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U.S. to Force Drug Firms to Report Money Paid to Doctors

Monday, January 16th, 2012

The New York Times – January 16, 2012

by Robert Pear

The new standards carry out legislation championed by Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin. The legislation was included in the 2010 health care overhaul. “The goal is to let the sun shine in and make information available to foster accountability,” Mr. Grassley said.

WASHINGTON — To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.

Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices.

Consumer advocates and members of Congress say patients may benefit from the new standards, being issued by the government under the new health care law. Federal officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.

Large numbers of doctors receive payments from drug and device companies every year — sometimes into the hundreds of thousands or millions of dollars — in exchange for providing advice and giving lectures. Analyses by The New York Times and others have found that about a quarter of doctors take cash payments from drug or device makers and that nearly two-thirds accept routine gifts of food, including lunch for staff members and dinner for themselves.

The Times has found that doctors who take money from drug makers often practice medicine differently from those who do not and that they are more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.

Under the new standards, if a company has just one product covered by Medicare or Medicaid, it will have to disclose all its payments to doctors other than its own employees. The federal government will post the payment data on a Web site where it will be available to the public.

Manufacturers of prescription drugs and devices will have to report if they pay a doctor to help develop, assess and promote new products — or if, for example, a pharmaceutical sales agent delivers $25 worth of bagels and coffee to a doctor’s office for a meeting. Royalty payments to doctors, for inventions or discoveries, and payments to teaching hospitals for research or other activities will also have to be reported.

The Obama administration estimates that more than 1,100 drug, device and medical supply companies will have to file reports, generating “large amounts of new data.” Federal officials said they would inspect and audit drug company records to make sure the reports were accurate and complete.

Companies will be subject to a penalty up to $10,000 for each payment they fail to report. A company that knowingly fails to report payments will be subject to a penalty up to $100,000 for each violation, up to a total of $1 million a year.

Top executives are potentially liable because a senior official of each company — the chief executive, chief financial officer or chief compliance officer — must attest to the accuracy of each report.

The new requirements, or something very similar, will take effect soon; in fact, they are overdue. Under the new health care law, the administration was supposed to establish payment-reporting procedures by Oct. 1, 2011. The public will have until Feb. 17 to comment on the proposals, which are broadly consistent with the expectations of industry and consumer groups. After considering the comments, Medicare officials will issue final rules with the force of law.

Consumer advocates have long demanded details of the financial ties between doctors and drug and device companies.

Allan J. Coukell, a pharmacist and consumer advocate at the Pew Charitable Trusts, said: “Patients want to know they are getting treatment based on medical evidence, not a lunch or a financial relationship. They want to know if their doctor has a financial relationship with a pharmaceutical company, but they are often uncomfortable asking the doctor directly.”

In an introduction to the proposed rules, the Obama administration says that patients can benefit when doctors and the industry work together to develop life-saving drugs and devices. But, it said, these relationships can also “lead to conflicts of interests that may affect clinical decision-making” and “threaten the underlying integrity of the health care system.”

The administration does not try to define the difference between proper and improper payments. It says simply that public reporting of the financial ties between doctors and drug and device companies “will permit patients to make better-informed decisions when choosing health care professionals and making treatment decisions.”

The new standards carry out legislation championed by Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin. The legislation was included in the 2010 health care overhaul.

“The goal is to let the sun shine in and make information available to foster accountability,” Mr. Grassley said.

Christopher L. White, executive vice president of the Advanced Medical Technology Association, which represents makers of medical devices, said the payment data could be used by federal law enforcement agencies, plaintiffs’ lawyers and whistleblowers.

“Some companies fear that doctors may no longer want to engage in consulting arrangements, and such reluctance could chill innovation,” Mr. White said.

Medicare and Medicaid, the programs for older Americans, the disabled and the poor, spend more than $100 billion a year on drugs and devices.

Although the Congressional Budget Office does not predict immediate savings, it has said that, “over time, disclosure has the potential to reduce spending,” by reducing instances of overprescribing.

As an example of inappropriate payments, the inspector general of the Department of Health and Human Services cited a case in which manufacturers of medical devices had provided financial incentives — in the form of consulting agreements, lavish trips and other perks — to induce doctors to use particular hip and knee replacement products. Under a civil settlement with the government, the companies agreed to new compliance procedures.

The law also requires drug and device companies to report the amount of “any ownership or investment interest” held by doctors or their immediate family members, other than holdings of publicly traded stocks.

The administration intends to apply the same disclosure requirements to doctor-owned companies that distribute medical devices. Such companies allow doctors to benefit financially from sales of devices they use in surgery.

http://www.nytimes.com/2012/01/17/health/policy/us-to-tell-drug-makers-to-disclose-payments-to-doctors.html?_r=2&pagewanted=all

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Miami couple faces lengthy sentence for Medicare fraud

Wednesday, September 14th, 2011

A Miami couple who owned a South Florida chain of mental health clinics face spending the rest of their lives in prison for ripping off millions from Medicare.

Miami Herald
By Jay Weaver
September 13, 2011

From left to right: American Therapeutic Corp. senior executives Lawrence Duran, Marianella Valera, Judith Negron, Margarita Acevedo and Joseph Valdes gather at a 2009 political fundraiser in Miami for then-U.S. Senate candidate Kendrick Meek. The fundraiser was sponsored by a Washington, D.C., lobbying group, the National Association for Behavorial Health, whose members include Miami-based ATC and other mental-health clinic providers. U.S. Justice Department

Lawrence Duran was a Miami healthcare executive who regularly lobbied Congress in favor of legislation to boost government subsidies for his industry: community mental health centers. He visited with U.S. Rep. Ileana Ros-Lehtinen in Washington to drum up support. He, his girlfriend and other members of his lobbying organization threw a fundraiser for another Miami congressman, Rep. Kendrick Meek, when he ran for the U.S. Senate.

But Justice Department officials paint a far more sinister portrait of Duran and his girlfriend, Marianella Valera. They say the lobbying work was all a front to help them steal more money from the taxpayer-funded Medicare program.

Now Duran and Valera, who each pleaded guilty this year to Medicare fraud charges of running the biggest mental-health racket in the nation, face the prospect of spending the rest of their lives in prison for orchestrating the $205 million scam.

If U.S. District Judge James Lawrence King sides with prosecutors at a sentencing hearing Wednesday, Duran, 49, and Valera, 40, could be imprisoned for 50 and 40 years, respectively. Those sentences would be the longest prison terms ever for Medicare fraud offenders in the country, surpassing 30 years given to a convicted Miami doctor for her role in an $11 million HIV-therapy scheme.

Duran and Valera, who once lived together in a waterfront condo, traveled overseas and owned luxury cars, co-owned American Therapeutic Corp. Until the feds shut down the Miami-based company last October, it operated a chain of seven mental-health clinics in South Florida and Orlando that duped Medicare into paying the couple’s business $87 million during the past decade.

Their lawyers, Lawrence Metsch and Arthur Tifford, contend that they should only be held liable for that loss to the federal healthcare program — not the $205 million in fraudulent claims their company submitted to Medicare.

The loss amount, depending on how the judge rules, will be a major factor in their sentencings.

In the past year, Duran and Valera were charged along with 32 other American Therapeutic employees, psychiatrists, counselors, nurses, marketers, patient recruiters and others who supplied Medicare beneficiaries in exchange for kickbacks. American Therapeutic billed Medicare for thousands of patients, including many with dementia and Alzheimer’s disease, who had no way of benefiting from the company’s costly group-therapy sessions, prosecutors said.

Duran and several of the employees also held “charting” parties, where they would falsify the medical records of beneficiaries to make it look like they needed therapy when they actually didn’t.

About a dozen of the defendants have been convicted, including Duran and Valera’s top aides, Margarita Acevedo, who ran the marketing operation to bring in patients, and Judith Negron, who was in charge of a subsidiary, MedLink, which laundered Medicare profits to pay employees and kickbacks. Another employee, Joseph Valdes, who worked under Acevedo, also pleaded guilty.

Justice Department lawyers are seeking such an extraordinarily high sentence for Duran partly because of his role as a board member of the National Association for Behavioral Health. The Washington, D.C. coalition was established to lobby Congress on behalf of clinics that purportedly provided services to the mentally ill, prosecutors said.

The group’s brochure said it was founded in 2006 with the “express purpose of fighting what would have been devastating cuts to” community mental-health centers, such as Duran’s business, American Therapeutic.

In October 2009, Duran authored a letter to the mental health operators nationwide, expressing concern about the closure of some community clinics, Medicare’s heightened scrutiny of payments and future reimbursement rates.

“We must continue to work together to protect the benefit and our patients who so desperately need our services,” Duran wrote.

The Justice Department, however, said in court papers that the organization aided Duran’s criminal conspiracy, which resulted in Medicare millions for his business, co-owned with Valera, a licensed mental-health counselor.

Little of that money has been recovered by the FBI, Health and Human Services and Internal Revenue Service.

“In actuality, NABH was an organization that provided Duran a legitimate-looking vehicle to lobby Congress to allocate more money, through Medicare, to Duran and his co-conspirators for their fraudulent claims,” Justice Department lawyer Jennifer Saulino wrote in a recent court filing.

“He directed NABH staff to disseminate to other [community mental health centers] the tricks of his trade,” Saulino wrote, noting how he instructed others “on ways in which to win appeals of Medicare denials of claims, based on ATC’s experience.”

Duran’s company also wrote four checks to NABH totaling $49,500.

Last week, another Miami member of the lobbying organization, Biscyane Milieu Health Center, was implicated in an indictment charging its owners and about 20 others with Medicare fraud.

The organization sponsored a Miami political fundraiser for Meek in October 2009, because he was an advocate for the mentally ill and supported President Barack Obama’s healthcare reform legislation.

As part of their bid to boost Duran’s prison sentence, prosecutors filed a picture of him with Valera, Negron, Acevedo and Valdes at the Meek fundraiser.

A former Meek campaign aide told The Miami Herald that the congressman did not solicit the support of Duran’s lobbying organization. Rather, a Meek supporter knew Duran and coordinated the group’s fundraiser for the congressman, who went on to win the Democratic primary for the U.S. Senate but lost in the general election last year.

“Congressman Meek met Duran for the first time at the fundraiser,” said the former aide.

Read article here:  http://www.miamiherald.com/2011/09/13/v-fullstory/2405602/miami-couple-faces-lengthy-sentence.html

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Medicare fraud case nets dozens of arrests

Thursday, September 8th, 2011

“On Tuesday and Wednesday, federal agents fanned out across three South Florida counties, arresting a total of 42 Medicare fraud offenders. Three others charged are believed to be in Florida. The sweep came almost one year after the indictment of Miami-based American Therapeutic Corp., with seven regional clinics. A total of 24 defendants, including senior executives, psychiatrists and counselors, were charged, netting several guilty pleas and one trial conviction. That case alone accounted for $200 million in fraudulent Medicare claims during the past decade. ”

 

The Miami Herald – September 7, 2011 (Update)
by Jay Weaver

Federal agents busted 42 South Florida suspects on Medicare fraud charges as part of a Justice Department sweep targeting hotspots from Miami to Los Angeles.

The out-of-state patients, suffering from disabilities and addictions, were lured to South Florida with the promise of a roof over their head.

But once they arrived, with their valuable Medicare cards in hand, they would be squeezed into rundown assisted-living facilities and steered to purported mental-health programs — at a multimillion-dollar cost to taxpayers, authorities say. If they dropped out of the group therapy sessions, the ALF owners would toss the patients out into the street.

“They were down on their luck,” U.S. Attorney Wifredo Ferrer said, explaining how the latest Medicare scam would target patients from the Southeast. “Come on down, have a fresh start in Miami. But there was a catch.”

On Wednesday, Ferrer announced that federal agents arrested 42 suspects on Medicare fraud charges in South Florida, including the owners of Biscayne Milieu Health Center, a Fort Lauderdale psychiatrist who referred patients to the Miami Gardens clinic, patient recruiters and ALF landlords. Other defendants were operators of home healthcare agencies, HIV-therapy clinics and medical equipment businesses.

Collectively, they’re accused of submitting $160 million in false claims to Medicare for services that were either not needed or provided to patients. In turn, Medicare paid out more than $90 million, according to authorities.

The various South Florida indictments were unveiled as part of a Justice Department crackdown on Medicare fraud in hot spots such as Brooklyn, Detroit and Los Angeles, resulting in a total of 91 defendants being charged with $295 million in bogus billing.

The federal program, which caters to more than 40 million elderly and disabled patients, has been bleeding billions of dollars a year because of waste, fraud and abuse, according to healthcare experts and law enforcement.

Medicare officials recently unveiled new computer software weapons to screen prospective Medicare operators, including criminal background checks, and to scrutinize claims, which are regularly paid within 14 days. But the FBI’s special agent in charge of the Miami regional office said the massive healthcare agency needs to be far more aggressive to prevent the fraud up front.

“The FBI, Health and Human Services-Office of Inspector General and the U.S. attorney’s office devote vast resources to investigate, catch and prosecute those committing healthcare fraud,” said John Gillies, the FBI’s top South Florida agent. “But that’s addressing the problem after the fact. By then, the criminals have squandered away the money they stole.”

On Tuesday and Wednesday, federal agentsfanned out across three South Florida counties, arresting a total of 42 Medicare fraud offenders. Three others charged are believed to be in Florida.

The sweep came almost one year after the indictment of Miami-based American Therapeutic Corp., with seven regional clinics. A total of 24 defendants, including senior executives, psychiatrists and counselors, were charged, netting several guilty pleas and one trial conviction. That case alone accounted for $200 million in fraudulent Medicare claims during the past decade. The agency paid out $83 million.

This week, 10 more patient recruiters and others were charged as part of the conspiracy.

But the biggest case was the new indictment of Biscayne Milieu and 23 defendants, including the family owners, a psychiatrist, Dr. Gary Kushner, patient recruiters and ALF operators. The clinic owners are accused of paying recruiters and landlords to lure out-of-state patients into the scheme.

Among those charged: Antonio and Jorge Macli, the father and son who owned the clinic in an office park off the Palmetto Expressway. Since 2007, authorities say, Biscayne Milieu submitted $50 million in fraudulent Medicare bills, resulting in $11 million in payments.

Read the rest of the article here:  http://www.miamiherald.com/2011/09/07/2394354/dozens-arrested-in-medicare-mental.html#ixzz1XNnx5ZoS

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Two High Ranking Senators – Grassley & Kohl – Question Use of Psych Drugs in Nursing Homes

Monday, August 15th, 2011

MedPage – August 15, 2011

Emily P. Walker

Click image to watch video: Psychiatric Abuse of the Elderly

WASHINGTON — Two high-ranking senators have urged the Centers for Medicare and Medicaid Services (CMS) to take a closer look at potential over-prescribing of atypical antipsychotics to nursing home residents.

There are eight atypical antipsychotics approved by the FDA to treat schizophrenia and/or bipolar disorder, including clozapine (Clozaril), aripiprazole (Abilify), and quetiapine (Seroquel).

Atypical antipsychotics are not approved to treat dementia, and must carry black box warnings that elderly people who take atypical antipsychotics have an increased risk of death, compared with those who take placebo pills for dementia.

Still, it’s clear that these drugs are being used in nursing homes to control behavioral problems related to dementia. A 2011 report from the Department of Health and Human Services Office of the Inspector General (OIG) found that 14% of all nursing home residents with Medicare had claims for antipsychotics and 88% of the atypical antipsychotics prescribed off-label were for dementia.

And in 2009 Elli Lilly, the makers of olanzapine (Zyprexa), pled guilty and paid $1.4 billion to the federal government for allegedly targeting doctors who worked in nursing homes and assisted living facilities to prescribe olanzapine off-label to elderly patients with dementia.

In their letter, Sens. Charles Grassley (R-Iowa) and Herb Kohl (D-Wisc.), urged CMS administrator Donald Berwick, MD, to examine the issue of overuse of antipsychotics in nursing homes more closely. The letter is a follow-up to one the senators sent in May after the release of the OIG report, which the senators themselves requested.

The newest letter, sent Aug. 1, requests that CMS investigate what role pharmacy benefit managers — who manage prescription drug coverage for Medicare beneficiaries living in nursing homes — play in fueling the possible overuse of atypical antipsychotics in elderly people in long-term-care facilities.

Pharmacy benefits managers may receive rebates from drug companies for prescribing certain drugs, and CMS should look at their role in “unnecessarily increasing the use of antipsychotic drugs and to subsequently take action to address such practices and curb excess use.”

The letter also urges CMS to consider requiring that physicians, who off-label prescribe drugs with black box warnings to seniors, certify that a Part D provider will cover the drug.

If CMS followed the senators’ advice, Medicare payments for antipsychotics that “lack a medically-accepted indication” should be drastically reduced, the senators said.

“Taking such proactive steps will create disincentives for entities that administer pharmacy benefits to allow these practices to flourish while also providing CMS with clearer means to recoup erroneous payments,” Grassley and Kohl wrote.

A recent study found that the prescription cost for a typical antipsychotic increased from $38 to $41 between 2004 and 2008, while the price tag for an atypical antipsychotic rose from $226 to $323, the researcher found. Overall, the cost of typical antipsychotics in the U.S. was $600 million in 2008, while the cost of atypical drugs reached $9.9 billion.

That same study concluded that atypical antipsychotic use is growing, especially among seniors, and the drugs are increasingly prescribed off-label, sometimes without convincing evidence to support that use.

In 2008, 91% of the prescriptions written for atypical antipsychotics were for circumstances where the evidence for the efficacy was uncertain, the researchers found.

However, a separate study found that after the FDA issued a black box warning about the risks of using the drugs to soothe behavioral problems in dementia patients, there was a decline in prescribing the drugs to patients in the VA medical system.

http://www.medpagetoday.com/Geriatrics/Dementia/28052

 

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Dosed in juvie jail: Troubled doctors hired to treat kids in state custody

Monday, June 20th, 2011

By Michael LaForgia

Palm Beach Post Staff Writer

By the time Florida started paying Dr. Gold Smith Dorval to counsel and medicate jailed children, the Pembroke Pines psychiatrist already had experience with kids in state custody.

He had used them, authorities said, to bilk the government out of money for the poor.

When Dorval pleaded no contest to a felony grand theft charge, it should have barred him, by law, from working for Florida’s Department of Juvenile Justice.

It didn’t.

And, like Dorval, other doctors have emerged from past troubles and gotten jobs at DJJ – with authority to prescribe drugs to kids in state jails, a Palm Beach Post investigation has found.

Some psychiatrists took DJJ jobs after they were cited for breaking the law, making grave medical missteps or violating state rules. Others were hired after they were accused of overmedicating patients, sometimes fatally.

All were empowered to prescribe drugs to jailed kids as powerful antipsychotic pills flowed freely into Florida’s homes for wayward children.

“It’s appalling. A psychiatrist is a psychiatrist. They’re licensed, they’ve been to medical school, and there is a certain trust placed in that person’s judgment when they tell you that this child needs to be medicated,” said John Walsh, an attorney with the Palm Beach County Legal Aid Society who has represented children in juvenile court. “This just illustrates that we always have to be on guard with children.”

In two years, Florida bought hundreds of thousands of tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs for children housed in state-run jails and programs. The meds were administered in a juvenile justice system that doesn’t track prescriptions and has no way of telling whether doctors are prescribing to make kids easier to control.

In some jails and homes, pills were prescribed by psychiatrists who took huge speaker fees from companies that make antipsychotic drugs, The Post found. In others, the task fell to doctors with troubled pasts.

In response to the newspaper’s first reports, published last month, DJJ Secretary Wansley Walters launched an investigation into the department’s use of antipsychotic drugs. DJJ officials declined to discuss The Post’s latest findings, citing the probe.

Spokesman C.J. Drake acknowledged, though, that the department has struggled to find psychiatrists willing to work in jails and programs. He also said DJJ sometimes has relied on companies that employ a stable of doctors, rather than signing a contract with a single physician.

As a result, Dorval went to work in a Broward County jail for children – even though he would have failed a state-mandated background check required by the contract.

Doctor’s bogus billings

In the late 1990s, Dorval claimed he was providing juvenile delinquents and other vulnerable children with needed therapy. Instead, state investigators said, he used bogus counselors to bill Medicaid for more than $350,000 in fraudulent claims.

He charged the government for offering more than 24 hours’ worth of children’s therapy in a single day, investigators said, and structured the scheme around kids who were homeless or in DJJ custody or foster care.

He tended to bill “for those children that the system ‘lost,’ ” according to an affidavit for his arrest.

Originally charged with four felonies in Broward, Dorval pleaded no contest to one count of grand theft in 2004.

Later, to keep his medical license, he agreed to pay $10,000 and was suspended, reprimanded and put on four years’ probation.

Although a judge withheld a formal finding of guilt, the plea disqualified Dorval from seeing patients in a juvenile jail. Even so, his employer, Miami-based Compass Health Systems, sent him to work at the Broward Juvenile Detention Center between August and December 2007.

No one screened his background beforehand.

In written responses to questions, Dorval said he was doing as he was told when Compass sent him to work in the Broward juvenile jail.

“At that period you cited, the psychiatrist that was seeing patients at the DJJ was out. Therefore I was designated by the management office to go and cover for that psychiatrist, until they switched me again to another place. I was not aware of any wrongdoing,” wrote Dorval, who stressed that he never signed a contract with DJJ. “I am only an employee. Wherever they send me to work I have to go.”

As for the criminal charges, he offered this explanation: “This case was a simple matter that became complicated, because my first lawyer messed me up.” After wrangling over the facts, “they decided to offer me a plea that would allow me to get a chance to fight for my license to practice medicine,” he wrote. “It was a real nightmare that generated in me a post-traumatic syndrome that I will never forget.”

DJJ officials declined to comment on Dorval’s hiring, again citing the investigation.

Compass officials didn’t respond to questions about Dorval.

DJJ had no contract with Compass as of May, records show.

Patient’s death missed in screening

In state-operated jails and programs, the rules say DJJ must screen doctors’ backgrounds and verify that physicians’ hold valid medical licenses. In privately run programs, which house the majority of children in the department’s custody, that responsibility falls to contracted companies.

Such screenings don’t catch everything: Doctors who kept their licenses after the state accused them of serious lapses have gone on to work in juvenile jails and homes.

Dr. Charles J. Dack is an example. For six years, Dack, a Lakeland-based physician who is board-certified in addiction and child psychiatry, prescribed a cocktail of antidepressants and powerful painkillers, including methadone and morphine, to a patient named Mary Tuxbury.

Eventually, Dack ramped up the doses of pills Tuxbury was taking, keeping her “at a toxic level of morphine for approximately two and a half years,” regulators from the state health department said. In March 2002, Tuxbury was found dead. She was 42.

An autopsy showed she died of “multiple drug intoxication, namely opiates and tricyclic antidepressants.”

Regulators charged Dack with failing to meet care standards and inappropriate prescribing. Dack settled the allegations in August 2007. He admitted no wrongdoing but agreed to pay a $7,000 fine and complete a course on “misprescribing” drugs.

A year later, he was hired to care for children at three privately run programs in Central Florida: Wilson Youth Academy, Peace River Youth Academy and New Beginnings Youth Academy. He worked in the homes until April.

Dack didn’t respond to messages seeking comment.

Doctor hired after child’s death

Other DJJ doctors weren’t cited by regulators, but they were accused in court of fatal neglect. Roughly one in eight of the psychiatrists who have worked for DJJ in the past five years has settled a malpractice lawsuit in Florida, records show.

Among these was Dr. Samuel McClure. As a psychiatrist in Orlando, McClure diagnosed an 11-year-old boy named David Morganthal with attention deficit disorder. He prescribed powerful, mind-altering drugs for David – even though the child was much smaller than other kids his age, according to court documents.

One morning in November 2001, David’s mother woke to find her son dead on the floor of her double-wide mobile home. When they laid David out at the morgue, he measured less than 4-foot-2 and weighed 49 pounds.

Lab tests showed his blood contained an unusually high concentration of an antidepressant: about 60 percent more of the medication than doctors had expected.

The drug, mirtazapine, still hasn’t been approved as safe for children. David was taking the drug along with another antidepressant that hasn’t been approved for kids, citalopram.

The autopsy concluded the boy probably died from a seizure and heart problems caused by “reaction to prescription medication.”

Read the rest of the article here: http://www.palmbeachpost.com/news/state/dosed-in-juvie-jail-troubled-doctors-hired-to-1549240.html?viewAsSinglePage=true

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Feds to start directly targeting drug company execs in health care fraud schemes

Saturday, June 11th, 2011

Natural News – June 10, 2011

by Ethan A. Huff

The days of drug companies simply settling out of court every time they break the law may soon be coming to an end. In a move that represents a significant shift toward punishing individuals for crimes rather than faceless corporations, federal officials say they will begin personally going after CEOs and other company executives whose companies fraudulently bilk Medicare, Medicaid, and other federal programs out of millions of dollars, or that falsely market dangerous drugs.

When a 1996 law was passed that banned drug companies convicted of felony charges from further participating in any federal health programs, Big Pharma quickly devised creative ways to get around it. As a result, drug companies for years have been able to continually break the law without much consequence by simply settling for a few million dollars, and continuing on with shady dealings that raked in a whole lot more (http://www.naturalnews.com/001867.html).

But now, company execs could face criminal charges for crimes committed by their companies, even if they claim to have had no awareness that any crimes were being committed. And drug companies will no longer be able to skirt by after breaking the law — if they cheat the government health system, they will lose any eligibility to participate in it. After all, ignorance of the law or of the illicit dealings of one’s company have never been a legitimate excuse for anyone else to evade justice — why should it be any different for drug companies?

“When you look at the history of health care enforcement, we’ve seen a number of Fortune 500 companies that have been caught not once, not twice, but sometimes three times violating the trust of the American people, submitting false claims, paying kickbacks to doctors, marketing drugs which have not been tested for safety and efficacy,” said Lewis Morris, chief counsel for the inspector general of the Health and Human Services Department (HHS), to The  Washington Post.

“To our way of thinking, the men and women in the corporate suite aren’t getting it. If writing a check for $200 million isn’t enough to have a company change its ways, then maybe we have got to have the individuals who are responsible for this held accountable. The behavior of a company starts at the top.”

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In shift, feds target top execs for health fraud

Wednesday, June 1st, 2011

Business Week – May 31, 2011

By RICARDO ALONSO-ZALDIVAR

Federal investigators say they are starting to target individual executives in health care fraud cases previously aimed at impersonal corporations.

It’s raising the stakes for corporate honchos at drug companies, medical device manufacturers, nursing home chains and others who deal with Medicare and Medicaid.

Previously, if a company got caught, its lawyers in many cases would be able to negotiate a financial settlement. The company would write the government a big check and promise not to break the rules again.

Now, on top of fines paid by a company, senior executives can face criminal misdemeanor charges even if they weren’t involved in the scheme but could have stopped it. And they can also be banned from doing business with federal programs, a career-ending consequence.

http://www.businessweek.com/ap/financialnews/D9NI94V01.htm

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Grassley Investigates Drugging of Elderly with Antipsychotics

Wednesday, June 1st, 2011

DesMoines Register
May 31, 2011

Sen. Charles Grassley recently sent a letter to the administrator of the U.S. Centers for Medicare and Medicaid Services. He wants some answers after a federal report Grassley requested found many nursing home residents with dementia are given antipsychotic drugs. These drugs are not approved to treat dementia. They can be lethal for those afflicted with it, and Medicare has been paying for them.

Grassley is right to ask questions of the agency. But keeping seniors safe is a responsibility that extends far beyond CMS — from the halls of Congress to state legislatures to nursing home workers in rural Iowa.

Washington

Politicians talk out of both sides of their mouths. They say they want to cut federal spending. They say there should be less government regulation. Then when something goes wrong, they demand federal agencies solve the problems or they take them to task for not doing what they were supposed to do.

Drug safety, nursing home oversight, and ferreting out problems in government programs like Medicare requires staff and resources. That takes money – some of the same money lawmakers propose cutting from the federal budget.

State legislatures

The “cut government but still expect it to keep everyone safe” attitude is prevalent at the state level, too. Shortly after Gov. Terry Branstad took office, one of his appointees cut positions for nursing home inspectors. It underscored a lack of understanding about the important and complicated work of making sure homes meet more than 150 regulatory standards.

In addition to observing care, talking to staff, interviewing residents and other tasks, an inspection team reviews medical records. It is frequently a registered nurse employed by the state who finds problems with medications. Having too few state inspectors puts seniors at risk.

Nursing homes and staff

Improving the quality of life for patients with dementia is difficult — and there are too few drugs approved specifically to do so. Even if doctors are aware of the risks, they may prescribe specific drugs to make patients more comfortable or less agitated. Also, drug companies benefit when more people take their drugs, and they want doctors to prescribe their drugs to, well, as many people as possible. In fact, several drug companies have faced criminal charges for promoting antipsychotic drugs for unapproved uses.

It’s up to nursing home staff and physicians to ensure that drugs prescribed are safe for specific patients.

* * *

Every day about 10,000 Americans become eligible for Medicare. An aging population means more people will be diagnosed with dementia. More will need care in facilities. Everyone — from doctors prescribing drugs to the government paying for them — must do more to keep older people safe.

Read article here:  http://www.desmoinesregister.com/article/20110601/OPINION03/106010328/-1/GETPUBLISHED03wp-rss2.php/More-need-help-protect-our-elderly

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Cause for alarm: Antipsychotic drugs for nursing home patients

Tuesday, May 31st, 2011

CNN
By Daniel R. Levinson, Special to CNN
May 31, 2011

Daniel Levinson, inspector general for the OIG in the Department of Health and Human Services.

When a loved one moves into a nursing home, the support of family and friends is particularly important. This is especially true when the nursing home patient has dementia and can’t adequately advocate on his or her own behalf.

A newly released report from my office — the Office of the Inspector General for the Department of Health and Human Services — makes clear just how crucial it is for families to monitor and ask questions about medications that such patients receive. The report found that too often, elderly residents are prescribed antipsychotic drugs in ways that violate government standards for unnecessary drug use.

Frequently, they are prescribed in ways that don’t qualify as medically accepted for Medicare coverage. In addition, the drugs were predominately prescribed for uses that are not approved by the Food and Drug Administration.

But the most potentially troubling finding of the study is this: Researchers found that 88% of the time, these drugs were prescribed for elderly people with dementia.

This is precisely the population that faces an increased risk of death when using this class of drugs, according to the FDA. That’s why the agency puts its strongest safety warning, called a “black box warning” on these antipsychotic drugs, cautioning about the risk of death when taken by elderly people with dementia.

The report didn’t investigate why patients with dementia are prescribed antipsychotic drugs so often. But a series of lawsuits and settlements that my office helped bring about suggests that many pharmaceutical companies have improperly promoted these drugs to doctors and nursing homes for many years.

Another view: In defense of antipsychotics for dementia

The study began a few years ago, when a member of Congress questioned how many nursing home residents received a class of antipsychotic drugs introduced in the 1990s, among them risperidone and olanzapine. These drugs are known as “atypical” or “second generation” antipsychotics. They replaced the antipsychotic drugs introduced in the 1950s and 1960s to treat schizophrenia — and, incidentially, are far costlier.

The report found about 305,000 nursing home residents (about 14%) had Medicare claims for atypical antipsychotic drugs. Of these, about one in five residents was prescribed these antipsychotics in a way that violated government standards for their use. For example, residents were on a drug for too long, or at too high a dose.

Another finding: A little more than half the antipsychotic drug claims for which Medicare paid should not have been covered. Why? The claimed drugs were not used for medically accepted reasons or there were no records the drugs were actually provided.

To be clear: Most physicians and nursing homes dispense antipsychotic drugs with the best interests of patients in mind. Physicians can use their medical judgment to prescribe drugs for uses unapproved by the FDA, and also to patients for whom the boxed warning applies. Ideally, however, doctors who prescribe in such ways first determine that the benefits outweigh the risks.

Yet it remains a concern that so many elderly nursing home residents with dementia are prescribed antipsychotics. And, unfortunately, examples abound of companies’ improper promotion of these drugs.

Government investigations of Bristol-Myers Squibb, AstraZeneca and Pfizer found that they improperly promoted their antipsychotic drugs for unapproved uses.

Federal prosecution is pending against Johnson & Johnson for allegedly paying millions of dollars in kickbacks to induce Omnicare, the nation’s largest long-term care pharmacy, to recommend the use of Risperdal in treating nursing home patients, many of whom had dementia.

And Eli Lilly pleaded guilty to criminal charges associated with illegally marketing its drug Zyprexa, including to doctors who treat elderly nursing home patients.

Pharmaceutical companies have paid billions to resolve civil and criminal liabilities under federal health and safety laws. But money can’t adequately compensate for corporate campaigns that could put vulnerable, elderly patients at risk.

How do we solve this problem? There’s plenty to do.

Family members of nursing home residents must learn about their loved ones’ medications, the reasons for their use, proper dosages and possible side effects.

Nursing homes and pharmacies that serve the elderly must keep the best interests of the patient in mind when dispensing pharmaceuticals and not base the decision on the improper influence of drug companies.

Doctors, too, should rely on their best medical judgments and engage in an especially careful analysis when prescribing drugs for off-label use.

Government must combat illegal off-label promotion of these powerful and potentially lethal drugs and uphold nursing home safety standards.

And drug companies should follow the laws, and refrain from promoting drugs for unapproved uses — or paying kickbacks to influence doctors and institutions. About 46 million people are enrolled in Medicare. That will only grow as the huge baby boomer population retires. We cannot afford to leave unaddressed the urgent problem of antipsychotic drug use among elderly nursing home residents.

The opinions in this commentary are solely those of Daniel Levinson.

Read article here:  http://www.cnn.com/2011/OPINION/05/31/levinson.nursing.home.drugs/

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In shift, feds target top execs for health fraud

Tuesday, May 31st, 2011

Associated Press
May 31, 2011

Lewis Morris, general counsel for the Department of Health and Human Services inspector general, poses for a portrait in his office in Washington, Thursday, May 26, 2011. (AP Photo/Jacquelyn Martin)

WASHINGTON (AP) — It’s getting personal now. In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.

The new tactic is raising the anxiety level — and risks — for corporate honchos at drug companies, medical device manufacturers, nursing home chains and other major health care enterprises that deal with Medicare and Medicaid.

Previously, if a company got caught, its lawyers in many cases would be able to negotiate a financial settlement. The company would write the government a check for a number followed by lots of zeroes and promise not to break the rules again. Often the cost would just get passed on to customers.

Now, on top of fines paid by a company, senior executives can face criminal charges even if they weren’t involved in the scheme but could have stopped it had they known. Furthermore, they can also be banned from doing business with government health programs, a career-ending consequence.

Many in industry see the more aggressive strategy as government overkill, meting out radical punishment to individuals whose guilt prosecutors would be hard pressed to prove to a jury.

The feds say they got frustrated with repeat violations and decided to start using enforcement tools that were already on the books but had been allowed to languish. By some estimates, health care fraud costs taxpayers $60 billion a year, galling when Medicare faces insolvency.

“When you look at the history of health care enforcement, we’ve seen a number of Fortune 500 companies that have been caught not once, not twice, but sometimes three times violating the trust of the American people, submitting false claims, paying kickbacks to doctors, marketing drugs which have not been tested for safety and efficacy,” said Lewis Morris, chief counsel for the inspector general of the Health and Human Services Department.

“To our way of thinking, the men and women in the corporate suite aren’t getting it,” Morris continued. “If writing a check for $200 million isn’t enough to have a company change its ways, then maybe we have got to have the individuals who are responsible for this held accountable. The behavior of a company starts at the top.”

Lawyers who represent drug companies say the change has definitely caused a stir, but the end result is far from certain.

“People are alarmed,” said Brien O’Connor, a partner in the Boston office of Ropes & Gray. “They want to know what facts and circumstances would cause the Justice Department to indict someone who hadn’t even known about the misconduct. They are doing all they can to achieve compliance.”

Others say high-powered corporate targets won’t go meekly.

“If the government does continue to press its campaign against individuals, we will see the limits of the government’s theories tested,” said Paul Kalb, who heads the health care group at the law firm of Sidley Austin in Washington. “In my mind, there is a very important open question as to whether individuals can be held criminally culpable or lose their jobs simply by virtue of their status.”

Although the Obama administration has increased scrutiny of corporate America generally, this shift in health care enforcement seems to have come up from the ranks, government and corporate attorneys say.

Investigators and lawyers at the HHS inspector general’s office, the Justice Department and the Food and Drug Administration started moving more or less independently toward holding executives accountable. Morris outlined the inspector general’s position in congressional testimony this spring, saying his office will use its power judiciously.

A test case is playing out with an 83-year-old drug company chief executive, Howard Solomon of New York City-based Forest Laboratories. Forest makes antidepressants, blood pressure drugs and other medications. Last month, the inspector general’s office notified Forest that Solomon could potentially be banned from doing business with federal programs.

The power to ban or “exclude” an individual rests with the inspector general. It’s routinely applied to low-level violators, but rarely to people of Solomon’s rank. In the industry, they call it the “death penalty.”

Last year, a Forest subsidiary pleaded guilty to criminal charges as part of a settlement with the Justice Department in which the company also agreed to pay $313 million to resolve long-running investigations. Prosecutors charged that Forest deliberately ignored an FDA warning to stop distributing an unapproved thyroid drug, promoted the use of an antidepressant in treating children although it was only approved for adults and misled FDA inspectors making a quality check at a manufacturing plant.

The company said it had considered the case closed. But then came the inspector general’s letter.

“No one has ever alleged that Mr. Solomon has done anything wrong and excluding him would be completely unjustified,” Herschel Weinstein, Forest’s general counsel, said in a statement. “In prior cases where a senior executive has been excluded, that individual has been accused of wrongdoing and ultimately has either been convicted of or (pleaded) guilty to a crime.”

Forest is fighting the move to ban Solomon. The inspector general’s office refused to comment on the case, and no final decision has been made. In congressional testimony, Morris said that when there is evidence an executive knew or should have known about misconduct, the inspector general “will operate with a presumption in favor of exclusion of that executive.”

Separate from the inspector general’s power to ban, the FDA has resurrected something called the “Park Doctrine,” which makes it easier for prosecutors to bring criminal charges against an executive.

The doctrine, stemming from a 1970s Supreme Court case, allows the government to charge corporate officers in the chain of command with a criminal misdemeanor. They could face up to a year in prison and fines if they had the authority and responsibility to prevent, detect or resolve misconduct affecting the public welfare but failed to do so.

It’s making an entire industry nervous.

Read article here:  http://www.google.com/hostednews/ap/article/ALeqM5jIGsUXYEAKspVXkeAdCDNumbbNFA?docId=d620a807289f47a6b01dfe728972a0b3

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