PDF Bloomberg Businessweek Jan 2, 2011

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Politico, February 15, , How to fix the mortgage mess , with Glenn Hubbard. The Washington Post, February 6, , Foreclosure deal doesn'g go far enough, some groups say. International Herald Tribune, February 1, , US to scrutinize investments by Freddie Mac; Treasury to investigate mortgage finance giant's bets against homeowners.

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The Washington Post, October 19, , How much would mass refinancing do for th economy? Housing Wire, September 14, , Senate hears hidden risk of major refinancing plan.

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Housing Wire, September 9, , O bama refinancing plan problematic, but possible , with Glenn Hubbard. Pfizer Inc. The settlement has not yet been finalized, and is subject to change. Other Notable Settlements and Judgments. Online giant Google, Inc. Google allegedly was made aware of the problem as early as , but failed to resolve it. Ranbaxy Laboratories Ltd. The FDA accused Ranbaxy in of falsifying data and rest results, and halting review of certain medications.

The DOJ alleged that Ranbaxy lied about the ingredients and formulations in some of its products. In , Merck was charged with offering Vietnamese doctors kickbacks for prescribing PegIntron, and in , Merck settled a claim involving off-label marketing of PegIntron; the current inquiry appears to be unrelated to the prior investigations. The DOJ also issued a subpoena to Merck requesting information about the marketing of the heart drug Integrilin and the antibiotic Avelox.

Separately, the DOJ issued a civil investigative demand to Inspire Pharmaceuticals, which Merck acquired in May , in connection with alleged off-label uses of the drug AzaSite. Cephalon received a subpoena from the U. Cephalon is currently operating under a corporate integrity agreement from a settlement of an investigation into off-label promotion of several of its medications, including the wakefulness drug Provigil.

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HHS has served a subpoena on North Broward for documents related to contracts between North Broward and more than 27 physicians. CardioNet received a civil investigative demand from the DOJ relating to allegations that the company used inappropriate codes with respect to Medicare claims for its heart-monitoring services.

The demand was issued in the course of an investigation under the False Claims Act and seeks documents that date back to Health Management Associates, Inc. The original lawsuit was filed by a qui tam whistleblower. The defendants face charges of falsely billing Medicare for treatments that did not occur or were medically unnecessary. The defendants are charged with various health care related crimes, including conspiracy to defraud Medicare, health care fraud, violations of the Anti-Kickback Statute, and money laundering.

The falsification of these records was used by those charged in these schemes to justify services that were unapproved or medically unnecessary. Other Notable Investigations and Actions. Forest Laboratories received a document subpoena from the U.


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The investigation focuses on five marketed drugs and an experimental compound. The government alleges that Guidant sold cardioverter defibrillators even though it knew those devices were defective, and hid the problems with those devices from patients, doctors, and the FDA. The lawsuit originated from a quit tam whistleblower suit brought by a patient who allegedly received one of the defective devices.

Boston Scientific Corp.

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The vast majority of those collections were in the health care industry. This is more recovered under the Act than in any other three-year period. These settlements show that HHS will no longer let offending corporations pay and move on; instead, HHS is demanding expensive post-settlement monitoring. These settlements related to a wide array of alleged health care compliance violations, including misbranding of drugs, off-label marketing, kickbacks to physicians, kickbacks to pharmacists, and improper billing of Medicare and Medicaid.

In , government prosecutors continued the trend of increased enforcement actions against individuals, including health care industry executives. Though prosecutors have traditionally declined to seek criminal liability for corporate officials, the government has indicated that trend is changing. Individuals convicted under the Park Doctrine are subject to criminal fines, disbarment by the FDA, and exclusion from participating in federal health care programs. Under the new criteria, relevant factors the FDA will consider in determining whether or not to recommend a Park Doctrine indictment include:.

Prosecutors had some ground-shifting wins against individual defendants, including the sentencing of four former Synthes Inc. However, in August , HHS announced that it would not pursue the exclusion. In , U. The Physician Payments Sunshine Act, enacted in as Section of the PPACA [93] , requires that, beginning on January 1, , health care companies track all cash, in-kind items or services, stocks, consulting fees, honoraria, gifts, entertainment, travel, meals, education research, charitable contributions, royalties, ownership interests, grants, and many other benefits provided to physicians.

Beginning on March 31, , companies will be required to make annual public reports of such payments, with a searchable database available as of September 30, Fines for failure to comply—whether intentional or not—are severe. The nature of these disclosures, however, is not uniform, as the companies currently disclosing this information use varying minimum thresholds and report different types of fees and expenses. The Sunshine Act, however, should bring much-needed uniformity to these disclosures.

When CMS missed its October 1, deadline to provide rules for manufacturers, Senators Charles Grassley and Herb Kohl pressed CMS to come forward with regulations, asked why CMS had failed to meet the statutory deadline, and requested a timeline for establishing the regulations. The rule proposed by CMS was finally made public on December 19, Perhaps most importantly, the proposed rule declared that companies need not collect information required under the Sunshine Act beginning on January 1, Instead, companies need to begin to do so only 90 days after the publication of the final rule.

As expected, the rule proposes the requirements for the content and organization of payment reports. The rule also would require manufacturers to maintain books and records to enable an audit for compliance with the law, for at least five years. Additionally, the proposed rule would expand the definition of an applicable manufacturer to encompass any company that manufactures a covered product for sale in the U.

Senator Charles Grassley of Iowa, the ranking Republican on the Senate Committee on Finance, which has jurisdiction over the Medicare and Medicaid programs, has focused a great deal of attention over the past few years on the relationships between physicians and the health care industry. Naturally, he has also been active in pushing for its expeditious implementation, as described above.

Senator Grassley has repeatedly spurred legislative investigation of various financial arrangements in the health care arena by capitalizing on media reports and other sources of information identifying potential conflicts of interest. We expect these efforts to continue gaining steam, as the codification under the PPACA may alter norms with respect to disclosures, and increase the scrutiny and investigation of additional types of financial arrangements going forward.

Indeed, he has also led the charge in various other areas related to health care compliance. For example:. IMS Health Inc. For example, in United States v. The Second Circuit has requested additional briefing in light of the Sorrell decision, and has not yet issued a decision. However, Allergan dropped its suit as part of its off-label settlement and guilty plea with the DOJ for off-label marketing of Botox. At a minimum, these suits are likely to result in decisions that provide additional guidance regarding appropriate behavior and restrictions surrounding marketing practices.

Given the tremendous scrutiny given to off-label marketing, and the value of fines paid for violation of those rules, we expect continued and increased focus by industry in attempts, including those based on the First Amendment, to reign in government enforcement in this area. In Pliva v.

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Writing for the majority, Justice Clarence Thomas acknowledged that, for consumers, it would make little sense that brand-name manufacturers could be sued for the labels on their products while generic drug-makers could not be sued for identical labels, but that result was required by the law. In dissent, Justice Sonia Sotomayor pointed out that whether a harmed consumer can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug.

In other words, if a plaintiff is harmed by a generic drug, but its labeling suit against the generic manufacturer is preempted because the generic manufacturer was required to copy the label of the brand manufacturer, the plaintiff cannot bring suit against the brand manufacturer, whose products it did not use. With the Supreme Court granting certiorari to the constitutional challenge to the PPACA by 26 states, the outlook of some recent areas of reform—including the disclosure rules of the Sunshine Act—is uncertain. Professional Development Technology Education. George Off Campus Maps.

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