Category: Administrative & Regulatory

Ebola Response Missing A Critical Player

Covington BUrling Law Firm

The Obama Administration has mobilized a number of government agencies to respond to the Ebola crisis in West Africa and to prevent its spread into the U.S. At the frontline of the Administration’s response is the Pentagon, the Department of Health and Human Services, the Center for Disease Control, the U.S. Agency for International development and, more recently, the Department of Transportation.

Conspicuously missing, however, is the Department of Commerce, which traditionally is the link to the U.S. private sector.

This omission is significant because U.S. companies are likely to get materials to the stricken countries of Liberia, Sierra Leone and Guinea more quickly than the Pentagon.  In the instances in which they operate locally, the companies provide a valuable source of information and delivery infrastructure.

For example, in mid-August, more than 20 leading medical companies shipped 40 tons of supplies and protective equipment to Liberia.  The airlift was coordinated  by the California-based NGO, Direct Relief, and facilitated by Fedex. Companies such as Pfizer, Teva, Merck, Kimberly-Clark and Mylan Laboratories contributed 2.3 million gloves, 65,000 masks and 185,000 tabs of antibiotics. As of September 20th, Direct Relief had coordinated 11 shipments of supplies.

Equally important is the Ebola Private Sector Mobilization Group (EPSMG) which is a network of more than 40 companies active in West Africa and, especially, Liberia, Guinea and Sierra Leone. Chaired by ArcelorMittal and including companies such as Chevron, Rio Tinto and BHP Billiton, the group seeks to provide a single access point for the private sector to help mobilize and coordinate a response.  The group’s first principal is to “be part of the region’s long-term economic and social recovery and development.” EPSMG has met with Dr. Margaret Chan, Director General of the World Health Organization, and the U.S. ambassador to Liberia, Deborah Malac, and engaged with organizations such as the UN Ebola Task Force, the World Bank and various NGOs.

The in-country private sector plays other important roles.  ArcelorMittal, which has a workforce of nearly 3000, provides health care for its workers and their families and uses its internal communications network to convey accurate and timely information about the epidemic.  Firestone Rubber, which has been in Liberia since 1926, detected in first case of Ebola on March 30th, according to NPR. Since then, the company went into crisis mode, built its own treatment center and developed a comprehensive response that effectively stopped the transmission of the virus among more than 80,000 employees and family members who live on the sprawling plantation.

Local companies such as the National Oil Company of Liberia and the Sierra Leone Produce Marketing Company have also made contributions to combatting the virus.

The importance of the private sector’s role in responding to health emergencies cannot be underestimated.  Companies such as Anglo-American, SABMiller and Ford Motor Company played critical roles in combatting the HIV/AIDS crisis in South Africa by making medicines and quality health care available to their employees and their families, and they continue to play this role.

The U.S. Chamber of Commerce and the Corporate Council on Africa are to be applauded for the role that they have played in helping to coordinate and publicize the U.S. private sector response to the Ebola crises.

The Obama Administration has effectively integrated the private sector into key development initiatives such as Power Africa and the New Alliance for Food Security and Nutrition, which is the private sector component of Feed the Future.  It would do well to establish a similar mechanism as part of its Ebola response. Controlling the spread of Ebola and the development of viable health care systems in the three affected countries will require the sustained engagement of governments, NGOs, international organizations and agencies and the private sector.  The sooner that all parties are able to coordinate their efforts the more likely this virus will be controlled.

© 2014 Covington & Burling LLP
ARTICLE BY

Witney Schneidman
OF
Covington & Burling LLP

November Visa Bulletin Confirms Fears of Significant Retrogression for EB-2 India

Greenberg Traurig Law firm

The Department of State released its November Visa Bulletin today. It is a mixture of good news and really bad news. The good news is that the EB-2 and EB-3 categories for all countries, except for India, continue to experience forward movement. Worldwide, EB-2 availability remains current and EB-3 availability advanced to June 1, 2012. China also experienced forward movement, with EB-2 advancing to December 8, 2009, and EB-3 advancing to January 1, 2010.

The really bad news in the Visa Bulletin relates to visa availability for India. As expected, EB-2 availability for India retrogressed by more than four years, from May 1, 2009, to February 15, 2005. EB-3, however, advanced by one week to November 22, 2003.

The Visa Bulletin also contains projections for future months. Visa availability in the EB-1 (all countries) and EB-2 (worldwide) categories are expected to remain current over the coming months. EB-3 worldwide availability is expected to experience rapid forward movement for the next several months. For China, EB-2 availability is projected to increase by three to five weeks per month, and rapid forward movement is also expected in the EB-3 category, with potential retrogression in February. India is not expected to have any forward movement in the EB-2 or EB-3 categories.

In short, individuals from India face a bleak outlook in green card availability over the next few months, while the future is brighter for individuals from all other countries.

EB   Category

Worldwide

China

India

EB-1

Current

Current

Current

EB-2

Current

12/08/2009

02/15/2005

EB-3

06/01/2012

01/01/2010

11/22/2003
©2014 Greenberg Traurig, LLP. All rights reserved.
ARTICLE BY

Scott T. Decker
OF
Greenberg Traurig, LLP

Reclassification of Hydrocodone Takes Effect This Week

McBrayer NEW logo 1-10-13

The U.S. Drug Enforcement Administration (“DEA”) published a Final Rule on August 22, 2014, which elevates hydrocodone-combination products (“HCPs”) to a Schedule II category of drugs under the Controlled Substances Act. That rule becomes effective this week – on October 6, 2014. While some hydrocodone products are already listed as Schedule II, some combination products (such as Vicodin, Norco, and Tussionex) were previously listed on the less-restrictive Schedule III. In determining whether rescheduling was necessary, the DEA considered multiple factors including the potential for abuse, likelihood of dependence, and the threat to public health posed by the drug.

How does the new rule affect prescribers?

According to DEA, HCPs prescriptions issued prior to October 6, 2014 and authorized to be filled or refilled may be dispensed if such dispensing occurs before April 8, 2015. In some cases, pharmacy dispensing software products may not be able to process existing refills starting on October 6, or pharmacies may simply choose not to dispense refills after the effective date.

Pursuant to the Final Rule, HCPs prescriptions written on or after October 6, may not be refilled. No refills are allowed by any practitioner for Schedule II controlled substances and Schedule II prescriptions may only be given for maximum of a 30-day supply. Commentators to the proposed rule worried that rescheduling would result in more trips to the doctor to receive appropriate pain control. In response to these concerns, the DEA noted in the Final Rule that prescribers may issue multiple prescriptions authorizing patients to receive up to a 90-day supply, provided certain regulatory requirements (established in 21 CFR 1306.12) are met.

Prescription Bottle of Pills Spilled on Table

In addition, in Kentucky, Schedule II controlled substance prescriptions may not be faxed or called in to a pharmacy except as provided for in 902 KAR 55:095. Schedule II controlled substance prescriptions that are electronically prescribed must use a system that has been audited for compliance with the regulations specified in 21 CFR 1311. Further, Schedule II controlled substance prescriptions are valid for 60 days from the date written and controlled substance prescriptions must be signed and dated on the date issued by the prescriber.

Kentucky prescribers should be aware that restrictions on prescribing existing Schedule II pure hydrocodone products remain under current Kentucky statutes and regulations because these products were not rescheduled to Schedule II.

Midlevel providers who operate under collaborative agreements or are limited in their ability to prescribe certain Schedules of medications may be particularly affected by the Final Rule. In Kentucky, KRS 314.011, Section 8 (a) limits APRN prescribing of Schedule II controlled substances to a 72 hour supply with no refills, except certified psychiatric-mental health nurses are permitted to prescribe up to a 30-day supply of a Schedule II psychostimulant with no refills. KRS 314.011, Section 8 (b) limits APRN prescribing of Schedule III controlled substances to a 30-day supply with no refills. Because KRS 314.011, Section 8 (b) was in effect March 19, 2013, all APRNs will continue to be permitted to prescribe a 30-day supply of Schedule II hydrocodone combination products if allowed under their DEA license.

Even if the Final Rule does not specifically affect a prescriber’s abilities, prescribers should be prepared to work with pharmacies in order to minimize dispensing disruptions after the effective date. They should also identify and inform patients who are currently receiving HCPs about the rescheduling and, if necessary, discuss alternative pain management options. And, as prescribers well know, any new regulatory framework also brings with it the expectation of greater scrutiny and oversight in the future from regulatory authorities and law enforcement agencies.

ARTICLE BY

Christopher J. Shaughnessy
OF
McBrayer, McGinnis, Leslie and Kirkland, PLLC

Where do Social Security Payments Made by Undocumented Workers Go?

Greenberg Traurig Law firm

Many employers are familiar with the following scenario: You hire someone, put them on payroll and deduct taxes from their checks automatically – just like you do with all employees. You then find out through an audit by U.S. Immigration Customs and Enforcement (ICE) or by the employee coming clean that he or she is using a fake social security number. You consequently terminate employment on the grounds that they violated the company’s “honesty policy” or simply because he or she is not authorized to work in the United States. So what does Social Security do with the payments that the employee has made?

According to the Social Security Administration (SSA) unauthorized workers are paying an estimated $13 billion per year in social security taxes and are receiving about $1 billion in return. During an interview, Stephen Goss, the chief actuary of the SSA, estimated that there are approximately 11 million undocumented people in the United States and about 7 million of these people are working illegally. Further, out of these 7 million undocumented workers, approximately 3.1 million people are using fake or expired social security numbers. Goss noted that undocumented workers have paid around $100 billion in social security taxes over the last decade, which the SSA has treated as a positive cash flow without a home. Goss indicated that the $100 billion in unclaimed social security created by undocumented workers has been a key factor in allowing the SSA “to be paying benefits for as long as it now can.”

So, and in answering the headline question, the SSA puts all of these “homeless” contributions into the Social Security Trust Fund for Old-Age and Survivors Insurance (OSAI). This fund is used to ultimately pay out social security benefits to U.S. workers and retirees.

ARTICLE BY

Ian R. Macdonald
OF
Greenberg Traurig, LLP

House Passes Bill to Prevent EPA Overreach

Varnum LLP

The U.S. House of Representatives recently passed legislation prohibiting the U.S. Army Corps of Engineers and the Environmental Protection Agency (EPA) from developing, finalizing, adopting, implementing, applying, administering, or enforcing the EPA rule defining what constitutes “waters of the United States” under the Clean Water Act.

This Waters of the United States Regulatory Overreach Protection Act of 2014, H.R. 5078, comes as a response to a move by the EPA in April of this year that proposed changes to how the EPA will define “waters of the United States.” The EPA’s update uses scientific terms from hydrogeology to define which waters are covered under the Clean Water Act.

Farmers, however, have criticized the EPA update as 80 pages of technical and legal jargon. After Congressional hearings, the House passed The Waters of the United States Regulatory Overreach Protection Act of 2014. This bill will go to the Senate next for consideration.

ARTICLE BY

Aaron M. Phelps
Sherry X. Lin
OF
Varnum LLP

Employers’ Immigration Law Update – September 2014

Jackson Lewis Law firm

ICE Levies $2M Fine against Hotel for I-9 Related Violations

A Salt Lake City-based hotel will have to pay nearly $2 million for hiring unauthorized workers, including illegal aliens. The hotel will avoid criminal prosecution in exchange for its full cooperation with a U.S. Immigration and Customs Enforcement investigation and for taking action to correct its hiring practices. According to the non-prosecution agreement, several lower-level employees and mid-level managers conspired to rehire unauthorized workers amidst an administrative audit of I-9 employee verification forms that began in September 2010. The hotel was notified that 133 employees were not authorized to work in the United States; however, the conspirators created three temporary employment agencies, essentially shell companies, to rehire 43 of the unauthorized, and most of the workers returned under different names using fraudulent identity documents.

$300K for H-2B Violations

According to a Department of Labor announcement, the agency has charged a landscaping company with violating federal law by failing to hire U.S. workers, and for underpaying temporary foreign workers. The company will pay $280,000 in back wages to 80 workers and nine job applicants and $20,000 in civil money penalties.

Immigration Reform Update

With comprehensive immigration reform legislation no longer a realistic possibility for the foreseeable future, advocates for reform have shifted their focus to executive actions the President may take unilaterally to implement changes in immigration policy.

The President reportedly is considering broad use of executive action, granting relief potentially to up to 6 million undocumented individuals, similar to what has been provided under the administration’s Deferred Action to Childhood Arrivals program (DACA).

Building off of DACA, the President has directed the Department of Homeland Security to review the administration’s immigration enforcement policies and recommend additional changes, possibly expanding the deferred action and work authorization to family members of U.S. citizens and lawful U.S. residents. The administration reportedly also is looking at possible changes to current law and regulation that could benefit employers.

Any unilateral action by the administration likely will be controversial.

Owner Liable for H-1B, J-1 Costs

The owner of several medical clinics is personally liable for back wages and the costs of physicians’ H-1B visas and J-1 waivers, the Court of Appeals for the Sixth Circuit has ruled. Kutty v. DOL, No. 11-6120 (6th Cir. Aug. 20, 2014). The Court held Dr. Mohan Kutty and his medical clinics violated H-1B provisions by having physicians cover the costs of their own H-1B visa petitions and related J-1 visa waivers.

Department of Defense Contractors Agree to Pay the U.S. Government $5.5 Million for Allegedly Supplying the Military with Low-Grade Batteries for Humvee Gun Turrets Used in Iraq; Minnesota Whistleblower to Receive $990,000

tz logo 2

On September 16, 2014, the Department of Justice (DOJ) announced that Department of Defense (DOD) contractors, M.K. Battery, Inc. (M.K. Battery), East Penn Manufacturing Company (East Penn), NPC Robotics, Inc. (NPC), BAE Systems, Inc. (BAE) and BAE Systems Tactical Vehicle Systems LP (BAE) had agreed to a settlement of $5.5 million for allegedly violating the False Claims Act (FCA) by selling the U.S. Military substandard batteries for Humvee gun turrets used on military combat vehicles in Iraq. Minnesota whistleblower, David McIntosh, former employee of M.K. Battery, will receive $990,000 which represents his share of the settlement for reporting fraud against the government – in this case misrepresentation of a vital product supplied to the DOD.

A gun turret is a weapon mount that protects the crew or mechanism of a projectile-firing weapon and at the same time lets the weapon be aimed and fired in many directions. Sealed acid batteries are used as a backup to turn the turrets on the Humvees in the event that the engine gives out.  According to Mr. McIntosh, and unbeknownst to the Army, the manufacturing process of the batteries was allegedly changed from the original design presented to the DOD, consequently cutting the battery’s life span by as much as 50 percent and potentially putting U.S. Troops in harm’s way.  Mr. McIntosh, from Stacy, Minnesota, who at the time was employed by M.K. Battery as a regional sales representative, brought his concerns to top company officials at M.K. Battery.  However, in 2007 after numerous unsuccessful attempts to convince M.K. Battery that its decision to cut costs on these batteries could be hazardous to U.S. Troops, especially during combat, Mr. McIntosh alerted the DOD to this matter.  Three month later, M.K. Battery fired Mr. McIntosh.

Shortly thereafter, Mr. McIntosh and his attorneys filed the lawsuit under the whistleblowersprovisions of the False Claims Act, which is one of the most effective methods that the government has implemented for combating fraud. Under the FCA, any person, who knows of an individual or company that has defrauded the federal government, can file a “qui tam” lawsuit to recover damages on the government’s behalf.  Mr. McIntosh filed this particular lawsuit on behalf of himself and the Department of Defense. Additionally, a whistleblower who files a case against a company that has committed fraud against the government, may receive an award of up to 30 percent of the settlement. In this case, Mr. McIntosh’s share of $5.5 million is approximately 18 percent of the settlement.

ARTICLE BY

Whistleblower Practice Group
OF
Tycko & Zavareei LLP
© 2014 by Tycko & Zavareei LLP

Effective September 12, 2014: New Fees for Some Nonimmigrant and Immigrant Visas

Mintz Levin Law Firm

The Department of State (DOS) has revised certain nonimmigrant and immigrant visa fees. DOS has adjusted the visa fees in the following categories:

  1. E visas – treaty/trader and Australian specialty occupation visas decreased to $205 (from $270).

  2. K visas – Fiancé(e) or Spouse of U.S. citizen category visa increased to $265.

  3. Immigrant visa application processing fee based on an approved I-130 Immediate Relative of Family Preference petition increased to $325.

  4. Immigrant visa processing fee based on an approved I-140 employment-based petition decreased to $345 (from $405).

As detailed on the DOS website, the following procedures apply:

  1. DOS will not refund the difference for fees that have been lowered.

  2. If you are applying for a category where the fee has been raised and you have already paid the fee, you are not required to pay the difference between the amount you paid and the new fee as long as your appointment is on or before December 11, 2014.

  3. If you are applying for a category where the fee has been raised, you are required to pay the difference between the amount you paid and the new fee if your appointment is on or after December 12, 2014.

ARTICLE BY

Barbara Chin
OF
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

CBP Announces Optimized Processing for First-Time Canadian TN and L Applicants

Greenberg Traurig Law firm

U.S. Customs and Border Protection (CBP) has announced optimized processing procedures at fourteen ports-of-entry, including four pre-clearance locations, for Canadian citizens seeking TN or L status for the first time. This initiative is designed to increase customer satisfaction, decrease wait times and allow CBP to effectively deal with increased volume of Canadian TN and L applicants. Although first-time Canadian TN and L applicants may go to other ports for processing, CBP is encouraging applicants to go through one of the designated ports below for optimized processing:

Pre-Flight Inspection Locations

  • Pearson International Airport, Toronto, Ontario

  • Trudeau International Airport, Dorval, Quebec

  • Vancouver International Airport, Richmond, British Columbia

  • Calgary International Airport, Calgary, Alberta

Land Port Locations

  • Highgate Springs Port of Entry, Highgate Springs, Vermont

  • Derby Line Port of Entry, Derby Line, Vermont

  • Alexandria Bay Port of Entry, Alexandria, New York

  • Peace Bridge Port of Entry, Buffalo, New York

  • Rainbow Bridge Port of Entry, Niagara Falls, New York

  • Champlain Port of Entry, Champlain, New York

  • Detroit Canada Tunnel Port of Entry, Detroit, Michigan

  • Detroit Ambassador Bridge Port of Entry, Detroit, Michigan

  • Blaine Peace Arch Port of Entry, Blaine, Washington

  • Sweetgrass Port of Entry,  Sweetgrass Montana

ARTICLE BY

Ian R. Macdonald
OF
Greenberg Traurig, LLP

President Obama’s Response to the Ebola Crisis

According to the U.S. Department of Defense, December 30, 2013 was epidemiological week 1 for the current Ebola crisis in West Africa.  Since that date, more than 4,985 cases — 2,461 of which have resulted in death — have been confirmed or suspected.

Today, nine months after the epidemic’s outbreak, President Obama has made an overdue announcement that the U.S. will deploy an estimated 3,000 troops in an effort to stem the crisis.  The response is certainly welcome but it remains far from certain that an intervention by the U.S. military will be sufficient to defeat this deadly epidemic.

President Obama is right to characterize the Ebola outbreak as a top national security priority for the U.S., and the past is instructive for what we might be dealing with in this situation.

The last time that the U.S. declared a health emergency to be a threat to U.S. national security was in 2000, when the Clinton administration designated HIV/AIDS as a threat that could undermine governments, lead to conflict and weaken progress on democracy and economic growth.  At that time, the Clinton Administration doubled its budget request to combat HIV/AIDS internationally to $254 million.  However, it was not until 2003 when President George W. Bush requested from Congress $15 billion over five years that the U.S. began to turn the tide of that deadly pandemic.  It was still another two years before medicines became widely available to those infected with HIV and, in 2008, PEPFAR was reauthorized for $48 billion for another five years.

To date, the Obama administration has spent $175 million to address the rapidly spreading Ebola crisis in West Africa.  This is likely to be a fraction of the ultimate cost required to defeat this disease.  Recent estimates from the United Nations place the costs around $1 billion.

In addition to involving the U.S. military, President Obama has committed the U.S. to the construction of 17 treatment centers (each of which will have 100  beds) in Liberia and the establishment of a site to train up to 500 local health care providers per week.  In terms of containing this deadly disease, this “whole of government” response from the Obama Administration is a good, if belated, start.  However, key questions remain.

It is not clear how long the strategy will take to implement and, according to international health officials who spoke with The New York Times, 1,000 beds are needed in the next week alone to contain the spread of the disease.  It also is not clear how the U.S. will work with the governments of Sierra Leone and Guinea, as nearly half the cases reported come from those two countries, nor Nigeria and Senegal who also have reported cases.

Over the weekend, chief executives from 11 companies operating in Liberia, Sierra Leone and Guinea made an urgent appeal to the international community to pool its resources to fight Ebola.  It is an important development that the U.S. is moving forward with a more aggressive response to this plea.  Yet victory will likely require a “whole of community” response from all stakeholders, including governments, businesses, NGOs and others, who want to see the governments of West Africa defeat this deadly scourge.

ARTICLE BY

Witney Schneidman
OF
Covington & Burling LLP