchise and Health Provider Business Sentenced to Prison for Tax Fraud, Healthcare Fraud and Money Laundering

Claude Arthur Verbal II, formerly of Raleigh, North Carolina, and now of Miami, was sentenced today to serve 135 months in prison for tax fraud, healthcare fraud and money laundering crimes in two separate cases in federal court



  • OPA Press Releases

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Federal Court Bars Louisiana Woman from Preparing Federal Tax Returns

A federal court in New Orleans has permanently barred Shawanda Nevers, of La Place, Louisiana, from preparing federal income tax returns for others, the Justice Department announced today.



  • OPA Press Releases

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Court Bars Florida Tax Return Preparer from Preparing Returns for Others

A federal district judge in the U.S. District Court for the Middle District of Florida has permanently barred Jeanne Covington, of Tampa, Florida, and her company, Jeanne’s Tax Preparation and Bookkeeping Inc., from preparing federal income tax returns for others.



  • OPA Press Releases

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DSM Insight Series: 1 in 4 Consumers Prepare, Consume Breakfast in Less Than 5 Minutes

DSM today published the first part of a new report in its Global Insight Series, focused on breakfast habits and behavior in Europe and the US.




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Preparing for Pricing in DTC TV

UPDATE 2: On August 21, 2019, the government filed a notice of appeal in this case.

UPDATE: On July 8, 2019, the judge in the pending litigation described below issued an order setting aside the CMS rule. The full opinion is available here.

If nothing changes, the new rule about including drug pricing in TV ads from CMS will go into effect one week from today on July 9, 2019.

There are a few wrinkles to keep in mind as we approach this deadline. First, there's a lawsuit pending that could delay the rule's implementation. Second, the operational challenges of abiding by the rule are the biggest hurdle including the expanded 2253 filing requirements. Third, the rule's scope is still unclear. Fourth, the rule doesn't preclude or preempt the PhRMA Principles change from April. Finally, the overlapping but non-identical scope of the rules could lead to some confusion and compliance hiccups. This post addresses each of these points in turn.

Pending Litigation

As I noted in a previous post, several pharmaceutical companies along with the Association of National Advertisers filed a complaint seeking to overturn the CMS rule. The full complaint is available here. The plaintiffs have filed a motion to stay the rule's implementation, and the judge has set a date of July 8 for issuing a decision. So, it is possible that companies will not actually be required to include their drug pricing in TV spots on July 9; however, as a practical matter, companies airing spots on July 9 and soon thereafter have most likely already developed them with the required pricing information included. 

All promotional materials for prescription drugs, biologics, and vaccines must be submitted to the FDA at time of initial dissemination or publication, so the FDA has most likely already begun receiving submissions of TV spots that include the information, and it is unlikely that a company would go to the time and expense of producing two versions of their TV spots (one with the pricing and one without) and submit both the FDA, only to determine on July 8 which spot to air the next day. Consequently, even if the judge issues a stay on the rule, there's a good chance that you'll see at least a few TV spots featuring pricing on July 9.

And that points to one of the issues the rule raises: operational challenges.

Operational Challenges 

Adding a line of copy to a TV ad is not a massive creative endeavor, and because the rule only requires the copy to appear on screen for a long enough time to be read, there are no audio implications, but the CMS rule requires that the pricing information presented is kept up to date. Specifically, the new rule requires that the pricing information provided be:
"as determined on the first day of the quarter during which the advertisement is being aired or otherwise broadcast." 42 CFR 403.1202 (not yet live on the code of federal regulations itself).

That means the pricing information must potentially be updated every quarter. Of course, most companies don't change their drug pricing quarterly, but it is common to have pricing updates twice per year. So, every time a company changes its pricing, it will have to determine what ads are currently airing and whether the pricing updates affect those ads. If the pricing changes affect the ads, then the ads will have to be updated. An updated TV ad both means an expense for the advertiser, but it also means a new 2253 filing with the FDA because updated materials must be resubmitted to the Agency.

And that means that the media buyers placing the ads will have one additional wrinkle to keep in mind as they manage the ad placements. They'll need to make sure that as new pricing comes into affect and ads are updated that the old ads are removed from the rotation, lest they be placed on CMS's naughty list.

That operational challenge is compounded by the fact that the scope of the rule is unclear, so it's not currently possible to say exactly what ads must include drug pricing.

Rule Scope Unclear

As I noted in a previous post, CMS made it clear that the requirement to include pricing does not apply to ALL direct to consumer (DTC) ads, but only to a limited subset of DTC ads. Specifically, the new requirement applies to only ads that appear on broadcast, cable, satellite, and streaming television. Unfortunately, CMS never explained what "streaming television" is. I tried to find a definition somewhere but wasn't able to do so. This matters because there are tons of DTC video ads that MIGHT be considered subject to the rule that are definitely not presented on "broadcast, cable, or satellite television."

Because of this scope unclarity, the operational challenges of managing ad inventory is compounded, and of course, companies must decide how to handle ads that are used on television when they appear in places where the pricing information is not required. It would certainly be easier to develop a version of the ad that doesn't require quarterly updates, but it also is easier to traffic fewer total ad units.

CMS Rule Adds to (Doesn't Replace) PhRMA's Pricing Requirements

The Pharmaceutical Research and Manufacturers of America (PhRMA) updated its Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines in October of 2018. The most significant change was the addition of a requirement for television ads to include a destination where people can find pricing information about the prescription drug being advertised. This requirement became operative in April of 2019. All members of PhRMA are obligated to follow the PhRMA guiding principles, and most companies that are not members of PhRMA also abide by the guiding principles. Consequently, almost all television commercials currently airing include a link to a webpage with pricing information.

Adhering to the CMS rule does NOT meet the PhRMA guiding principles. Consequently, most companies will be providing both a link to a page with additional information and the pricing information required by CMS. We'll see how companies execute this, but my expectation is that a single screen at the end of a television commercial will accommodate both pieces of information.

Of course, not all ads are required to include both pieces (or even either piece!) of information.

Non-identical Overlapping Scopes

The new CMS rule applies to all advertised indications of a pharmaceutical product that are reimbursed via Medicare or Medicaid and whose cost is at least $35 per month (or for a typical course of treatment). 42 CFR 403.1200. Note that some drugs have multiple indications, where only some of the indications are reimbursed by CMS. For those products, only the ads that promote an indication reimbursed by CMS are required to include the pricing information; and only if the drug's list price is at least $35 per month (or for a typical course of treatment).

By contrast, the PhRMA guiding principles apply to all ads for prescription medicines regardless of whether the drug is reimbursed by CMS and regardless of the cost. Of course, the guiding principles are only binding on members of PhRMA and any non-member companies that have chosen to abide by the guiding principles.

TL;DR

Some commercials (but we don't know exactly which ones) might start having pricing information in one week. The addition of this information is allegedly going to address the allegedly high price of prescription drugs. The only guaranteed aspect of the recent changes from PhRMA and CMS is that marketing and regulatory operations groups are going to have challenges ensuring ongoing compliance, and the FDA is about to start getting more 2253 filings, including a likely surge of revised television spots in the next few days.




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Despite sales bump, brands that are not preparing for stormy seas ahead could struggle, consultant says

The dietary supplement industry as a whole is enjoying booming sales as consumer stock up on products to support optimum health. But an industry strategist warns that that sales bump is likely to be ephemeral, and brands that are not strategizing vigorously now may be caught out in the near future.




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Editorial: California was ready for a recession, but nothing could have prepared it for coronavirus

The good news: The state is far better prepared to meet this challenge than it was a decade ago. The bad news: It will need help from the feds, and a lot of it.




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HHS Broadly Interprets PREP Act Immunity: Reasonable Belief is Good Enough

By Anne K. Walsh



  • COVID19
  • Prescription Drugs and Biologics

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ASEAN banks prepare for flood of bad loans amid coronavirus havoc




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Bank Exam Preparation Tips 2020 at Home: IBPS PO, IBPS Clerk, IBPS RRB, SBI Clerk, RBI, LIC

Bank Exams Preparation Tips 2020: Have a look at important Tips and Strategies for bank exam preparation to fetch recruitment in banks as PO/Clerk/SO. Know details of SBI Clerk 2020, IBPS RRB 2020, IBPS PO 2020, IBPS Clerk 2020, RBI Assistant 2020, LIC AAO/ADO 2020 and other bank exams. 




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California NICU disaster preparedness




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How swamped preprint servers are blocking bad coronavirus research




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All that’s fit to preprint




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We Must Prepare for the Next Pandemic

Bruce Schneier explains why accurate information will be just as important as effective treatments when the next pandemic strikes.




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We Must Prepare for the Next Pandemic

Bruce Schneier explains why accurate information will be just as important as effective treatments when the next pandemic strikes.




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We Must Prepare for the Next Pandemic

Bruce Schneier explains why accurate information will be just as important as effective treatments when the next pandemic strikes.




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We Must Prepare for the Next Pandemic

Bruce Schneier explains why accurate information will be just as important as effective treatments when the next pandemic strikes.




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COVID-19 and military readiness: Preparing for the long game

With the saga over the U.S.S. Teddy Roosevelt aircraft carrier starting to fade from the headlines, a larger question about the American armed forces and COVID-19 remains. How will we keep our military combat-ready, and thus fully capable of deterrence globally, until a vaccine is available to our troops? It will also be crucial to…

       




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We Must Prepare for the Next Pandemic

Bruce Schneier explains why accurate information will be just as important as effective treatments when the next pandemic strikes.




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COVID-19 and military readiness: Preparing for the long game

With the saga over the U.S.S. Teddy Roosevelt aircraft carrier starting to fade from the headlines, a larger question about the American armed forces and COVID-19 remains. How will we keep our military combat-ready, and thus fully capable of deterrence globally, until a vaccine is available to our troops? It will also be crucial to…

       




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Why local governments should prepare for the fiscal effects of a dwindling coal industry

       




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WEBINAR – Are state and local governments prepared for the next recession?

During the Great Recession, cities and states saw revenue declines and expenditure increases. This led to record levels of fiscal stress resulting in service cuts, deferred maintenance of infrastructure, and reduced payments to pensions and other liabilities. This webinar will focus on how state and local governments can adopt best practices and strategies now in…

       




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A New Goal for America’s High Schools: College Preparation for All

INTRODUCTION

Economic inequality has been on the rise in America for more than three decades. The nation’s traditional engine for promoting equality and opportunity—its public education system—has been unable to halt that upward trend despite increased public spending at the preschool, K–12, and postsecondary levels. Meanwhile, accumulating research evidence reveals that postsecondary education has, for the past few decades, proved an increasingly powerful tool in boosting the income and economic mobility of disadvantaged students. Here we outline steps that high schools can take to increase the college readiness of poor and minority students, making it more likely that they will be accepted into and graduate from college.

The annual income difference between Americans with a college degree and those with a high school degree was more than $33,000 in 2007, up from $12,500 in 1965. More to the point, long-term intergenerational data from the Panel Study of Income Dynamics show that a college degree helps disadvantaged children move up the income distribution past peers in their own generation. Adult children with parents in the bottom fifth of income, for example, nearly quadruple (from 5 percent to 19 percent) their chance of moving all the way to the top fifth by earning a college degree.

But too few poor kids get a college degree. About one-third of all youngsters from the bottom fifth of family income enter college and only 11 percent get a degree. By contrast, 80 percent of those from the top fifth enter college and well over half earn a degree.

Perhaps the primary reason that poor and minority students do not enter and graduate from college is that they are poorly prepared to do well there. The problem is especially evident in the huge gap between the academic achievement of white, Asian, and middle- and upper-income students as compared with black, Hispanic, and low-income students. And decades of educational reform aimed at reducing this gap have had, at best, modest success. Striking evidence of how few college freshmen meet even the most basic college preparation standards is provided by Jay Greene and Greg Forster of the Manhattan Institute. Defining minimum college readiness as receiving a high school diploma, taking courses required by colleges for basic academic preparedness, and demonstrating basic literacy skills, Greene and Forster report that only around 40 percent of white and Asian students were college ready by these criteria. But that figure was twice the 20 percent rate for black students and more than twice the 16 percent rate for Hispanic students.

The latest issue of The Future of Children, devoted to exploring how to improve America’s high schools, contains several articles that touch on student preparation for postsecondary education and the world of work. An especially compelling article, written by Melissa Roderick, Jenny Nagaoka, and Vanessa Coca, of the Consortium on Chicago School Research at the University of Chicago, contains a careful analysis of how to measure whether students are ready for college and a host of proposals for actions high schools can take to increase their students’ readiness for postsecondary education. As the Roderick article and related research and analysis make clear, recent years have seen an upsurge of support for the goal of helping all students, but especially poor, urban, and minority students, prepare for college, enter college, and earn a terminal degree. Attaining that goal, we believe, would boost economic mobility in the United States and help the nation live up to its ideals of equality of educational and economic opportunity.

Downloads

Authors

Publication: The Future of Children
     
 
 




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We should prepare now to send US armed forces to help police in hard-hit areas

Already, the U.S. armed forces are providing important help here at home in the struggle against the novel coronavirus. Well over 10,000 members of the Army National Guard and Air Force National Guard have been mobilized to help with setting up more hospital capacity, transporting supplies and providing other services. Other personnel who have “Individual Ready Reserve” status are being…

       




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Korean Reunification and U.S. Interests: Preparing for One Korea

 

      
 
 




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Preparing the United States for the superpower marathon with China

Executive summary The U.S. is not prepared for the superpower marathon with China — an economic and technology race likely to last multiple generations. If we are to prevail, we must compete with rather than contain China. While this competition has many dimensions — political, military, diplomatic, and ideological — the crux of the competition…

       




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Why local governments should prepare for the fiscal effects of a dwindling coal industry

       




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COVID-19 outbreak highlights critical gaps in school emergency preparedness

The COVID-19 epidemic sweeping the globe has affected millions of students, whose school closures have more often than not caught them, their teachers, and families by surprise. For some, it means missing class altogether, while others are trialing online learning—often facing difficulties with online connections, as well as motivational and psychosocial well-being challenges. These problems…

       




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Be Ready for Anything with Take Out Furniture, it's Perfect For Preppers

Clever idea from Finnish designer combines portable storage with fixed dresser unit




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7 ways to prepare delicious kohlrabi

Sometimes the most boring vegetables are the most versatile.




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How to prepare for a quarantine

From what food to buy to how to access your medical records, here are the practical matters to consider before a pandemic strikes.




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How to prepare houseplants for fall

WIth cooler weather and shorter days, your indoor plants could use a little help getting ready for the new season.




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Prepare for the rise of robotic pets

An animal welfare researcher says the prospect of robopets is not as far-fetched as we may think, and may have potential impact on how we view actual animals.




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Coastal flooding could cost $1 trillion by 2050, as Task Force warns to prepare for future storms

We've long known that sea level rise caused by global warming would threaten communities along the coasts, but a new study puts a startling figure on the potential damage. Meanwhile, the Hurricane Sandy Task Force releases a report.




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President Obama establishes a climate change preparedness and resilience task force

Today, President Obama signed an Executive Order (E.O.) establishing a Task Force on Climate Preparedness and Resilience.




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T. Rowe Price: Boys And Girls Not Equally Prepared For Financial Future - T. Rowe Price Survey Key Findings

T. Rowe Price Survey Key Findings




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What happens when planning and preparation pay off at a time when you need it the most? - John Peden - #NMClientStory

John Peden - #NMClientStory




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Remote Island in the Philippines watches the Pacquiao-Mayweather fight live for the first time - Preparations on Bantayan island

Preparations for a live screening of the Fight of the Century on a remote island in the Philippines





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Be Prepared: Campuses Today Are Training Future Financial Planners for the Real World - Closing Bell Opens Doors for Students

Closing Bell Opens Doors for Students




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Ready for Blast-Off: Lockheed Martin Launches Educational Program to Prepare America's Students for Deep Space Exploration - Students Travel to Mars

These students think they are boarding an ordinary school bus, but when they depart, a virtual reality experience “transports” them to the surface of Mars.




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FEMA, NWS Urge Families and Communities to Take Steps to Prepare for Hazards - Get Prepared with Bo and Sunny

Get Prepared with Bo and Sunny. Links to download these videos can be found in the Resources section, below.




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Informe reciente resalta la necesidad de concentrarse más en que las familias planifiquen para estar preparadas - Waiting 30 Seconds Spanish

Waiting 30 Seconds Spanish




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La OEM, la FEMA, y el Ad Council dan inicio a la undécima versión anual del Mes Nacional de la Preparación en la ciudad de Nueva York - Waiting- NYC Spanish :30

Asegúrese que su familia tenga un punto de reunión para encontrarse en casos de emergencia. Visite N-Y-C punto gov diagonal ready N-Y o marque 311.