Tuesday, September 23, 2014

The price of pain: Indictments allege a massive compound cream scam

This is the third in a series on the compound cream industry. You can read Part One here andPart Two here.
Prosecutors in the Orange County District Attorney's office call it one of the largest cases they've taken on: 20,000 exhibits, 15 defendants and more than $100 million in alleged overbilling in an alleged workers' compensation fraud scheme centered around compound creams.
An Inland Empire businessman, Kareem Ahmed, is accused of masterminding the alleged scam. Prosecutors say he paid a dozen doctors, chiropractors and pharmacists a total of $25 million in kickbacks in exchange for writing, filling and billing for large numbers of compound cream prescriptions.
KPCC first reported on the indictments by the Orange County Grand Jury in June. The defendants are scheduled to be arraigned in Santa Ana on Friday.
What makes this case unusual was the volume of business, according to Assistant District Attorney Scott Zidbeck.
"We believe there were thousands of prescriptions being written and thousands being filled by multiple pharmacies in Orange County," and there were "huge markups billed to insurance companies," said Zidbeck. He said workers' compensation insurers would be billed in "the $1,500 to $3,000 range" for creams that had a wholesale cost of about $70.
Ahmed and three others formulated three creams based on the profitability of the ingredients, according to the indictments.
In California's workers' compensation system, a compound cream can be billed for every ingredient, which has been suggested as a reason why compound cream costs have skyrocketed.
Based on the high volume of prescriptions combined with the markups in price, prosecutors have calculated that participants in the case billed insurers for more than $100 million.
Compound creams are not approved by the Food and Drug Administration and are intended for limited use, typically for people who can't take oral medication. Prosecutors believe in this case compound creams were produced in bulk; federal law forbids their mass manufacture.
Zidbeck says the doctors involved in Ahmed's network were paid to participate. 
"They were given a financial incentive to write a prescription and refer that particular prescription to a certain pharmacy,"he said.

Top billers

Two of the doctors indicted for allegedly accepting kickbacks have been top compound cream billers, according to data from Los Angeles County.
In the three months spanning July-September 2012, Dr. Daniel Capen was number one in the county, the data show. Compound creams accounted for two-thirds of his prescriptions, and nearly 98 percent of the total amount of his billings.
Dr. Andrew Jarminski was the third top biller in the same time period, with creams accounting for 93 percent of his billings. 
Jarminski has declined comment. In an interview with KPCC, Capen said he thinks prosecutors went after him because of his volume of business.
"I don’t believe I committed any crime, nor did the other doctors," he said. "I think they targeted busier doctors."
Capen denied getting kickbacks in exchange for prescribing creams.
"It's not a kickback," he said. "I bought these creams, prescribe them to my patients and get remuneration, but doctors do that with injectables and other regular medicines."
Capen said he prefers compound creams because they are a less addictive option than FDA-approved narcotics.

Ahmed's attorney responds

In a written statement, Ahmed's attorney, Benjamin Gluck, said his client and the other defendants "never did anything wrong," and that he expects them to be "fully vindicated."
Gluck insisted that Ahmed's operation was completely legal. "Mr. Ahmed bought accounts receivable and billed those claims to insurance companies on letterhead showing his company’s name," wrote Gluck. "Each claim expressly set out the exact compound being used. Nothing was kept secret from anyone and every insurance company knew what it was paying for and why."
Internal emails from Ahmed's medical billing company, Landmark Medical Management, show some employees were concerned about the amounts of creams being produced.
In an email from May 2012 about another legal matter, a staff member wrote, "the problem will be that the compounds are not tailored [sic] made to every patient," and she added, "just look at our bills."
Gluck argued that there is nothing illegal about compounding drugs that are not tailor made for a patient. 
An illustration shows the alleged network of those indicted in June by the Orange County Grand Jury. (Photo courtesy of the Orange County D.A.)

FBI recordings

Among the 20,000 documents associated with the case are two FBI recordings that were made in 2010 as part of an insurance investigation involving businessman Cyrus Sorat, who eventually was convicted of mail fraud.
In October and December of 2010, Sorat wore a wire while eating lunch with Ahmed.
On the tapes, Ahmed can be heard boasting of his success: "I'm a behemoth, I make 8 to 10 million a month."
He also explained to Sorat how he marks up prices, while saying he does everything by the book. 
"It's the fee schedule man! You got to mark it up. It's like a 200 percent markup," Ahmed said. 
Ahmed also claims in the tapes that he had a hand in "shutting down" a bill in the state legislature that would have limited the reimbursements for compound creams.
"I shut it down for this year, the sleeping pile. AB 2779. Look it up, look what I did to it, what we did to it," Ahmed says.
Ahmed has donated well over $1 million to state and federal politicians and political action committees.
The recordings weren't part of the Orange County case and weren't presented to the jury that returned the indictments. Prosecutors say they’re holding on to the tapes, and will decide if they will be used as evidence at trial.
In response to the recordings, Gluck noted in his written statement that Ahmed "repeatedly told Mr. Sorat that he never pays doctors, he refused to enter a deal with a lab unless he knew it was legal."
Still, former FDA official Sarah Sellers is troubled by the nature of the conversations on the tapes.
"There is no evidence the practice of medicine is occurring," said Sellers. "There is no evidence that practice of pharmaceutical care is occurring. What is occurring is patients are being exploited as mere means for self-enrichment" said Sellers.

FDA fight with compounder tests its patience and its limits

For nearly two years, the FDA and a Texas compounder have been sparring over whether its products are safe and whether it will bend to the pressure the agency is exerting. The FDA keeps asking it to recall all of its sterile products, and NuVision Pharmacy keeps ignoring the request as it tests the limits of the FDA's authority over drug compounders. The FDA then warns healthcare providers they shouldn't use any drugs NuVision compounded, and NuVision tells customers that all is well.

The scenario is again playing out this week. The FDA sent a warning on Tuesday saying that the company cannot affirm its products are safe and that providers were taking a chance by using them. Included in the warning was a link to its letter to Dallas-based Downing Labs, which operates as NuVision, again asking the company to voluntarily recall its products and laying out a list of problems it said it discovered at the facility during an inspection that ran over 5 weeks in June and July.

The FDA said the inspection determined that 19 lots that were purportedly sterile drugs "tested positive for microbial contamination. In addition, three lots failed endotoxin testing." The FDA said that may be the result of poor aseptic filling processes and because APIs coming into the facility were contaminated with endotoxins.

But in a response on its website, NuVision said the 19 lots were never released. "We want to assure the public that the compounded lots with failed sterility and endotoxin test results were never released by our pharmacy. It is our policy to hold all compounded sterile products for a quarantine period of at least 14 days in order to wait for test results from a third party lab. Any products that fail sterility or endotoxin testing are investigated and destroyed by our pharmacy. These products are never dispensed to patients--we would be happy to provide all sterility results by our third party testing, as well as destruction logs of incineration, from our accredited third party for any lots in question."

The response goes on to outline a long list of changes it has made in response to FDA concerns. It has switched to an FDA-approved testing lab, changed gowning procedures and relocated and added HEPA filters in clean rooms. It said it is making changes that are outside the requirements of compounders to better serve its customers.

NuVision was among dozens of large-scale compounders caught up in a sweep by the FDA that began in 2012 after a fungal meningitis outbreak that killed 64 people was tracked back to a Massachusetts compounder. FDA Commissioner Margaret Hamburg was called on the carpet by Congress for not having a better fix on the situation. Because the compounding industry had fought federal oversight, the agency asked Congress for explicit authority to regulate the largest operators. Last year, Congress granted it some expanded powers: the authority to require certain standards and regularly inspect those companies which voluntarily sign up for oversight. Congress said then the market would punish bad players by giving business to those that are FDA approved.
So far, 56 sites out of more than 3,000 compounders have been registered. NuVision is not among them.


Federal jury indicts NECC pharmacist

A federal grand jury in Massachusetts on Tuesday indicted the pharmacist in charge of sterility at the New England Compounding Center.
The indictment follows last week’s arrest of Glenn A. Chin on a charge of one count of mail fraud. There were no additional charges in the indictment. Chin’s arraignment is set for 10 a.m. Thursday in U.S. District Court in Massachusetts.
The compounding pharmacy where Chin worked has been identified by the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention as the source of tainted steroids that caused the 2012 outbreak of fungal meningitis.
The indictment accuses Chin of defrauding the customers of New England Compounding Center by failing to properly maintain cleanliness, instructing personnel to fraudulently complete cleaning logs, improperly sterilizing and testing preservative-free methylprednisolone acetate, and directing personnel to label vials of the medicine as “injectable.” The vials were then shipped by interstate carriers to customers of the compounding pharmacy.
Tennessee was one of the hardest-hit states in the 2012 outbreak that sickened 751 people nationwide with 64 deaths.

Compounding Pharmacy Recalls Potentially Contaminated Drug Products

A New Jersey-based compounding pharmacy has voluntarily recalled 4 prescription preparations distributed in 4 states due to potential contamination, according to the FDA.   Pharmacy Creations first announced the recall on September 6, 2014, following test results that indicated 4 of its drug product lots “may have the potential of not being sterile,” the company warned in a press release.   “Although we cannot be certain that the product subject to the recall is contaminated, to the extent it was, there are serious health implications for the use of contaminated product in all patients which could include development of a life-threatening infection,” the company stated. “We are voluntarily recalling the products as a precautionary measure, out of an abundance of caution and in order to ensure the public health and the safety of our patients.”   According to Pharmacy Creations, the recalled lots of ascorbic acid, glutathione, magnesium chloride, and tropi/cyclo/phenyl/tobra/flurb were distributed in Florida, New Jersey, New York, and Puerto Rico between March 4, 2014, and June 18, 2014, via direct mail to patients and physicians. - 

http://www.pharmacytimes.com/product-news/Compounding-Pharmacy-Recalls-Potentially-Contaminated-Drug-Products?utm_source=GoogleNews&utm_medium=GoogleNews&utm_campaign=PharmacyTimesNews

Baxter Initiates Voluntary Recall of Potassium Chloride Injection

Baxter International announced on Sept. 16, 2014 that it is voluntarily recalling one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826, lot P318220, NDC #0338-0709-48 distributed to the hospital/pharmacy/nurse level for the treatment of potassium deficiency. The recall is being initiated due to a labeling error on the shipping cartons in a single lot, which was identified by three customers. Shipping cartons labeled for this specific lot number of Potassium Chloride Injection may contain units of Gentamicin Sulfate Injection, an antibacterial drug, 80 mg in 100 mL, product code 2B0862.
As both products are packaged in 100 mL containers, have similar code numbers, and red labeling on the front panel, there is a potential risk of medication error or delay in therapy for patients that require high-concentration potassium chloride.
The lot was distributed between May 26, 2014 and August 8, 2014. Any healthcare professionals with an existing lot are advised to carefully review the product label before administering.

Hospira Issues a Voluntary Nationwide Recall

Hospira initiated a voluntary nationwide user-level recall of one lot of Heparin Sodium, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with an expiration date of 01NOV 2015. This action is due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair, sealed between the tube and the film at the round seal of the unused Administrative Port on the non-print side of the container.
The drug being recalled is indicated as an anticoagulant to maintain catheter patency. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. The root cause has not been determined and is under investigation.
The affected lot was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals, and pharmacies. Anyone with an existing inventory should stop use and distribution and quarantine the product immediately. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle.

Sun Pharmaceutical's woes deepen as US arm Taro recalls Warfarin from markets

MUMBAI: Sun Pharma's recall worries continue with its American subsidiary Taro recalling its leading blood clot drug from the market after the USFDA found that the product did not meet its quality norms.
Taro has recalled Warfarin Sodium after the USFDA faulted its poor quality.
This is the third such recall for Sun which agreed to buy troubled fellow drug maker Ranbaxy in March this year to create the world's fifth largest generic drug maker. Sun shares slumped nearly 5 per cent early on Thursday after overnight reports of surprise inspection by the USFDA at its plant in Halol, Gujarat. It ended 4 per cent down at Rs 822.
The firm also announced plans to introduce an enabling resolution at its forthcoming shareholders meet to raiseRs 12,000 crore through a qualified institutional placement. Uday Baldota, the chief financial officer of Sun, said there are no plans to raise equity or debt and that this is just an enabling resolution as a similar permission from shareholders last year had lapsed. A QIP of the size mentioned in the resolution would be one of the largest in recent times, if it were to happen.
Baldota declined to comment on the drug recall. Warfarin is a significant drug for Taro which contributes onethird to Sun's revenue of Rs 3,927 crore and 4.5 per cent to Taro's sales of $130 million. 

Sun Pharma's recalls have increased ever since the drug maker received a warning letter from the USFDA in May this year for its Karkhadi plant in Gujarat. 
Among the many issues, the FDA found the company's staff to be hiding batch failures, conducting unofficial testing and deleting files.
In July this year, the firm had recalled 4 lakh bottles of its antidepressant drug Venlafaxine Hydrochloride for failing dissolution test. This was followed by the recall of four lakh units of its antibacterial drug Cephalexin for not following good manufacturing practices.
The recall took place under class II of the FDA recall guidelines which is defined as a situation in which the use of, or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The FDA in its letter in May wrote that there's a "general lack of reliability and accuracy of data generated by your firm's laboratory, which is a serious CGMP deficiency that raises concerns about the integrity of all data generated by your firm".
It had asked the company to address these issues and also expand its internal review to other facilities that might be involved in, or affected by, inaccurate data reporting.
The letter came one month after Sun announced the acquisition of Ranbaxy from Japanese drug makerDaiichi Sankyo for $3.2 billion. However, since the deal was announced, Sun has been battling controversies right from insider trading accusations from activist investors to answering the Competition Commission of India which has to clear the deal.
The US is the world's biggest pharma market at $24 billion and it contributes more than 50 per cent to the turnover of most Indian companies.
Indian drug makers have been battling drug recalls and quality issues for more than a year now forcing the USFDA to increase its presence and its inspections in India. This year Dr Reddy's had to recall thousands of bottles of its heartburn drug Metoprolol. Ranbaxy last year came out of a four year legal battle with the US Department of Justice which asked the company to pay $500 million fine for selling adulterated drugs in the US market.