Ex-hedge fund trader charged in $276M insider ploy

NEW YORK (AP) — A former hedge fund portfolio manager was arrested Tuesday in what prosecutors called perhaps the most lucrative insider trading scheme of all time — an arrangement to obtain secret, advance results of tests on an experimental Alzheimer’s drug that netted more than $ 276 million for his fund and others.

The case also led authorities to investigate the activities of one of the nation’s wealthiest hedge fund managers, billionaire Steven A. Cohen.

The portfolio manager, Mathew Martoma, was accused in U.S. District Court in Manhattan of using the information to advise other investment professionals to buy shares in the companies developing the drug, then later to dump those investments and place financial bets against the companies when the tests returned disappointing results.

“The charges unsealed today describe cheating coming and going,” U.S. Attorney Preet Bharara said at a news conference. The scheme unfolded “on a scale that has no historical precedent.”

Martoma’s trades helped reap a hefty profit from 2006 through July 2008, while he worked for CR Intrinsic Investors LLC of Stamford, Conn., an affiliate of SAC Capital Advisors, a firm owned by Cohen.

Cohen is not referred to by name in court papers but is frequently alluded to for his dealings with the defendant in the weeks leading up to an announcement about the drug trial.

The government has been scrutinizing SAC since at least November 2010, when the FBI subpoenaed SAC and other influential hedge funds. Martoma is the fourth person associated with SAC Capital to be arrested on insider trading charges in the last four years.

SAC spokesman Jonathan Gasthalter said the company and Cohen “are confident that they have acted appropriately and will continue to cooperate with the government’s inquiry.”

The FBI said the scheme developed after Martoma met a doctor in Manhattan involved in an Alzheimer’s drug trial in October 2006. According to a criminal complaint, he later obtained confidential information related to the final results of a drug trial.

Martoma’s attorney, Charles Stillman, called his client “an exceptional portfolio manager who succeeded through hard work and the dogged pursuit of information in the public domain. What happened today is only the beginning of a process that we are confident will lead to Mr. Martoma’s full exoneration.”

Martoma was arrested at his home in Boca Raton, Fla., and made an initial appearance in federal court in West Palm Beach, Fla., where he was released on $ 5 million bail on charges of conspiracy to commit securities fraud and securities fraud. He was scheduled to return to court Monday in Manhattan.

The defendant will have great incentive to cooperate with the government because the size of the gains would add years, if not decades, to any potential sentence upon conviction, said John Sylvia, co-chairman of the securities litigation practice at the Mintz Levin law firm in Boston.

He said it was clear from reading the court papers that Cohen was referenced frequently and was a likely target of investigators, though they might not be able to build a sufficient case against him.

“There’s little doubt as to where the government’s sights are,” Sylvia said. “I don’t think it takes Sherlock Holmes to figure it out.”

The Securities and Exchange Commission filed civil papers in the case against CR Intrinsic Investors, Mathew Martoma and Dr. Sidney Gilman. The civil complaint said the illegal money was earned in July 2008, when various hedge funds traded ahead of a negative public announcement involving the clinical trial results of an Alzheimer drug being jointly developed by Elan Corp. and Wyeth, both pharmaceutical companies.

The SEC complaint said that Martoma carried out the scheme with Gilman, an 80-year-old professor of neurology at the University of Michigan Medical School who served as chairman of a safety committee overseeing the clinical trial. Gilman was selected by Elan and Wyeth to present the final clinical trial results at a July 29, 2008, medical conference.

Messages left with the University of Michigan Medical School were not immediately returned.

Gilman’s lawyer, Marc Mukasey, said his client is cooperating with the SEC and the U.S. Attorney’s Office, and has entered into a non-prosecution agreement with federal prosecutors.

A copy of the agreement released by federal prosecutors Tuesday showed that Gilman will forfeit nearly $ 187,000 that he received from Elan for consulting work in 2007 and 2008 and from an expert networking firm for consultations between 2006 and 2009 with Martoma’s hedge fund.

Bharara said Martoma gained from “cultivating and corrupting” Gilman, eventually receiving $ 9 million in bonus pay for the year when the trades were made.

Martoma met with the doctor about 42 times, beginning in the summer of 2006, and eventually convinced him to start talking about the drug trial, prosecutors said.

The SEC said leaks by Martoma caused hedge fund portfolios managed by CR Intrinsic and by an affiliated investment adviser to liquidate more than $ 700 million in holdings in Elan and Wyeth.

The massive repositioning, the SEC said, allowed CR Intrinsic and various hedge funds to reap huge illicit profits and avoid steep losses.

“By cultivating and corrupting a doctor with access to secret drug data, Mathew Martoma and his hedge fund benefited from what might be the most lucrative inside tip of all time,” Bharara said.

The prosecutor said the doctor sent him a draft of the 24-page presentation he planned to make at a conference announcing the results.

That is when Martoma “had to do a spectacular about-face because he understood that — with these negative results looming — the hedge fund’s massive $ 700 million stake had become a terrible bet,” Bharara said. “And so, just like that, overnight, Martoma went from bull to bear as he tried to dig his hedge fund out of a massive hole.”

The news caused Elan’s stock price to plunge by more than 40 percent. The price of Wyeth fell about 12 percent.

The bets against the drug developers brought additional profits totaling $ 76.2 million. That is roughly the same amount that prosecutors said former hedge fund manager Raj Rajaratnam made in illegal profits before he was arrested. The one-time billionaire is serving an 11-year prison sentence in what was once considered the biggest insider trading case in U.S. history.

A year later, a hedge fund employee recommended that Martoma be terminated, and he was let go in 2010, Bharara said.

___

AP Business Writer Daniel Wagner in Washington contributed to this report.

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U.S. fiscal impact of great concern to Canada: Canada’s Harper

TORONTO (Reuters) – Any fiscal problems that would significantly slow the U.S. economy would be of great concern to Canada, Canadian Prime Minister Stephen Harper said on Monday.

The United States needed a credible medium-term fiscal plan, Harper said at a business forum in Ottawa, adding that he was following the U.S. fiscal debate with “great interest.”

(Reporting by Solarina Ho)

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Intel CEO Paul Otellini to retire in surprise move

SAN FRANCISCO (AP) — Intel CEO Paul Otellini dropped a bombshell on the company’s board of directors last week, telling them in private that he plans to retire from the world’s largest maker of microprocessors in May. Otellini‘s move comes at a time when Intel faces a shaky economy and a mobile gadget craze that is eating away at demand for its PC chips —and it gives the company just six months to find a new leader.

Intel‘s board expected the 62-year-old Otellini to remain chief executive until the company’s customary retirement age of 65. The company announced his impending departure on Monday.

“The decision was entirely Paul’s,” said Intel spokesman Paul Bergevin. “The board accepted his decision with regret.”

Otellini will be ending a nearly 40-year career with Intel, including an eight-year stint as CEO by the time he leaves. He joined the Santa Clara, Calif. company after graduating from the nearby University of California at Berkeley and worked his way up the ranks before succeeding Craig Barrett as CEO in May 2005.

“It’s time to move on and transfer Intel‘s helm to a new generation of leadership,” Otellini said in a statement.

In another statement, Intel Chairman Andy Bryant praised Otellini for leading the company through “challenging times and market transitions.”

Intel‘s board plans to consider candidates inside and outside the company as it searches for Otellini’s successor. Otellini will be involved in the search.

Otellini and the four other men who have been Intel‘s CEO during the company’s 45-year history have all been promoted from within. The company’s board is believed to be leaning in that direction again.

Intel identified the leading internal candidates Monday by anointing three of Otellini’s current lieutenants as executive vice presidents. They are: Renee James, head of Intel‘s software business; Brian Krzanich, chief operating officer and head of worldwide manufacturing; and Stacy Smith, chief financial officer and director of corporate strategy.

If recent history is any indication, Krzanich has the inside track to become Intel‘s CEO. Both Barrett and Otellini served as chief operating officer before becoming CEO.

Although Otellini is generally well regarded, he has faced criticism for initially underestimating the impact that smartphones and tablet computers would have on the personal computer market. It was a pivotal change that also confounded Microsoft Corp. CEO Steve Ballmer, whose software company makes the Windows operating system that runs most of the PCs relying on Intel‘s chips.

“The shift came more quickly than they expected, and when they did finally see what was happening, they were a little late to react,” said technology analyst Patrick Moorhead of Moor Insights & Strategy.

Indeed, in 2008, nearly 300 million PCs were sold and most of them were powered by Microsoft‘s Windows and Intel‘s microchips, according to Forrester Research. Some 142 million smartphones sold that year, at a time when the tablet market hadn’t really taken off. That wouldn’t happen until Apple‘s 2010 release of the iPad.

By contrast, this year, Forrester estimates 330 million PCs will be sold worldwide compared with 665 million smartphones and just over 100 million tablets. By 2016, Forrester predicts annual sales of PCs will rise only slightly to 370 million machines while more than 1.6 billion smartphones and tablets will be purchased.

The fates of Intel and Microsoft have been so tightly wound for the past 30 years that computers using a combination of their chips and software are famously known as “Wintel” machines.

Now, much of the technology industry is questioning whether Intel and Microsoft can catch up in the mobile market to ensure their products remain as essential — and profitable — in the future as they have been in the past three decades.

It’s a challenge that Ballmer, 56, is confident he can tackle. He signaled his intent to remain Microsoft‘s CEO earlier this month when he ushered out the head of the company’s Windows division because of philosophical differences over the company’s future direction. For whatever reasons, Otellini concluded it was time for new leadership at Intel — an opinion that many investors share, according to RBC Capital Markets analyst Doug Freedman.

“A shift in leadership could be welcome news to investors as Intel could be in greater position to broaden its portfolio into higher growth markets,” Freedman wrote in a Monday research note.

Intel‘s stock was unchanged at $ 20.19 shortly before the market closed Monday. The stock has fallen more than 20 percent during Otellini’s reign. Most of the decline occurred this year amid concerns about the company’s ability to adjust to mobile computing and weakening demand for its core products in countries with troubled economies, particularly in Europe and China. The company blamed the poor economy for a 14 percent drop in its earnings during its most recent quarter.

Intel‘s chips have become even more dominant in the PC computer market during Otellini’s tenure, helping to boost the company’s annual revenue from $ 39 billion in 2005 to $ 54 billion last year. Besides supplying Windows-powered PCs, Otellini also scored a coup in 2006 when he convinced Apple to start using Intel chips in Mac computers instead of IBM Corp.’s microprocessors.

But Apple‘s pioneering work in smartphones and tablet computers also muddled Intel‘s future. Both the iPhone and iPad inspired a wave of sophisticated handheld devices that are undercutting demand for desktop and laptop machines that house Intel processors.

Most tablets rely on a technology licensed from British chip designer ARM Holdings Plc. Even Microsoft has tweaked the latest version of the Windows operating system so it works on ARM chips.

Other chip makers such as Qualcomm Inc. have developed less expensive microprocessors that have eclipsed Intel in the smartphone market. Qualcomm‘s inroads in the mobile market are a key reason why its stock has soared by more than 70 percent while Otellini was running Intel.

The contrasting performances of the two companies’ stocks enabled Qualcomm to surpass Intel as the world’s most valuable chip maker. Qualcomm‘s market value now stands at about $ 106 billion versus $ 100 billion for Intel.

Even though its stock under Otellini has lagged the rest of the market, Intel‘s ongoing prosperity has enabled the company to reward shareholders in other ways. Intel has paid stock dividends totaling $ 23.5 billion under Otellini as its quarterly payments rose 8 cents per share in 2005 to 22.5 cents per share currently.

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Mitt Romney a Twihard? Candidate and Wife Take in “Twilight” Finale

LOS ANGELES (TheWrap.com) – He may have missed out on becoming leader of the free world when he lost the election to President Obama, but Mitt Romney is keeping busy – with the romantic vampires and werewolves of “Twilight.”

Saturday night, he was spotted with his wife Ann heading into a showing of “Twilight Saga: Breaking Dawn – Part 2″ at a cineplex in Del Mar, Calif., by TMZ. After the movie, they and two young men went to a nearby pizza place, where they reportedly spoke and posed for pictures with patrons.

The Saturday night out for the Romneys was in contrast to the recent movie-viewing by the man who beat him in the election. President Obama last week viewed Oscar hopeful “Lincoln” in a special White House screening with several of the cast members and filmmakers.

There was no word on whether Romney or his wife aligned with Team Edward or Team Jacob.

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A Short To-Do List for Intel’s Next CEO

With Paul Otellini heading in May to the nearest 18-hole course, speculation is rampant about who will replace him. That’s a parlor game this post isn’t going to get into (although you can see a good roundup of likely candidates here). But no matter who gets the job, the new chief executive officer of Intel (INTC) has a refreshingly brief and direct list of priorities for the months and years ahead.

Evercore analyst Patrick Wang put it best: “Intel’s new CEO has one task and one task only,” he said. “Succeed in mobile.”

There’s no doubt that Otellini has fulfilled Intel’s primary objective of dominating PCs and laptops. Though Intel’s competitor, Advanced Micro Devices (AMD), proved an able (and at times, superior) rival, that marketplace has settled into a fairly stable picture, with Intel continuing to command nearly 80 percent of the processors in notebooks and desktops.

But in mobile, the chipmaker serves less than 1 percent of the market. There, Intel has ceded ground to designs from British chip designer ARM (ARM:LN). ARM chips are made by Samsung (005930:KS), Qualcomm (QCOM), Nvidia (NVDA), and others and are in just about every smartphone and tablet you can think of. Here, Intel has a steep hill to climb. “The new CEO’s job is to grow mobile market share to somewhere north of 25 percent,” says Patrick Moorhead, a former AMD executive and now an industry analyst. According to Moorhead, Intel is not lacking technologically. “After two failed attempts at developing a mobile processor,” he says, “Medfield [Intel's latest mobile processor] shows they can create a competitive mobile product.”

But a manufacturer also has to sell what it makes, and that’s where things can get a little tricky for Intel. For starters, you have Samsung, the dominant manufacturer in mobile. Samsung is also the world’s second-largest semiconductor manufacturer, so it’s going to continue making chips for itself. Apple (AAPL) takes up another big chunk of the mobile and tablet market: Its processors are designed in-house, but manufactured by Samsung.

That leaves Intel with the not-Samsung/not-Apple part of the mobile market to go after. But it’s not even this simple, because that territory is already being fought over by Qualcomm, Nvidia, and Chinese manufacturers such as Fuzhou Rockchip Manufacturing. “Those Chinese manufacturers can do things so cheaply to satisfy domestic Chinese demand, ” says Wang. “Even Qualcomm and Nvidia can’t touch them.”

Everyone who follows Intel knows it remains the company to beat when it comes to technology and manufacturing ability. The company’s new CEO can rest assured that those parts of the company are where they need to be. But the mobile market is so competitive, with so many new players, that having a great product is only half the battle.

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Turbulence on Cuba-Italy flight leaves 30 bruised

ROME (AP) — An airliner flying from Havana to Milan abruptly plunged some 1,000 meters (3,300 feet) when it hit unusually strong turbulence over the Atlantic on Monday, terrifying passengers and leaving some 30 people aboard with bruises and scrapes, airline officials said.

The flight continued to Milan’s Malpensa airport after the plane’s captain determined that it suffered no structural damage and two passengers who are physicians found no serious injuries, Giulio Buzzi, head of the pilots division at Neos Air, told Sky TG24 TV.

The ANSA news agency quoted bruised passenger Edoardo De Lucchi as saying meals were being served when suddenly there was “10 seconds of terror.” He recounted how plates went flying and some passengers not wearing seatbelts bounced about.

Buzzi had said that the drop measured some 3,000 meters (10,000 feet) in a cloudless sky. But Milan daily’s Corriere della Sera’s web site, quoting Neos official Davide Martini, later reported that the plane first bounced up some 500 meters (1,650 feet), then dropped some 1,000 meters (3,300 feet) to some 500 meters (1,650 feet) below the original altitude.

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Review: Wii U Filled With Potential

The Nintendo Wii turns six this month, making the video game system past its prime in console years. Nintendo and third-party developers have been slowly grinding Wii titles to a halt as all prepare for its successor, the $ 300 Wii U (say it with us, We-you), to launch today.

WATCH: Wii U Video Review

The latest Nintendo comes with a shiny new console and a shiny new GamePad tablet controller. (They may actually be a little too shiny, as the system and controller easily pick up smudges and fingerprints.) A mess of long cords also come with the system, including the Wii U’s power cord, the GamePad’s charger, the HDMI cord and the motion sensor’s long, thin cord.

The box is packed with contents, but also high expectations.

The Console
The GamePad controller, which we will get to in a second, is one of the biggest changes to the system, but there are a lot of other changes inside the actual console. With an IBM multi-core processor, 2GB of RAM, and an AMD Radeon graphics chip, a Nintendo console is capable for the first time of pushing along full HD, 1080p games on your HDTV. It connects to your HDTV via that aforementioned HDMI cord, which is kindly included in the box.

At least for a brief period we have a Nintendo with better internal organs than the Xbox 360 and Sony PlayStation, though not many expect that to last.

Of note, the graphics processor on the Wii U is far more advanced than its competition, but the computer processor has been hinted to be a little less powerful than both rivals. This means stronger graphics, but potential processing issues when more moving items are presented on screen.

The GamePad
Back to the main event — the Wii U’s GamePad controller. Nintendo’s latest toy takes the best aspects of the company’s top-selling handheld, the Nintendo DS, and has supersized them, putting a larger, 6.2-inch touchscreen in your hands. But that’s not all that is found in the controller. It also has a front-facing camera, stylus, dual analog sticks, an accelerometer and a gyroscope.

At 1.1 pounds the controller is easy to hold and very light. And while it is a bit wide, it is durable enough to avoid much damage when in the hands of an enraged 7-year-old. Yes, I slammed it on a carpeted floor a few times and it withstood the abuse.

There is only one GamePad included in the box and you can expect there to be fighting over it. At the moment, Nintendo isn’t selling GamePads separately, but that’s intentional; there are no games that support dual GamePad experiences at the moment.

Nintendo calls its one-pad approach “asymmetric gameplay,” where the person using the GamePad has a different role in how games are played, equivalent to being “it” in tag or the dungeon master in “Dungeons & Dragons.” For this role, what they see on the controller’s screen is sometimes completely different than what others see on the TV.

For instance, in “Nintendo Land‘s Animal Crossing: Sweet Day,” the person with the GamePad controls two characters while the person with the extra non-GamePad controller controls just one. The person using the GamePad sees their characters on the touchscreen, while the non-GamePad player sees theirs on the TV.

Nintendo is releasing a Pro controller with the Wii U for an extra $ 50. The controller looks very similar to the Xbox 360 controller, and while we do wish it was included for the $ 300 price, you don’t have to buy that controller if you want to add more players. That’s because your original Wii games and Wiimote controllers will work with the new system.

Nintendo sold 97 million Wii consoles in six years and plenty of Nintendo fans have stashes of iconic white wands sitting around the house. All those still in love with motion controls can rest easy, this move means all your past, present and future arm flailing will endure.

Word to the wise: if you haven’t already purchased WiiMotion Plus add-on accessories for your old Wiimotes, now is the time, they’re crucial for games like Zelda Battle Quest in “Nintendo Land.”

Since the Gamepad is wireless, it can be used when away from the TV, but not too far away. You can play a game on it while in another room in the house, but it needs to be in close proximity to the console. You’ll want to make sure you’re in close proximity to the charger, too. All that technology inside the Gamepad takes a hit on battery life; after four hours of continuous gameplay it begins to warn you of its need for juice.

The Games
In 2006, the Wii launched with “Wii Sports,” a game included in the box and built to demonstrate the capabilities of the system. “Wii Sports” was big on simplicity, utilizing just a few buttons and bit of stick waving, making it the ultimate casual gaming experience.

Today’s Wii U’s launch is complimented by “Nintendo Land,” a world that contains 12 mini-games in one. (It comes in the box with the $ 350 Deluxe Wii U version and costs $ 60 on its own.) Some games take advantage of the stylus while others require a mix of the analog sticks, motion capabilities, and the actual touchscreen. The variety is a great showcase but lacks the level of simplicity that made “Wii Sports” an instant hit.

If anything, the Wii U’s sampling of gameplay varieties will get you excited thinking what might be possible with the new hardware. Drawing with the stylus on your GamePad and seeing the end result on a TV screen is extremely satisfying. A possible “Mario Paint” meets “Draw Something” could be gigantic. My colleague Joanna Stern couldn’t get enough of flicking stars on the touch screen in “Takamaru’s Ninja Castle,” I could see a full game centered around that mechanic doing very well.

At launch, there are almost two-dozen titles with various degrees of GamePad integration, spanning almost every genre. It feels like there should be more that directly take advantage of the touchscreen, however. We will be reviewing these over the course of the week, but I will say the $ 60 New Super Mario Bros. U seems like a must-have, just to experience Mario in HD for the first time.

The Social and Media Capabilities
With the Wii U comes a broadening of the Nintendo Network, the structure that has allowed Nintendo 3DS players to compete with each other online. On the Nintendo Network, video chat is now available through the GamePad‘s front-facing camera.

Mii avatars are being more integrated than ever into games, you can expect to be the star of the game more often and to see your Miis interacting with those of your friends, sharing screenshots, messages and accomplishments.

Even with more social networking and revamped cooperative play, the focus of this system is bringing back single players and defining Nintendo as a brand for both social gatherings and “me time,” hence the “U” in Wii U. More “hardcore” single player games will be in the mix as well, reflected at launch with “Call of Duty: Black Ops 2″ and “Batman: Arkham City” availability.

Like the competing consoles, Nintendo is also making moves to bring media capabilities to the console with YouTube, Netflix, Hulu Plus, and Amazon Instant Video integration. Nintendo has also announced TVii, an interface that integrates with those Internet video services and your cable box, but it has been delayed until December.

The Bottom Line
On paper, the Wii U sounds like a simple win. Take Nintendo’s best-selling handheld, their best-selling system (Wii), the graphics of their competitors and mash that up with latest developments in tablet technology. And in many ways it is, combining the best of the last five years in an incredibly unique and well-designed package. That said, there’s a ways to go in terms of games that take advantage of the touchscreen, the GamePad’s battery life, and we really do wish another controller was included in the box.

Wii U has major potential and if Nintendo plays their cards right, the system can become a major player, especially once the media capabilities and game options are fully stocked. The second-generation Wii might not be as game-changing as the orginal, but it certainly is a lot of fun to play with.

Joanna Stern contributed to this review.

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Aussie rockers AC/DC’s music to be sold on iTunes

NEW YORK (Reuters) – AC/DC‘S entire catalogue, including 20 studio and live albums and three compilations will be available on iTunes for the first time worldwide, Columbia Records and Apple said on Monday.

Until now the Australian heavy metal group that was formed by two brothers, Angus and Malcolm Young, in 1973, had refused to put their music on Apple Inc’s online music store.

“AC/DC’s thunderous and primal rock and roll has excited fans for generations with their raw and rebellious brand of music, which also resonates with millions of new fans discovering AC/DC everyday,” Columbia Records and Apple, said in a statement announcing the deal.

“Their growing legion of fans will now experience the intensity of AC/DC’s music in a way that has never been heard before,” they added.

The group’s 1976 debut album “High Voltage,” its classic “Back In Black” and 2008′s “Black Ice” are among the albums available on iTunes.

All the of music has been mastered for iTunes and fans can download entire albums or individual songs.

(Reporting by Patricia Reaney; editing by Paul Casciato)

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Amid meningitis crisis, critics say Medicare may promote risky drug compounding

NEW YORK (Reuters) – With 34 deaths and 474 cases of fungal meningitis linked to tainted steroids from a Massachusetts compounding pharmacy, blame has fallen on everyone from the pharmacy to state and federal regulators. Now a new potential culprit has emerged: Medicare, which reimburses for almost all compounded drugs.

“Medicare’s reimbursement policy is certainly relevant in the government’s role in supporting purchases” of compounded drugs, Senator Richard Blumenthal told Reuters, referring to the customized medications meant to be prepared for an individual based on doctor directions.

Medicare is the federal health insurance program for the elderly and disabled. Because it is such a large player in healthcare policy, its coverage decisions have an outsized impact on the market.

As long as a physician has prescribed a compounded drug, Medicare as well as some private insurers cover it even if the Food and Drug Administration has approved a version of the drug from a pharmaceutical manufacturer.

In a letter sent on Monday to U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, the consumer advocacy organization Public Citizen charged that by paying for compounded drugs Medicare “created an economic environment that allowed large-scale drug production by compounding pharmacies to flourish.”

“Medicare played a role in fostering the widespread use of compounded drugs,” Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, said.

In reply, an HHS spokesman told Reuters that if the FDA finds that a company is producing compounded drugs in violation of the law, “Medicare will not reimburse for drugs produced in that facility.” But because the FDA’s authority over compounding pharmacies is severely limited, “we urge Congress to strengthen FDA’s authority to ensure these kinds of outbreaks do not happen again.”

In a letter to Medicare on Monday, Senators Debbie Stabenow, Al Franken, Dianne Feinstein and Blumenthal – all Democrats – also raised concerns about how compounded drugs are “reimbursed at the state and federal level.”

The senators cited a section of Medicare’s policy manual which explains how the program can deny payment for compounded drugs. In addition, they asked how Medicare works with the FDA “to determine which companies have received violations for mass compounding of drugs.”

Medicare pays for compounded medications mostly under what is called Part B, which covers drugs that patients cannot administer themselves, such as spinal injections and intravenous cancer drugs. “These medications are vital and often life-sustaining and should be covered in full,” said David Ball, a spokesman for the International Academy of Compounding Pharmacists.

Also weighing in on compounding on Monday, the Senate Committee on Health, Education, Labor, and Pensions asked all 50 state boards of pharmacy – which, rather than federal regulators, oversee compounding pharmacies – for information on “actions you have taken to address this meningitis outbreak.”

Specifically, the committee asked the boards whether they had reported problems with drugs from New England Compounding Center, the company that produced the tainted steroids, to the FDA, and whether they require compounding pharmacies to report whether they produce large volumes of drugs.

Although traditional pharmacy compounding is small-scale, producing one prescription for one specific patient at a time, the company that produced the tainted steroids in the meningitis outbreak manufactured thousands of doses for hundreds of patients at once, documents show.

OUT OF BUSINESS

The suspicion that Medicare’s payment policy encourages large-scale compounding has arisen in part because in the single instance when Medicare denied payment for an entire class of compounded drugs – respiratory medications used in special inhalers called nebulizers – the decision drove compounders out of that business.

At the time, Medicare said that because compounded drugs are not tested for safety and effectiveness, they have “the potential of putting a patient at increased risk of injury, illness, or death.”

The nebulizer-drugs decision came in 2007, after patient advocates led by Allergy & Asthma Network Mothers of Asthmatics argued to Medicare that the compounded nebulizer drugs had contamination and potency problems, said Sandra Fusco Walker, who led that effort.

That coverage decision “is absolutely relevant” to the question of Medicare’s support for compounding pharmacies, Blumenthal said, “because it reflects an awareness of this issue. Whether that should be a precedent for denying coverage of all such (compounded) drugs is a separate question.”

The Center for Medicare and Medicaid Services (CMS), which is part of HHS and runs the Medicare, regularly decides whether to cover diagnostic tests, medications, surgical procedures and other medical treatments. It bases those decisions on whether the intervention is “reasonable and necessary.” For drugs, that almost always means that the medication has received approval from the FDA.

“We believe that Medicare’s policy manual clearly establishes the agency’s authority to deny coverage for compounded drugs,” said Carome.

But he admits that the manual is “internally contradictory.”

In a section of the manual related to compounded drugs, CMS says that compounded drugs that have not received FDA approval – which describes essentially all compounded drugs – are excluded from Medicare coverage.

“If the FDA has not approved the manufacturing and processing procedures used by these (compounding) facilities, the FDA has no assurance that the drugs these companies are producing are safe and effective,” the manual adds.

But the same section also says that payment for such a drug does not stop unless CMS notifies the local carriers that it contracts with to process Medicare claims “that it is appropriate to do so.”

“Clearly, if compounded drugs weren’t covered to the extent they are, there wouldn’t be an economic environment that allows large-scale compounding to continue,” said Carome.

(Editing by Cynthia Osterman)

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Housing recovery gains traction

WASHINGTON (Reuters) – Home resales rose in October and a gauge of homebuilder sentiment climbed to a six-year high in November, signs of surprising vigor in the country’s still-struggling housing market.

The National Association of Realtors said on Monday that existing home sales climbed 2.1 percent last month to a seasonally adjusted annual rate of 4.79 million units, beating forecasts by Wall Street economists.

Separately, strengthening demand for new homes drove an increase in a monthly measure of home builder sentiment, which hit a more than six-year high in November, topping even the most optimistic forecast in a Reuters poll of analysts.

Rising home prices and a faster pace of sales have shown the housing market has finally turned the corner this year. The market collapsed when a mortgage debt bubble burst in 2006, helping trigger the 2007-09 recession.

The data on Monday suggested the recovery in housing is advancing even faster than many analysts had expected.

“The housing market is continuing to improve. It’s probably improving more than most economists were projecting earlier this year,” said Patrick Newport, an economist at IHS Global Insight in Lexington, Massachusetts.

The reports also support the view that the broader economic recovery is becoming increasingly self-sustaining, with job creation helping drive home sales, which in turn are supporting economic growth. Home building is expected to add to economic growth this year for the first time since 2005.

U.S. stock prices rose sharply, with investors heartened by the housing data and signs that lawmakers are making progress in talks aimed at avoiding sharp tax hikes and government spending cuts next year. Yields on U.S. government debt also rose.

The housing data also suggested that superstorm Sandy, a mammoth storm that slammed into the U.S. East Coast on October 29, continues to distort economic data in the United States.

The Northeast was the only region in the country where the pace of sales fell. NAR economist Lawrence Yun said Sandy would likely leave a bigger mark in November and December, although he expected the impact would only be temporary.

The storm, which killed more than 130 people in the United States and left millions of homes and businesses without electricity, led U.S. factories to cut production in October. It also weighed on auto sales as consumers stayed away from showrooms.

Economists, however, think Sandy’s impact on the economy will be temporary. Indeed, not all of the impact is negative. Home improvement retailer Lowes reported higher-than-expected profits on Monday as its sales got a lift from people buying items like generators, flashlights and batteries ahead of Sandy.

The housing data showed that home prices continue to rebound. In October, the median price for an existing home was $ 178,600, up 11.1 percent from a year earlier.

Supporting prices, fewer people sold their homes under distressed conditions, which include foreclosures, compared to the same period in 2011. Also, the nation’s inventory of existing homes for sale fell 1.4 percent during the month to 2.14 million, the lowest level since December 2002.

The shrinking supply of distressed and foreclosed inventory helped push U.S. homebuilder sentiment up for a seventh consecutive month in November.

The National Association of Home Builders said its sentiment index rose to 46 — the highest since May 2006 — from 41 the month before. Economists polled by Reuters had predicted the index would remain unchanged.

However, the gauge remained below 50, a reminder that the housing market was still some way off full recovery. Readings below 50 mean more builders view market conditions as poor than favorable. The index has not been above 50 since April 2006.

The measure has made strong progress over the last year, helping to cement optimism in the sector.

“Builders are reporting increasing demand for new homes as inventories of foreclosed and distressed properties begin to shrink in markets across the country,” said NAHB Chairman Barry Rutenberg.

(Additional reporting by Ed Krudy and Richard Leong in New York; Editing by Andrea Ricci and Tim Ahmann)

Business News Headlines – Yahoo! News

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