HCA, the largest for-profit hospital chain in the US cited for unnecessary cardiac work.

HCA, the largest for-profit hospital chain in the United States with 163 facilities, had uncovered evidence as far back as 2002 and as recently as late 2010 showing that some cardiologists at several of its hospitals in Florida were unable to justify many of the procedures they were performing. Those hospitals included the Cedars Medical Center in Miami, which the company no longer owns, and the Regional Medical Center Bayonet Point. In some cases, the doctors made misleading statements in medical records that made it appear the procedures were necessary, according to internal reports.

Questions about the necessity of medical procedures — especially in the realm of cardiology — are not uncommon. None of the internal documents reviewed calculate just how many such procedures there were or how many patients might have died or been injured as a result. But the documents suggest that the problems at HCA went beyond a rogue doctor or two. 

In a recent statement, HCA declined to provide evidence that it had alerted Medicare, state Medicaid or private insurers of its findings, or reimbursed them for any of the procedures that the company later deemed unnecessary, as required by law. 

“When the company becomes aware of a situation in which we might have a reimbursement obligation, we assess, with outside resources, what our reimbursement obligations might be,” the statement said. 

HCA also declined to show that it had ever notified patients, who might have been entitled to compensation from the hospital for any harm. 

Some doctors accused in the reviews of performing unnecessary procedures are still practicing at HCA hospitals.

A 2011 study in the Journal of the American Medical Association found that only half of 144,000 nonemergency heart catheterizations — typically the use of tiny balloons and stents to clear blocked arteries — were appropriate; 38 percent were "uncertain" and 12 percent were "inappropriate." 
"It's presented in the media as if it's an aberrancy, when actually it's the rule," said Dr. David Brown, an interventional cardiologist and professor of medicine at SUNY-Stony Brook School of Medicine of the unnecessary heart procedures. "The medical system is addicted to the revenues that it generates." 
In 2011, Medicare alone spent nearly $1 billion on the procedures. While they boost revenues for doctors and hospitals, unnecessary procedures consume taxpayer money, raise insurance premiums and put patients at risk. Studies show that about 3 percent of patients experience serious complications.

http://www.nytimes.com/2012/08/07/business/hospital-chain-internal-reports-found-dubious-cardiac-work.html?pagewanted=all
http://www.propublica.org/article/to-stent-or-not-to-stent-that-is-in-question

DOJ investigating interventional cardiology services at HCA.
 
The hospital giant HCA has disclosed that the US Attorney’s Office in Miami is investigating the company and has “requested information on reviews assessing the medical necessity of interventional cardiology services provided at any Company facility (other than peer reviews).” Following its own preliminary investigation, the company said it was aware of such reviews in about 10 of its hospitals, most of which are located in Florida. The company said it did not know the full extent or nature of the investigation. (The disclosure can be found on page 16 of the company’s quarterly report.)
HCA disclosure:  
http://phx.corporate-ir.net/phoenix.zhtml?c=63489&p=irol-SECText&TEXT=aHR0cDovL2lyLmludC53ZXN0bGF3YnVzaW5lc3MuY29tL2RvY3VtZW50L3YxLzAwMDExOTMxMjUtMTItMzM2MTk2L3htbA%3d%3d
American Medical Response has paid almost $4 million to settle overbilling claims in other cities.

Manchester, NH - American Medical Response, the national ambulance company that is now the subject of a city audit, has paid out close to $4 million in recent years to settle claims it overbilled patients in two other cities. 
 
AMR is the largest private ambulance service company in the country, providing services to more than 2,100 communities, according to its website.
Independent City Auditor Kevin Buckley launched the audit last month at the direction of the Mayor and Board of Aldermen.

AMR is in the second year of a two-year contract with the city that is set to expire at the end of December. The aldermen will get to decide whether to renew the contract.

AMR concluded an internal audit that found that 323 ambulance trips out of nearly 5,000 in 2011 and 2012 had been “incorrectly billed.” In June, it forgave outstanding incorrect balances and issued $16,000 in refunds. But AMR patients have continued to complain about large bills from the company.

Buckley said he is in the data-gathering phase of his audit and is going over the database of charges provided by AMR.

In his preliminary research, Buckley discovered that AMR has been the target of legal action in Spokane, Wash., and in New York City.

Last year, AMR paid $2.7 million to settle federal charges that it defrauded Medicare and other federal health insurance programs. Prosecutors alleged that AMR “knowingly submitted falsely inflated claims” between 2001 and 2005 through its Brooklyn and Long Island offices.

In 2010, AMR agreed to pay $994,000 in a class action lawsuit brought on behalf of more than 12,000 residents of Spokane, Wash., who claimed to have been overbilled by the company.

The New York case was based on allegations that AMR engaged in “up-coding” — inaccurately classifying the nature of the service it provided, resulting in higher charges. Buckley said AMR’s internal audit didn’t look at this, but he said his review would.
http://www.unionleader.com/article/20120807/NEWS12/708079947 
Pfizer to pay $60 million over bribery allegations.
Pfizer will pay $60 million to settle federal allegations that it bribed government officials and doctors in eight foreign countries to get contracts, drug approvals and customs clearance, the SEC said.

The SEC said that bribery was "so entwined" in Pfizer subsidiaries that they had "points and bonus programs to improperly award foreign officials" who were their best customers.

Pfizer subsidiaries paid bribes in Bulgaria, China, Croatia, the Czech Republic, Italy, Kazakhstan, Russia, and Serbia, "to influence regulatory and formulary approvals, purchase decisions, prescription decisions, and to clear customs," according to the SEC complaint. "Employees in each of the involved subsidiaries attempted to conceal the true nature of the transactions by improperly recording the transactions on the books and records of the respective subsidiaries. Examples included falsely recording the payments as legitimate expenses for promotional activities, marketing, training, travel and entertainment, clinical trials, freight, conferences and advertising.
   
"These improper payments were made without the knowledge or approval of officers or employees of Pfizer, but the inaccurate books and records of Pfizer's subsidiaries were consolidated in the financial reports of Pfizer, and Pfizer failed to devise and maintain an appropriate system of internal accounting controls."

In a separate complaint, the SEC accused Wyeth - which Pfizer acquired a few years ago - of its own violations of the Foreign Corrupt Practices Act. The two companies agreed to pay more than $45 million to settle both cases, the SEC said in a statement.
Complaint: http://www.courthousenews.com/2012/08/08/SECvWyeth.pdf
   
The Justice Department said that Pfizer H.C.P. Corp. will pay another $15 million to resolve FCPA violations, according to the SEC statement.

"Pfizer subsidiaries in several countries had bribery so entwined in their sales culture that they offered points and bonus programs to improperly reward foreign officials who proved to be their best customers," an SEC official said in the statement.
http://www.courthousenews.com/2012/08/08/49097.htm

US Securities v. Pfizer: http://www.courthousenews.com/2012/08/08/SECvPfizer.pdf

Court revives suit over Cymbalta's suicide link.

Parents of a South Dakota teenager who committed suicide while taking the antidepressant Cymbalta can sue the drug's makers for failure to warn and deceit, the 8th Circuit ruled.

Dr. Richard Briggs, a family physician, allegedly gave samples of Cymbalta to 16-year-old Peter Schilf in 2004, partly because he believed this drug was less linked to suicide than other antidepressants like Prozac.

But the doctor apparently did not know that Eli Lilly & Co. had sponsored five clinical trials of Cymbalta, studying it separately from other antidepressants. There was also a Food and Drug Administration advisory that said drugmakers would have to include "black box" warnings on their antidepressants, informing consumers about the increased risk of suicidality in children and teens with major depressive disorder and other psychiatric disorders.

The Cymbalta samples given to Schilf had been removed from their packaging and contained no warning information.

Schilf's father, Paul, says he researched Cymbalta with his son, and would not have let the teen take the medication if they saw a warning about suicidality.

Schilf committed suicide one month later in December 2004, and his parents sued Eli Lilly and Quintiles Transnational Corp.

The physician who gave Schilf the Cymbalta samples testified that he did not know five suicides occurred during Cymbalta clinical trials. He also said that Eli Lilly failed to warn about a causal connection between its product and suicidality.

Eli Lilly revised the Cymbalta literature to include the FDA-approved black box warning one month after Schilf's death.
http://www.courthousenews.com/2012/08/13/49204.htm
Court Filing:
http://www.courthousenews.com/2012/08/13/Schilf.pdf