Monday, July 28, 2014

Texas medical board charges controversial Houston cancer doctor: Clinic promotes unapproved drugs while knowing most patients were ineligible for the experimental therapy; Note that the Doctor owns the pharmacy and the lab also

Texas medical board charges controversial cancer doctor


Invoking Anti-Fraud Law, Louisiana Doctor Gets Rich--A Whistleblower in Health Care Fraud

FDA Import Alerts Modified in the Last Seven Days Several Relating to Unapproved Drugs and API

 
Import Alert
 
Desc Text
 
URL
IA-12-10
Detention Without Physical Examination of Cheese Due to Microbiological Contamination
IA-16-120
Detention Without Physical Examination of Fish/Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP
IA-16-124
Detention Without Physical Examination Of Aquaculture Seafood Products Due To Unapproved Drugs
 
 
IA-16-125
DETENTION WITHOUT PHYSICAL EXAMINATION OF REFRIGERATED (NOT FROZEN) RAW FISH AND FISHERY PRODUCTS THAT ARE VACUUM PACKAGED OR MODIFIED ATMOSPHERE PACKAGED OR PACKAGED IN A MATERIAL THAT IS NOT OXYGEN- PERMEABLE DUE TO THE POTENTIAL FOR CLOSTRIDIUM BOTULINUM TOXIN PRODUCTION
 
 
IA-16-39
Detention Without Physical Examination of Processed Seafood and Analogue Seafood (Surimi) Products for Listeria Monocytogenes
 
IA-16-74
Detention without physical Examination of *** Uneviscerated Fish Or Partially Eviscerated Fish that are either Sat-Cured, Dried, Smoked
Acidified, Pickled, Fermented or Brined
 
IA-16-81
Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella
IA-21-04
DETENTION WITHOUT PHYSICAL EXAMINATION OF DRIED, PRESERVED FRUITS FROM INDICATED COUNTRIES/AREAS
IA-21-05
Detention Without Physical Examination of Dates from China Due to Filth
IA-45-02
Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors
 
IA-55-03
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIFFERENT FORMS OF HEPARIN AND HEPARIN-RELATED PRODUCTS FOR CGMP ISSUES
 
IA-55-05
DWPE of Finished Dosage Drug Products - API's and Inactive Ingredients for Potentially Hazardous Micro Contamination
IA-60-01
Tagamet Tablets Cimetidine Tablets (Canada)
IA-66-40
Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs
IA-66-41
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
IA-76-01
Detention Without Physical Examination Of Medical Instruments from Pakistan 2
IA-80-04
Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves
 
IA-95-04
Detention Without Physical Examination Of Laser Pointers, Laser Gunsights, Laser Levels, Laser Light Shows, Laser Pointer Key Chains, & Similar Products That Fail To Comply With Applicable Performance Standards And Reporting Requirements
 
IA-99-05
Detention Without Physical Examination Of Raw Agricultural Products for Pesticides
IA-99-08
Detention Without Physical Examination Of Processed Foods for Pesticides
IA-99-19
Detention Without Physical Examination Of Food Products Due To The Presence Of Salmonella
IA-99-20
Detention Without Physical Examination Of Imported Food Products Due to NLEA Violations
 
IA-99-32
DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS FROM FIRMS REFUSING FDA FOREIGN ESTABLISHMENT INSPECTION
 
 
IA-99-38
DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS OR ACIDIFIED FOODS DUE TO INADEQUATE PROCESS CONTROL
 
24
 
 

Resources for You FDA Provides Equine Veterinarians with Important Information about TILDREN and OSPHOS for Navicular Syndrome in Horses

Resources for You FDA Provides Equine Veterinarians with Important Information about TILDREN and OSPHOS for Navicular Syndrome in Horses

Sunday, July 27, 2014

2014 TPA Conference & Expo CE Handouts - Texas Pharmacy Association

2014 TPA Conference & Expo CE Handouts - Texas Pharmacy Association

How gaps in regulation of compounding pharmacy set the stage for a multistate fungal meningitis outbreak Journal of American Pharmacists Association (2014)

How gaps in regulation of compounding pharmacy set the stage for a multistate fungal meningitis outbreak
Besu F. Teshome; Kelly R. Reveles; Grace C. Lee; Laurajo Ryan; Christopher R. Frei
J Am Pharm Assoc (2003) 2014;54:441-445. doi:10.1331/JAPhA.2014.14011

In one fast-growing area of fraud, involving pharmacies and prescription drugs, federal investigators have seen caseloads quadruple over the past five years: Health Care Fraud The $272 billion swindle

read story from the Economist here

Medicare Fraud Strike Force charges 90 individuals for approximately $260 million in false billing

Medicare Fraud Strike Force charges 90 individuals for approximately $260 million in false billing

Pharmacy Scam Growing Trend in Health Care Fraud

Pharmacy Scam Growing Trend in Health Care Fraud
Written by Patrick Quillian

According to the FBI, health care fraud in the United States costs an estimated $80 billion annually. A Cornell University School of Law overview of health care fraud explains that 10 cents of every dollar spent on health care goes toward paying fraudulent health care claims.
The federal government does not like people dipping into its pocketbook, and thus, it aggressively prosecutes Medicare fraud and Medicaid fraud. A Health Care Fraud and Abuse Control Program (HCFAC) report says that under the program, “Convictions . . . increased by over 27 percent (from 583 to 743) between 2009 and 2011, and the number of defendants facing criminal charges filed by federal prosecutors in 2011 increased by 74 percent (from 821 to 1430) compared with 2008.” The feds are clearly cracking down on health care fraud and abuses of the Medicare system.
Although patients may be involved in health care fraud, the majority of schemes are perpetrated by health care providers. Typically, they bill Medicare or insurance providers for services not rendered, more expensive equipment than provided, and similar types of fraudulent and inflated billing. Sometimes, a health care provider will work in conjunction with a patient to perpetrate a fraud. This is what is happening more frequently in a pharmacy scam that CNBC says is bilking millions of dollars from taxpayers.
Tom O'Donnell, special agent in charge with the Health and Human Services Office of Inspector General (HHS-OIG), says that unscrupulous pharmacy owners

more here
 

Saturday, July 26, 2014

Update on U.S Vladimir Kleyman, who is compounding pharmacist charged with paying referrals/kickbacks to doctor to refer prescriptions for a compounded pain to Prescriptions R US. The pain creame contained several components, including ketamine (a Schedule III non-narcotic), lidocaine, and diclofenac

06/12/201416 ORDER TO CONTINUE - Ends of Justice as to VLADIMIR KLEYMAN Time excluded from 7/25/2014 until 8/25/2014.. Signed by Magistrate Judge James B. Clark on 6/12/2014. (mw, ) (Entered: 06/13/2014)

Pharmacist Charged with Paying More Than $50,000 in Kickbacks to Doctor for Prescription Referrals

U.S. Attorney’s Office January 09, 2014
  • District of New Jersey (973) 645-2888
NEWARK—A pharmacist with a compounding pharmacy in Lakewood, New Jersey was arrested today and charged with paying more than $50,000 to a Toms River, New Jersey physician to induce the doctor to make prescription referrals to the pharmacy, U.S. Attorney Paul J. Fishman announced.
Vladimir Kleyman, 42, of Lakewood, New Jersey, the president and pharmacist in charge of Prescriptions R US—a compounding pharmacy in Lakewood—was charged with violating the Anti-Kickback Statute by using a middle-man to provide repeated cash payments—totaling at least tens of thousands of dollars—to a New Jersey physician over the course of several months. Kleyman appeared before U.S. Magistrate Judge James Clark, III in Newark federal court this afternoon.
According to the complaint unsealed today:
Beginning in February 2013, Kleyman provided one of his employees with at least $50,000 in cash or checks to provide bribes to the physician to refer prescriptions for a compounded pain cream to Prescriptions R US. Pharmacy compounding describes the preparation of medication, using different types and dosages of drugs, in order to provide more personalized medications for patients. The compounded pain cream prepared by Prescriptions R US in this case contains several components, including ketamine (a Schedule III non-narcotic), lidocaine, and diclofenac.
A computer-generated document prepared by Kleyman or someone working with him, and purporting to reflect the names of 63 patients for whom prescriptions for the pain cream had been sent by the bribed physician referenced in the complaint, included at least 33 Medicare beneficiaries for whom Prescriptions R US had received reimbursement from Medicare for prescriptions referrals from the bribed physician. In 2013, Prescriptions R US obtained more than $40,000 from Medicare alone in connection with filling prescriptions for the bribed physician referenced in the complaint—separate and apart from additional money Prescriptions R US obtained from other health care insurance providers.
In a series of meetings in November and December 2013, the unidentified employee received more than $50,000 in cash or checks from Kleyman or Kleyman’s spouse—who also works at Prescriptions R US—with the understanding that the bulk of that money would be used to bribe the physician to make prescription referrals to Prescriptions R US.
U.S. Attorney Fishman credited special agents of the FBI, under the direction of Special Agent in Charge Aaron T. Ford; U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge Thomas O’Donnell; and IRS–Criminal Investigation, under the direction of Special Agent in Charge Shantelle P. Kitchen, with the ongoing investigation leading to today’s charges.
The government is represented by Assistant U.S. Attorney Jane Yoon and Senior Litigation Counsel Andrew Leven of the U.S. Attorney’s Office Health Care and Government Fraud Unit in Newark.
U.S. Attorney Paul J. Fishman reorganized the health care fraud practice at the New Jersey U.S. Attorney’s Office shortly after taking office, including creating a stand-alone Health Care and Government Fraud Unit to handle both criminal and civil investigations and prosecutions of health care fraud offenses. Since 2010, the office has recovered more than $520 million in health care fraud and government fraud settlements, judgments, fines, restitution, and forfeiture under the False Claims Act; the Food, Drug, and Cosmetic Act; and other statutes.
The charges and allegations contained in the complaint are merely accusations, and the defendant is presumed innocent unless and until proven guilty.
This content has been reproduced from its original source.