New Indictments, Arrests in Multi-State Health Care Fraud Scheme

/0 Comments/in , , /by

On June 24, 2009, Federal agents descended on Miami, Detroit and Denver, as well as other major cities, in a new round of arrests targeting Medicare fraud in those cities. Fifty-three Federal indictments were handed down early in the day by a grand jury in Detroit, and a wave of arrests soon followed. All tolled, the newly indicted suspects are charged with conspiring to defraud Medicare of over $56 million.

The indictments involve fake prescriptions, cash bribes, and stolen Medicare information, including physician identification numbers. As reported in our earlier blog posting, Federal and state government authorities under the Health Care Fraud Prevention & Enforcement Action Team (HEAT) taskforce have recognized the severity of healthcare fraud in South Florida and have been cracking down on these fraudulent schemes. Heightened enforcement in South Florida forced the group to extend their scheme to Detroit, which has become the latest site for Medicare fraud, and other cities to take advantage of Medicare funds.

According to the indictments, the defendants – including doctors, clinic owners, assistants, and patients – submitted millions of dollars in false claims to Medicare for infusion therapy, injection therapy, and other high-priced medical treatments that are designed to treat patients suffering from illnesses such as HIV, AIDS, and cancer.

“As demonstrated by today’s charges and arrests, we will strike back against those whose fraudulent schemes not only undermine a program upon which 45 million aged and disabled Americans depend, but which also contribute directly to rising healthcare costs that all Americans must bear,” U.S. Attorney General Eric Holder said at the press conference announcing the indictments and arrests.

The suspects identified in the Detroit indictments have clear connections to Miami, Florida. In 2008, it is estimated that that city’s prosecutions account for more than one-third of all Medicare fraud cases nationwide. “In fact, ten of the defendants named in the indictments unsealed today are alleged to have brought their fraud schemes from Miami to Detroit,” reported Holder. “Strike force operations in Miami have seen instances of fraud spread quickly through communities in that area. After we arrested and charged criminals in Miami, their cohorts simply moved their schemes to Detroit.”

All together, strikes forces in Miami, Los Angeles and Detroit have charged 249 defendants for Medicare fraud involving about $600 million in false claims for mostly HIV infusion services and medical equipment.

For the U.S. Attorney General’s press release on the indictments and arrests, click here.

For more information about how Fuerst Ittleman can assist your Medicare and health care regulatory compliance and protect against fraud, please contact us at 305-350-5690 or contact@fidjlaw.com.

Court Authorizes Refund of EU Retaliatory Duties

/0 Comments/in , , , /by

On June 16, 2009, Gilda Industries, a small bakery and importer in Hialeah, Florida, struck a blow for importers everywhere when it prevailed in its case in the U.S. Court of International Trade.  The result of this case is that importers everywhere may qualify for a full refund of the 100% retaliatory duties paid to U.S. Customs and Border Protection (CBP) on certain products imported from the European Union on or after July 29, 2007.

The decision in Gilda Industries v. United States becomes the latest chapter in what is known as the “EC-Beef Hormones” dispute.  The dispute began in 1985 when the European Community (now the European Union) banned imports of beef and beef products from the United States that had been treated with hormones.  As a result, the U.S. imposed a 100% retaliatory tariff on a “retaliation list” of European Union products.

In theory, the retaliatory measures should have ended in mid-2007.  However, when CBP continued to collect the retaliatory tariffs after that date, Gilda took the matter to court.

The Court found that the 100% retaliatory tariffs did, in fact, terminate on July 29, 2007, and it ordered CBP to refund the retaliatory duties collected on Gilda’s imports after that date.  The Court’s opinion, however, opens the door for a full refund on all of the retaliatory duties paid to CBP after that date for all of the affected products

Importers who qualify for refunds should immediately file an action with the U.S. Court of International Trade to preserve the right to the refunds.  These actions must be filed before July 29, 2009.

The list of products subject to the 100% retaliatory duties – for which refund may be due -includes various meats, cheeses, vegetables and other food items.  For the complete list of products affected, click here.

For the decision of the Court in Gilda Industries v. United States, click here.

If you are importer who believes that you may be due refunds of duties from CBP under this decision, please contact Fuerst Ittleman at 305-350-5690 or contact@fidjlaw.com.  You should not delay.

Healthcare Fraud Crackdown Expanded in Miami-Dade County

/0 Comments/in , , , /by

Efforts to crack down on Medicare and Medicaid fraud has focused the radars of federal and state law enforcement onto the Miami-Dade county area. On June 19, 2009, state investigators from the Florida Agency for Health Care Administration (“AHCA”) revealed more Medicaid fraud in Miami-Dade: the state paid for unnecessary or unaccounted oxygen equipment.

Recent government studies have estimated Medicare and Medicaid fraud to be at least $60 billion a year nationwide. According to the FBI and the Department of Justice, Medicare and Medicaid fraud is big business in Miami Dade County reaching at least $2.5 billion a year.

Fraudulent billing for medical equipment is the latest scam plaguing Medicaid which, according to the AHCA, spent over $90 million on medical equipment last year alone. When over $1.4 million was spent on oxygen equipment in Miami-Dade County last year, this raised the suspicions of the AHCA.

Attempts to curb Medicaid and Medicare fraud in South Florida are nothing new. In March, Medicaid investigators commenced similar investigations of Miami-Dade’s home health industry. On June 15th, Governor Charlie Christ signed into law a bill that declared Miami-Dade a “crisis area for healthcare fraud” and tightened regulations on home health agencies, home medical equipment providers, and health care clinics.

These recent efforts by the state come on top of increased efforts by the federal government to stem the tide of fraud and wasteful government spending in Medicare and Medicaid. The first of these efforts, the Medicare Strike Force, was started in 2007. In two years, federal prosecutors have filed 87 indictments charging 159 defendants with fraud offenses. This past May, the federal government announced a new task force – the Health Care Fraud Prevention and Enforcement Team, or HEAT – which will increase healthcare fraud enforcement in Miami-Dade County.

With increased efforts of law enforcement cracking down on the industry, let FHI help your health care business with its regulatory compliance. Contact us at 305-350-5690 or contact@fidjlaw.com.

Fuerst Ittleman Assists Clients and Earns a “Thank You”

/0 Comments/in , , , , , , , , , , /by

Bio-Nucleonics, Inc., a leading Florida company specializing in radiopharmaceuticals, medical devices and imaging agents, gave a hearty “Thanks” to Fuerst Ittleman in its most recent issue of BioBulletin, the companys newsletter.

Fuerst Ittleman recently assisted Bio-Nucleonics with gaining FDA approval for the companys new Doral, Florida product manufacturing facility. The FDAs approval certifies that Bio-Nucleonics uses “current Good Manufacturing Practice” (cGMP) in all its production at this state-of-the art facility.

The FDA also gave approval to Bio-Nucleonics for its proposed release criteria and timeframes for specific lot release tests to be completed prior to shipment of finished drug products. The importance of this ruling is that no material is lost to radioactive decay and each dose can be shipped immediately to the customer.

FHI assisted Bio-Nucleonics with both of these efforts. We found it such a pleasure to work with clients who were as knowledgeable, dedicated, and thorough as the team at Bio-Nucleonics, and were glad that they liked working with us, too.

Let Fuerst Ittleman help guide your company to its next success. For more information, contact us today at 305.350.5690 or contact@fidjlaw.com

Food Safety Legislation Update

/0 Comments/in , , , , , /by

The House Energy and Commerce Committee convened to discuss draft legislation that would broadly affect regulation of food production, importation, and manufacturing inside and outside of the U.S.  Newly confirmed FDA Commissioner Margaret Hamburg testified before the committee on The Food Safety Enhancement Act of 2009 (FSEA).

 

FSEAs major initiatives are:

  • Registration fees for domestic and foreign producers as well as importers
  • Creation of an identification system for businesses in the food supply chain
  • Risk-based frequency levels of inspection
  • Increasing FDAs subpoena power
  • Two tier approach to recalls: voluntary and mandatory

Democratic Party proponents, led by Representative Dingell of Michigan, emphasized the “dire situation” of food safety and characterized the legislation as a means of recreating the FDA with new and stronger enforcement and financing tools.  Opponents largely criticized the passing of costs to consumers, regulation that does not guarantee results, and also chided the hearing on draft legislation, rather than a finalized text.  Another recurring critique was the broad discretion given to make mandatory recalls.  Some committee members took exception to the Commissioners admission that senior officials, not only the Commissioner, might be given the power to issue mandatory recalls.

 

Commissioner Hamburg unequivocally supported the legislation, saying that it would base food safety monitoring on prevention.  She also agreed with the legislations legal empowerment of the agency as well as its requirement that user fees be generated by the food industry.

Scientific Developments in Induced Pluripotent Stem Cells

/0 Comments/in , , , , /by

This week has seen the publication of two reports of groundbreaking results in the field of stem cell research.

 

Scientists at San Diego Californias Salk Institute for Biological Studies have published a report in Nature describing the creation of induced pluripotent stem (iPS) cells.  Dr. Juan Carlos Izpisua Belmontes team applied gene therapy techniques to correct defective cells from patients afflicted with Fanconi anemia.  The team reports that the created iPS cells are indistinguishable from human embryonic stem cells.  Although the research has not yet been used in humans, the iPS cells create hope that such correction might be done to the diseased cells of Fanconi anemia patients. Upon correction, the cells could be reintroduced to the patient, without risk of rejection, to rid the patient of the affliction.

 

Chinese Scientists at the Shanghai Institute of Biochemistry and Cell Biology have created iPS cells adaptable to the human body from the tissue of pigs.  Similarly, the iPS cells resulting from the Chinese teams procedure are identical to embryonic stem cells.  Researchers believe that these results accomplish a necessary step towards the use of pigs to generate human-compatible organs.  Some also think this research could enable human-like simulations of human diseases and thus a platform for drug and biologic testing which would be as much like a human clinical trial as possible.

 

View the reports here:
http://www.nature.com/nature/journal/vaop/ncurrent/pdf/nature08129.pdf

http://jmcb.oxfordjournals.org/cgi/content/abstract/mjp003

 

Foreign Bank Accounts and the IRS

/in , , , , , , , , , /by

Original Article: Mitchell S. Fuerst: Foreign Bank Accounts and the IRS [pdf]

Orthopedic Implant Companies Out of Fed Oversight

/in , , , , /by

Four primary orthopedic implant companies that have been accused of violations to the federal anti-kickback laws are no longer the subject of the U.S. Attorneys offices federal oversight and have also been dismissed from criminal allegations that surgeons had received enormous sums of money as incentives to use their devices.

To avoid prosecution, the companies had agreed to accepting rigorous regulatory compliance procedures and a monitoring program by the federal government. Those agreements drew a great deal of criticism to U.S. Attorney Christopher Christie, when it was revealed that the former Attorney General, John Ashcroft, was appointed by Christie to a monitoring program contract estimated to be worth up to $52 million. Christie, the Republican gubernatorial nominee hopeful, faced some tough questions about his relationship to, and the appointment of federal monitoring program supervisor – former federal Judge Herbert J. Stern. Judge Stern and his law firm were responsible for contributions of more than $20,000 to Christies campaign fund.

When asked about the current relationship in light of the circumstances, Christie simply dismissed the matter as, “typical political stuff …”

After federal prosecutors discovered incidents where orthopedic surgeons had received consultation fees upwards of $200,000 a year for the promotion of products from orthopedic implant companies, the U.S. Attorneys office pursued formal criminal charges alleging the actions were a violation of federal anti-kickback laws that govern Medicare provisioned hospitals and healthcare professionals.

According to the federal prosecutors, the medical device companies were using the consulting agreements as a cover-up for payoffs to use specific implant products for artificial hip or knee replacement operations. Furthermore, the U.S. Attorneys office claim that these payments and fees are commonplace in the industry and may also be accompanied by luxurious gifts, and extravagant trips.

The investigators found evidence that the physicians had actually performed very little to no consulting work whatsoever and had received funds from the orthopedic companies solely for the use of their products, and failed to keep accurate reports disclosing their relationship with the medical device companies to the patients that received the surgery or the hospitals where the surgeries were performed.

Biomet Orthopedics Inc., Zimmer Inc., Smith & Nephew Inc., and DePuy Orthopeadics Inc., agreed to paying $311 million in a civil settlement agreement and accepted a deferred prosecution agreement which would expire should the companies agree to an extended monitoring program and implement stringent reforms.

The appointee to the monitoring of Zimmer Inc., was John Ashcroft. Zimmer Inc., was not willing to disclose the amount that was paid to Ashcrofts law firm. However, according to the firms spokesperson, the payments were around $6 to $9 million dollars a quarter.

Federal Agencies Publish “Good Importer Practices”

/0 Comments/in , , , , /by

On January 12, 2009, the Interagency Working Group on Import Safety published draft guidance for industry entitled “Good Importer Practices.” The working group is comprised of the U. S. Departments of Health and Human Services (Food and Drug Administration), Agriculture, Commerce, Homeland Security, and Transportation and the U.S. Consumer Product Safety Commission, the U.S. Environmental Protection Agency, and the Office of the U.S. Trade Representative.

The Working Group organized the guidance into four broad “guiding principles”:

– establishing a product safety management program;
– knowing the product and applicable U.S. requirements;
– verifying product and firm compliance (throughout supply chain and life cycle); and
– taking corrective and preventive action (when necessary).

These principles give importers a roadmap they can follow to ensure that the products they import, and the processes they use to import those products, comply with myriad U.S. statutes and regulations. While the document is not a “how to” guide “ with steps that match up to specific code citations “ the guidance is an indispensible tool for management, which they can use to make sure that they are asking the right questions, and establishing the right programs and processes, for regulatory compliance.

The draft guidance encourages importers to focus on the life cycle of an imported product; for example, from growing and harvesting, to processing, packing, transporting, and distributing. At each step, importers should consider how to implement controls to help decrease the risk that the product could cause harm to people, animals, or the environment. In doing so, importers will help ensure overall regulatory compliance.

The guidance is also important for third-parties in the import process, such as consolidators, shippers, brokers and distributors. In the current regulatory environment, in which the government is focusing on everyones role in the security and safety of imports (and penalizing those who break the rules), even these third-parties should have processes in place to make sure that the importers with whom they work are complying with government rules and regulations.

Following this guidance laid out by the government is essential for all U.S. importers. If you dont follow the roadmap, you may soon be lost.

The complete “Draft Guidance for Industry Good Importer Practices” can be found here.

Let Fuerst Ittleman help you with your roadmap for regulatory compliance. Our attorneys have years of experience in designing programs, policies and procedures to help importers stay on the right path and avoid problems with regulators. Contact us at 305-350-5690 or contact@fidjlaw.com.

A Rosa gallica by any other name?USDA Levies New Requirements on Imported Plants and Plant Products

/0 Comments/in , , /by

The Lacey Act is the U.S. Department of Agriculture’s primary tool for combating illegal imports of wildlife, fish, and plants. Under the Act, it is unlawful to import – or for that matter to “export, transport, sell, receive, acquire, or purchase” – any plant harvested or traded in violation of any state’s laws, or most foreign laws.

Amendments to the Act in 2008 expanded its reach to protect more plants and plant products. (Before these amendments, many of these restrictions only applied to endangered species.) As of December 15, 2008, certain plants and plant products cannot be imported into the United States without an import declaration. This declaration must indentify the following information:

– scientific name of any imported plant (including genus and species),
– value of the importation,
– quantity of the plant, and
– name of the country from which the plant was taken (not just exported).

There are certain types of plants that are exempt from the new amendments. These include “common cultivars” (except trees), common food crops, scientific specimens of plant genetic material used in research, and plants that are to remain planted or to be planted or replanted. The USDA will be defining exactly what is meant by a “common cultivar” in the coming months.

It is important to note that import declarations are also required for plant products. Examples of such products – to the extent that they contain covered plants – include lumber, paper, furniture, sporting goods, musical instruments, vehicles, pharmaceuticals and textiles. The effect for importers will be far-reaching.

An electronic system soon will become available for collecting the information required on the declaration. In the meantime, importers may submit a paper form containing the required information on a voluntary basis. Once the electronic systems are in place, declarations will be mandatory and civil and criminal penalties may apply for failure to comply. Merchandise found to be in violation of these provisions may be subject to seizure and forfeiture.

To help importers generate the required information, USDA’s Animal and Plant Health Inspection Service (APHIS) has developed an online tool for looking up the genus and species names of plants. The tool is invaluable for complying with the new Lacey Act amendments. It can also make you sound smarter as you present your loved one with a gorgeous bouquet of Dianthus caryophyllus.

Fuerst Ittleman has years of experience in meeting USDA and other government agency requirements for the importation of plants and plant products. For assistance with your valuable importations, please contact us at 305 350 5690 or contact@fidjlaw.com.