How Can FDA More Reasonably Regulate Autologous Stem Cell Procedures?

In the December 26, 2012 edition of the Food & Drug Law Institutes (FDLI) Policy Forum, Andrew Ittleman of Fuerst Ittleman David & Joseph took on the question of how FDA may more reasonably regulate autologous stem cell procedures. In the article, Mr. Ittleman concludes that FDA, under certain circumstances described in the article, should exercise “enforcement discretion” with respect to autologous stem cell procedures. Mr. Ittleman also describes how FDA has interpreted the concepts of “minimal manipulation,” and “homologous use,” and discusses FDAs regulation of autologous stem cell procedures as being in direct conflict with traditional notions of the practice of medicine. A copy of the article is available here.

Is it drug manufacturing or the practice of medicine? Stem cell therapy debate just getting started

By: Stephanie Baum
August 3, 2012

The latest round of a stem cell debate may have concluded, but as far as the lawyers representing an orthopedics company that has offered stem cell treatments are concerned, it’s a long way from over.

The lawyers representing Colorado-based Regenerative Science said they were filing a notice of appeal this week after a U.S. District Court judge’s ruling in favor of the U.S. Food and Drug Administration that its stem cell therapy is a drug. The case is being closely watched by everyone with a stake or an interest in the use of stem cells in medicine and could have significant ramifications for stem cell entrepreneurs who don’t believe their procedures amount to a drug or biologic.

Regenerative Science

Andrew Ittleman of Fuerst Ittleman is part of the legal team representing Regenerative Science. Although he acknowledged that the company has had to suspend its cell culture process, he said the ruling doesn’t really change anything in the big picture of stem cell policy. “If anything, [the decision] preserves the status quo, but the problem with that is that there’s so much uncertainty regarding what doctors can do and can’t do.”

Colorado-based Regnerative Science’s Regenexx procedure is presented as an alternative to traditional surgery that can treat fractures that have failed to heal, joint cartilage problems, partial tears of tendons, muscles, or ligaments, among other problems. It works like this: A physician takes a small bone marrow sample from the back of the patient’s hip through a needle. Blood samples are taken from a vein in the patient’s arm. The samples are sent to the Regenerative laboratory where the mesenchymal stem cells are isolated from the bone marrow and grown to greater numbers using growth factors in the patient’s blood. The stem cells are injected back into the relevant area in the patient.

The FDA initially sent a warning letter to Regenerative in 2008 after seeing its website. The company turned around and sued the FDA, and two years ago the FDA sought an injunction to shut it down.

The companies that occupy the stem cell treatment landscape are as diverse a group as you could hope to find in medicine. Some offer age-defying beauty solutions, others provide life-saving technology, others have quality-of-life-improving treatments for joints and muscles. There are entrepreneurs leading startups and Big Pharma companies too.

In 2010, the stem cell therapy market was $139.6 million and it was projected to grow to $1 billion by 2015, according to data compiled by Robin Young, the publisher of Orthopedics Week and the CEO of medical data mining company PearlDiver Technologies.

“This is on the very cutting edge of medicine and the FDA needs to move forward with it by making sure they have the best information on this science available to inform their decision-making,” said Michelle Hart Yeary, counsel with Dechert’s life science practice.

Minimally manipulated

The source for the debate comes from the regulatory framework the FDA set up in 2001 in light of the development of research and medical treatments using human cells, tissues and cellular or tissue-based products (human cell or tissue products) “to improve protection of the public health without imposing unnecessary restrictions on research, development or the availability of new products,” according to court documents. One point in this framework is that human cells or tissue can only be minimally manipulated. Minimal manipulation is defined as “processing that does not alter the relevant biological characteristics of cells or tissues.”

“There are lots of doctors out there using stem cell treatments,” said Arnie Friede of Arnie I Friede & Associates, a New York-based food and drug lawyer who has served as an associate chief counsel in the FDA chief counsel’s office. “I think you have to distinguish between people in traditional drug development and others engaged in different procedures that amount to the practice of medicine.”

Yeary says the regulator should evaluate cases on an individual basis. “Given the ‘minimally manipulate’ standard hasn’t been fully defined by the FDA or fully interpreted by the courts, I think decisions will need to be made on a case-by-case basis. This follows from the evolving state of the law.”

The case for stem cell treatments as drug manufacturing

Drug manufacturers that have invested millions in ensuring their facilities meet good manufacturing practices meeting FDA requirements and carrying out clinical trials to prove the efficacy and safety of their products have welcomed the ruling.

Christopher Scott, the director of Stanford University’s stem cell program for its center for biomedical ethics, told New Scientist he hoped it would lead to more FDA investigations of unproven stem cell treatments at other clinics.

Fibrocell is developing a platform technology to produce mesenchymal stem cells that are being used in research to develop osteoblasts, or bone cells; chondrocytes, or cartilage cells; and adipocytes, or fat cells. David Pernock also said he welcomed the judge’s decision.

Juventas Therapeutics recently raised $22 million for two phase 2 trials for chronic heart failure and for critical limb ischemia testing its stem cell treatment, JVS-100, which uses a protein naturally produced by the heart (stromal cell-derived factor 1) that attracts stem cells to damaged tissue, keeps cells from dying and restores blood flow. Medical device company Histogenics Corp. is raising $49 million in part to get CE Mark approval for its VeriCart  product — a single-step, cell-free collagen scaffold  designed to be used with the patient’s own stem cells to repair small cartilage defects associated with knee injuries.

If Regenerative Science ultimately loses, it could lead to a significant decrease in the number of stem cell companies unprepared to fork out more for the years of development needed to bring a drug or biologic to the FDA approval finish line. Perhaps having members of the stem cell industry work with the FDA to hammer out some more coherent regulations could better fill the perceived gaps between the medical industry and drug and medical device companies.

To view original article, click here.

Eleventh Circuit Court of Appeals Creates Deeper Circuit Split Over Pre-Trial Restraint of Assets

The 11th Circuit Court of Appeals, based in Atlanta, issued its opinion on April 26, 2012, in the case of United States of America v. Kaley, ___ F.3d___, available here; (“Kaley II”).  The Defendants challenged a district courts order denying their motion to vacate a pretrial protective order restraining their assets. This is the second time the case came before the 11th Circuit.  In United States v. Kaley, 579 F.3d 1246 (11th Cir. 2009) (“Kaley I“), available

here, the 11th Circuit reversed the district courts order which had concluded that the Kaleys were not entitled to a pretrial evidentiary hearing on their motion to vacate the protective order, and remanded the matter for further proceedings. On remand, the district court determined that the Kaleys were entitled to a pretrial, post-restraint hearing, but that the only question to be addressed at the hearing was whether the restrained assets were traceable to or involved in the conduct charged in the indictment. At the hearing, the Kaleys did not present any evidence regarding traceability, and the district court declined to set aside the protective order.

The relevant facts are as follows:

In January 2005, Kerri Kaley, then a sales representative with Ethicon Endo-Surgery, was informed she was the target of a grand jury investigation in the Southern District of Florida. Kaley was suspected of stealing prescription medical devices (“PMDs”) from hospitals and then selling them on the black market. Kaley retained counsel in the investigation. Kaleys husband, Brian Kaley, who was also under investigation, retained a separate attorney. Together, the two attorneys informed the Kaleys that their legal fees to take the case through trial would be approximately $500,000. To obtain funds to pay those fees, the Kaleys applied for and obtained a home equity line of credit of $500,000 on their residence and used the proceeds to buy a certificate of deposit (“CD”).

On February 6, 2007, the grand jury returned a seven-count indictment against the Kaleys.  Count One charged a conspiracy to transport PMDs in interstate commerce while knowing them to have been stolen, in violation of 18 U.S.C. § 371, available here. Counts Two through Six charged five substantive 18 U.S.C. § 2314 offenses, available here and Count Seven charged obstruction of justice, in violation of 18 U.S.C. § 1512(b)(3), available here. The indictment also sought criminal forfeiture of all property traceable to the § 2314 offenses, including the CD.

On February 7, 2007, the Government moved the district court ex parte for a protective order restraining the Kaleys from transferring or otherwise disposing of the property listed in the forfeiture count, and a magistrate judge, concluding that the indictment established probable cause that the property was “traceable to” the Kaleys commission of the § 2314 offenses, granted the motion the same day.

On March 5, 2007, the Kaleys moved the district court to vacate the February 7th protective order. They contended that the order prevented them from retaining counsel of their choice in violation of their Sixth Amendment right to the representation of counsel. A magistrate judge heard this motion too on April 6th and sustained the protective order; however, he limited the protective orders scope (insofar as it applied to the CD) to $140,000.

On April 10, 2007, the grand jury returned a superseding indictment. This indictment replicated the first seven counts of the first indictment and added an additional count — a charge that the Kaleys had conspired to launder the proceeds of the § 2314 offenses, in violation of 18 U.S.C. § 1956(h), available here. This indictment also sought the criminal forfeiture of the CD and the Kaleys residence on the theory that those assets were “involved in” the Kaleys commission of the § 1956(h) offense. On April 17th, the Kaleys renewed their motion to vacate the February 7th protective order (as amended by the order of April 6th), and expressly requested a pretrial, post-restraint evidentiary hearing.  The magistrate judge heard the motion on April 27th. He questioned whether the indictment alone provided probable cause to restrain the defendants assets and ordered the prosecutor to submit an affidavit supporting probable cause. The prosecutor responded by filing, in secret and under seal, an affidavit executed by the FBI case agent.

On May 1, 2007, the magistrate judge issued two orders. In the first order, he found probable cause — based on the indictment and the case agents affidavit — that the CD and the Kaleys residence were “involved in” the violations of § 1956(h) and § 2314. In the second order, he amended the February 7th protective order to include within its scope the full value of the CD and the Kaleys residence. On May 2nd, the magistrate judge issued a third order denying the Kaleys motion to vacate the protective order and to hold a pretrial, post-restraint evidentiary hearing.

The 11th Circuit in Kaley I, held under United States v. Bissell, 866 F.2d 1343 (11th Cir. 1989), available here, that a defendant whose assets are restrained pursuant to a criminal forfeiture charge in an indictment, rendering him unable to afford counsel of choice, is entitled to a pretrial hearing only if the balancing test enunciated in Barker v. Wingo, 407 U.S. 514 (1972), available here, is satisfied. Id. at 1353. The 11th Circuit in Kaley I concluded that the district court incorrectly applied that test, and reversed and remand the case for further consideration consistent with the opinion in Kaley I.

However, Judge Tjoflat wrote a specially concurring opinion that asserted that the 11th Circuits decision in Bissell, was dicta, and hence not binding on the Kaley I court.  Judge Tjoflat stated:  “In the absence of binding precedent, the panel should have looked to the general requirements of procedural due process.” See United States v. E-Gold Ltd., 521 F.3d 411, 415 (D.C. Cir. 2008) (using this approach to determine whether a post-restraint, pretrial hearing was due), available here. (Andrew Ittleman of Fuerst Ittleman, PL was counsel of record in the E-Gold case before the D.C. Circuit Court.)

After remand, an evidentiary hearing was conducted on July 29, 2010, and the district court heard arguments from the parties regarding the hearings proper scope. The Kaleys explained that they were not contesting whether the restrained assets were traceable to or involved in the conduct charged in the indictment, but instead were taking the position that the protective order should be vacated because the underlying facts did not support the crimes charged in the first place. The government responded that, in light of this Courts decisions in Bissell and Kaley I, it was not required to offer substantive evidence from its case against the Kaleys in order to establish the evidentiary foundation of the criminal charges, and that the only purpose of the hearing was to determine whether the restrained assets were traceable to or involved in the conduct charged in the indictment. 

On October 24, 2010, the district court issued an order denying the Kaleys motion to vacate the protective order. Citing language taken from Bissell and Kaley I, the district court concluded that the only relevant inquiry at the hearing was whether the restrained assets were traceable to or involved in the alleged criminal conduct. Because the Kaleys did not attempt to challenge traceability in any way — arguing only that the governments underlying case had no merit “ the district court denied their motion to vacate the protective order. On October 27, 2010, the Kaleys filed their second appeal from the district courts order.

On appeal in Kaley II, the 11th Circuit examined the scope and purpose of the forfeiture statute, 21 U.S.C. section 853, available here. The 11th Circuit noted that Section 853 does not require a hearing for the issuance or continuation of a post-indictment restraining order. Under subparagraph (1)(B), to obtain such a restraining order before the filing of an indictment requires “notice to persons appearing to have an interest in the property and opportunity for a hearing.” Id. § 853(e)(1)(B). But, in sharp contrast, subparagraph (1)(A), dealing with post-indictment restraining orders, contains no such requirement. See id. § 853(e)(1)(A).  Since the statute itself imposes no hearing requirement, the only pretrial hearing required is one provided under the Due Process Clause.

The question before the 11th Circuit in Kaley II was what exactly what  the hearing requires. Kaley I suggested that the defendants cannot challenge the underlying indictment itself, and the 11th Circuit expressly so held. The basis for the decision was a line of U.S. Supreme Court cases that held that the grand jurys function cannot be usurped by the Courts; see Costello v. United States, 350 U.S. 359 (1956), available here; United States v. Williams, 504 U.S.  36, 54-55 (1992), available here; Bank of Nova Scotia v. United States, 487 U.S. 250, 261 (1988), available here; United States v. Calandra, 414 U.S. 338, 344-45 (1974), available here. Thus, according to the 11th Circuit, an indictment valid on its face is not subject to challenge on the ground that the grand jury acted on the basis of inadequate or incompetent evidence.  In other words, in the 11th Circuit a criminal defendant cannot challenge the governments position that assets are forfeitable if the evidence presented to the grand jury was sufficient for the grand jury to indict.

However, the 11th Circuits decision in Kaley II is in direct and express conflict with the 3rd, 8th, 2nd, and D.C. circuits.  The 11th Circuit recognized as such by stating that:

The Third and Eighth Circuits have held otherwise, concluding that a court must hold a full hearing at which “the government must demonstrate that it is likely to convince a jury, beyond a reasonable doubt, . . . that the defendant is guilty of [the statutory violation] and . . . that the profits or properties at issue are subject to forfeiture.” United States v. Long, 654 F.2d 911, 915 (3d Cir. 1981), available here; United States v. Lewis, 759 F.2d 1316, 1324 (8th Cir. 1985) (following Long), available hereSee also United States v. Monsanto, 924 F.2d 1186 (2d Cir. 1991) (en banc), available here. The 11th Circuit also stated that:  “The D.C. and Ninth Circuits, like the Second Circuit in Monsanto, have held that the postrestraint hearing must address whether there is probable cause to believe that the defendant is guilty of the crime that makes the assets forfeitable. United States v. E-Gold, Ltd., 521 F.3d 411, 419 (D.C. Cir. 2008); United States v. Roth, 912 F.2d 1131, 1134 (9th Cir. 1990)” available here.

Judge Edmondson, like Judge Tjoflat before him, authored a concurring opinion, see slip op. at 30, and remarked that: “I concur in todays result. I concur because I cannot say with strong confidence that my colleagues on the panel are incorrect in the way they see the law working. But I concur with deep doubts. And if I were deciding the case alone, I expect I would reach a different result and write something largely in line with United States v. Monsanto, 924 F.2d 1186 (2d Cir. 1991) (en banc), and United States v. E-Gold, Ltd., 521 F.3d 411 (D.C. Cir. 2008).”  Judge Edmondson continued:  “I have voiced my doubts, but I cannot firmly conclude that the legal position my experienced, able colleagues have taken is definitely erroneous. Therefore, I do not dissent, although I am uneasy that the limits that we set today for the hearing essential to continue a pretrial restraint on property might well be too limiting under the Constitution.”

The takeaway from Kaley I and Kaley II, is that, as it currently stands, a criminal defendants ability to contest pretrial the governments use of the federal forfeiture statute is limited, but varies from circuit to circuit.  As the concurring opinions in Kaley I and Kaley II demonstrate, there is a clear circuit split, one which appears will have to be settled by the U.S. Supreme Court.  Also the concurrences in Kaley I and Kaley II show the good possibility that the 11th Circuit may be willing to re-examine its position by the full (en banc) court. 

The attorneys at Fuerst Ittleman, PL have extensive litigation experience before the U.S. District Courts and the U.S. Circuit Courts of Appeal regarding criminal forfeitures.  You can contact us by calling 305.350.5690, or by emailing us at contact@fidjlaw.com.

Feds Winning Battle against Health Care Fraud

By: Merrill Goozner
December 15, 2011

12142011_Healthcare_Frauds_inline

Federal prosecutors brought a record number of cases of health care fraud in fiscal 2011, a new report said, with Florida and its huge Medicare-dependent population remaining the epicenter of fraudulent claims.

The latest data, drawn from federal records by the Transactional Records Access Records database at Syracuse University, showed total prosecutions jumped 68.9 percent to 1,235 cases compared to 2010, a record increase.

The huge increase was fueled largely by a sharp jump in cases brought in Puerto Rico, where prosecutors charged 548 defendants with health care fraud last year, up from just 119 the previous year. Most of those were minor cases. But even without the Puerto Rican cases, fraud prosecutions nationwide were up sharply and reached the highest level since 2000.

Miami led the nation in activity, accounting for nearly one out of every nine health care fraud prosecutions, followed by Houston. Together, federal prosecutors in those two districts accounted for over one out of every five health care fraud prosecutions.

“The good news is there’s lots of prosecutions. The bad news is there’s
lots of prosecutions.”

The Obama administration stepped up its enforcement activity in late 2009 with the creation of tasks forces in nine cities to root out Medicare and Medicaid fraud. “They’re really going after these cases very aggressively, and I think you’ll see prosecutions increase even more over the next few years,” said Louis Saccoccio, chief executive officer of the National Health Care Anti-Fraud Association, which was launched in 1985 by insurers to help root out both private and public sector fraud in the industry.

“The good news is there’s lots of prosecutions,” he said. “The bad news is there’s lots of prosecutions. The real question is what will CMS (the Center for Medicare and Medicare Services) do to prevent these frauds from taking place in the first place.”

A typical case concluded in Trenton last week when a federal judge sentenced a former senior manager of Columbia, Md.-based Maxim Health Care Services, one of the nation’s leading home health care providers, to five months in prison for setting up a phony office that billed Medicaid and the Veterans Administration nearly a million dollars. The criminal charges were part of a nationwide investigation of Maxim that led in September to an out-of-court settlement where the firm – to avoid a conviction that might have disqualified it from the programs – agreed to pay the government $150 million in criminal and civil penalties.

Experts and even defense attorneys say health care fraud, estimated to cost the government $70 billion a year, won’t be curbed until the government figures out how to short-circuit schemes through better monitoring of claims before they are paid and better screening of firms before they are allowed to sell services to the programs. Last June, CMS launched a data-mining program that will review Medicare claims before payment to identify individual providers that show huge spikes in activity. “CMS is on the right track,” Saccoccio said.

“They have to blow up the bill now, investigate later system,” agreed Andrew Ittleman, a white collar criminal defense attorney at Fuerst Ittleman in Miami. While he says that many cases involve companies in legitimate billing disputes with the government, he agreed “it’s not at all misguided given the size of the problem and the magnitude of the fraud.”

“The more sinister cases down here involve people who set up broom closets without an address and bill Medicare as long as they can before they high-tail it to Cuba or wherever in Latin America,” he said. “Magistrates aren’t even giving pre-trial release to some of these defendants because we don’t have an extradition treaty with Cuba.”

To view original article, click here.

Mistrial Declared in Foreign Corrupt Practices Act Case After Jury Could Not Reach Verdict

On Thursday, July 7, 2011, U.S. District Judge Richard Leon of the District of Columbia declared a mistrial in a criminal foreign bribery case under the Foreign Corrupt Practices Act (“FCPA”) involvingallegations of a corrupt deal to sell $15 million in supplies to Gabon’s Ministry of National Defense.  Prosecutors from the Department of Justice alleged that defendants John Wier III, Pankesh Patel, Lee Allen Tolleson and Andrew Bigelow tried to bribe Gabonese officials to win contracts. 

The government built its case through an undercover operation where undercover FBI agents met with the defendants and purportedly agreed to participate in the illegal deal. The case is significant because the four individuals are the first to go to trialoutof 22 military and law enforcement equipment industry executives arrested in July 2010 as part of an FBI sting. This case marked the first large-scale use of undercover techniques, commonly seen in drug or fraud cases, in an FCPA bribery investigation and it is the largest prosecution of individuals since the government began enforcing the FCPA over 30 years ago. 

The purpose of the Foreign Corrupt Practices Act is to make it unlawful for certain classes of U.S. persons and entities to make payments to foreign government officials to assist in obtaining or retaining business. Specifically, the anti-bribery provisions of the FCPA prohibit any willful or corrupt offer, payment, promise to pay, or authorization of the payment of money or anything of value to any person, while knowing that such money or thing of value will be offered to a foreign official to influence the foreign official in his or her official capacity to do an act in violation of his or her lawful duty, or to secure any improper advantage in order to assist in obtaining or retaining business.

Throughout the trial, the defense focused on and impeached the credibility of the prosecution’s top informant, to show the jury that he was unreliable and unsavory.  Richard Bistrong, the informant who helped carry out the FBI’s sting operation, had his own history of past bribery crimes, among other assorted wrongdoing. 

The jury began deliberations on June 28, and on July 7, indicated that it was “hopelessly deadlocked.”  As a result, the judge declared a mistrial, meaning no verdict; however, the prosecution intends to retry the case against all four defendants in front of a different jury. This case is an example of the energized enforcement of the FCPA, in support of which the government is willing to employ undercover operatives to engage in sting operations to sniff out violations of the FCPA. So far, although it engaged in these new investigative tactics, and despite having taken the case to trial, the government was not able to obtain convictions.

Andrew Ittleman of Fuerst Ittleman to Instruct at 2011 US Money Transmitter Seminar in Los Angeles

On April 14 and 15, 2011, Andrew Ittleman, Esq. CAMS of Fuerst Ittleman will participate as an instructor at the US Money Transmitter Seminar at the Hotel Intercontinental in Los Angeles, California. The Seminar, which will be held as part of the 2011 International Money Transmitter Conference (IMTC), will be the first of its kind in California and will feature intensive discussions on a variety of issues affecting the money transmitting industry. The Seminar is intended to give an in-depth overview of the most important US money transfer regulations as well as the interpretations and expectations of US authorities regarding such regulations. Using examples drawn from real life, participants will receive practical advice on how to implement proper actions to prevent costly mistakes and avoid litigation risks. Among other issues, the Seminar will address the following questions:

  • What is a money transmitting business? Are you sure you are one? Are you sure you are not?
  • If you have a bank account in a state in the US, is your business required to become licensed there?
  • If you have corporate headquarters in a state, is your business required to become licensed there?
  • If you have a license to transmit money in one state, what types of activities can you conduct in other states where you are not licensed?
  • Can a foreign money transmitting business maintain bank accounts in the United States if the business is unregistered or unlicensed in the United States? Does it have to register with FINCEN?
  • Why are criminal investigations and prosecutions uniquely devastating for money services businesses?

For more information about the conference, please visit IMTC’s website. Additionally, Fuerst Ittleman clients and colleagues are entitled to a $100 discount off the cost of registration. For more information, please see the following announcement from IMTCs Director, Mr. Hugo Cuevas-Mohr:

Hugo Cuevas Letter [PDF]

Judge Agrees Agency for Health Care Administration Rule Goes Beyond Regulatory Powers

On July 23, 2010, Administrative Law Judge Eleanor M. Hunter entered a Final Order in the case of Las Mercedes Home Care Corp v. Agency for Health Care Administration. The Order declared invalid a rule requiring Medicaid providers of home health agencies to issue either W-2 or 1099 tax forms to individuals on their staffs.

Las Mercedes is a licensed home health agency in Florida and was an enrolled Medicaid provider of home health services from July 1, 2004 through June 30, 2006. The company works with patient physicians to determine the type and scope of home health services needed and arranges for such services to be provided through one of 22 companies with which it maintains staffing agreements.

The suit began in response to a September 30, 2008, Final Audit Report issued by ACHA which sought $878,843.93 in Medicaid overpayments and a fine of $1,000. Soon afterwards, Las Mercedes requested an administrative hearing and the case was referred to the Division of Administrative Hearings (DOAH) in November and set for hearing in February. Following numerous continuations, the AHCA Motion to Amend Final Audit Report was granted on June 24, 2009.

After additional discovery, Las Mercedes filed a Motion to Dismiss arguing that the AHCA rule requiring that Medicaid home health agencies issue W-2 or 1099 forms to individuals conflicted with Statutory authority. In response to an AHCA objection to consideration of the validity of the rule, Las Mercedes filed a rule challenge case; the two cases were then consolidated.

The challenged rule is a provision from the Florida Medicaid Home Health Services Coverage and Limitations Handbook, which has been incorporated by reference by Florida Administrative Code Rule 59G-4.130. The rule requires Home Health services to be provided by professionals who are directly employed by or under contract with a home health agency enrolled in Medicaid Home Health Services program and provides, “Employed or contracted means that the home health agency provides a W-2 of 1099 tax form for the individual.”

Attorney Andrew Ittleman of Fuerst Ittleman, on behalf of Las Mercedes, alleged that the Rule was an invalid exercise of AHCA authority because it (1) went beyond AHCAs powers, (2) contradicted the Florida Statute 400.463(9) definition of “employed by or under contract with” and (3) was arbitrary and capricious.

After determining that the DOAH had jurisdiction to determine the validity of Medicaid rules, the court found that none of the purported statutes authorized AHCA to regulate the business relationship between a home health agency and its employees or contractors. Accordingly, the Court held that the Rule goes beyond the scope of AHCA powers.

The court then found that the “direct employee” definition provided in Section 400.462(9), which includes, “an employee for whom a management company that has a contract to manage the home health agency on a day-today basis…” contradicted and precluded the AHCA definition of the same term. Further, there was no indication that the Legislature or federal government had intended for the AHCA to create its own more restrictive definition.

Finally, the court ruled that the additional requirement under the AHCA Rule was an irrational and illogical methodology for ensuring health, safety, and welfare, and curbing fraud, waste, and abuse. Thus, the court voided the rule established on page 1-8 of the Florida Medicaid Home Health Services Coverage and Limitations Handbook as an invalid exercise of delegated legislative authority.

For more information regarding the AHCA, Medicaid, or administrative agency regulations please contact us at contact@fidjlaw.com.

Hunton & Williams delays record disclosures in Stanford case

By: Paul Brinkmann
October 19, 2009

Attorneys at one of Miami’s largest law offices are waiting for a Texas judge to rule on whether they should be forced to turn over records of their work for accused Ponzi schemer R. Allen Stanford.

Carlos Loumiet, Miami-based attorney for Hunton & Williams, helped Stanford set up a special trust office to move millions of dollars to Antigua before the SEC shut down Stanford International Bank earlier this year.

Hunton & Williams has agreed to turn over records related to Stanford’s U.S. operations and some limited files about representing Stanford personally, but it is fighting the request for records about Stanford operations based in Antigua.

Attorneys for Stanford receiver Ralph Janvey said Hunton & Williams’ refusal to turn over certain records has “jeopardized” the ability to recover and preserve assets for victims of the alleged scheme.

Kevin Sadler, of the Baker Botts law firm in Austin, Texas, represents the receiver.

In March, Hunton & Williams’ general counsel, Robert Rolfe, wrote to Sadler, saying that the law firm believes U.S. federal courts lack jurisdiction over the Antiguan companies, and that a receiver in Antigua may have jurisdiction.

Loumiet was in Greenberg Traurig’s Miami office when he began working for Stanford in the late 1990s.The Miami Herald reported Greenberg Traurig is being drawn into the investigation.

Loumiet, Greenberg Traurig and Hunton & Williams have not responded to the Business Journal’s request for interviews about the Stanford case.

In correspondence attached to court filings, Rolfe said Hunton & Williams maintains all the work it did for Stanford was “legal work.”

Janvey could be looking for law firm records for several reasons, said Andrew Ittleman, a partner with Fuerst Humphrey Ittleman in Miami who specializes in anti-money laundering law. The receiver probably just believes the records could help him investigate Stanford’s operations, he said, and is trying to determine if firms that advised a defunct company could be relief defendants.

“It’s more likely the firms are also victims of Stanford’s,” he added, noting lawyers should recognize illegal schemes if they work for one long enough.

To view original article, click here.

Mitchell S. Fuerst, Esq., and Andrew S. Ittleman, Esq.,

Mitchell S. Fuerst, Esq., and Andrew S. Ittleman, Esq., C.A.M.S. will speak at the International Money Transmitters Convention on November 15–16, 2007 at the Bahia Mar Beach Resort, 801 Seabreeze Blvd., Fort Lauderdale, FL

Link : https://www.nmta.us/portal/page.php?47

Additional information:

The panel : Ask the Experts: Money Transmitters and Money Laundering Prosecutions for The Defense:
– George Brown, Merle, Brown & Nakamura P.C.
– Sam Rosenthal, Curtis, Mallet-Prevost, Colt & Mosle LLP
– Mitchell Fuerst, Fuerst Ittleman
– Andrew Ittleman, Fuerst Ittleman

The IMTC is being organized by the National Money Transmitters Association www.nmta.us in cooperation with the Florida International Bankers Association (FIBA). Anyone who has an interest in the money transfer industry will benefit and is invited to attend, including not only transmitters and their employees, but also agents, bankers, credit unions, micro-finance institutions, professional service providers, folks from all related MSB industries, and government officials.