Monday, September 30, 2019

Former Virginia pharmacy owner gets 4-year sentence for prescription fraud Maia Anderson - 6 hours ago Print | Email

It was the biggest scam in Tricare's history. Now troops may be going to jail Patricia Kime, September 30, 2019 at 02:18 PM

Former CT Physician Pays $300K To Settle False Claims Act Allegations Zak Failla 10/01/2019 5:00 a.m.
4 days ago - T: (614) 466.4143 | F: (614) 752.4836 | | Notice on the Enforcement of USP Compounding Chapters for.
7 hours ago - In a stomach-turning report on the 7500 compounding pharmacies operating in the United States, John Oliver revealed some truly harrowing statistics that left ...
15 hours ago - That policy relied on "enforcement discretion" to allow bulk compounding of vasopressin, the active ingredient in Vasostrict(R) , which is manufactured by Endo's ..
8 hours ago - The company had initially sued the FDA in October 2017, challenging its interim policy authorizing the bulk compounding of drugs, including Endo's antidiuretic 
11 hours ago - 'Wild west of the drug industry': John Oliver takes on compounding pharmacies. The Last Week Tonight host looks into the largely unregulated, and therefore ...
18 hours ago - Compounding pharmacies have messed with the wrong celebrities. On Sunday's episode of Last Week Tonight, John Oliver and a star-studded guest list hit ...
11 hours ago - Before the cameos, Oliver defined the compounding process and dove into the hazards that have made headlines. Compounding pharmacies, he explained, ...
12 hours ago - Uploaded by LastWeekTonight
Compounding pharmacies do the important work of tailoring medications to the needs of a particular patient ...
14 hours ago - John Oliver assembled a team of celebrities, including Jimmy Kimmel and Kristen Bell, to take on “the Wild West of the drug industry,” as he called compounding ...
18 hours ago - America's roughly 7,500 compounding pharmacies "exist for a very good reason," he explained: To make "bespoke medications" for people (and animals) with ...

20 hours ago - Celebrities joined Last Week Tonight With John Oliver to create a PSA against corrupt compounding pharmacies. Unlike traditional drug manufacturers and ...

Thursday, September 26, 2019

3 days ago - Those standards include general chapters <795> (Pharmaceutical Compounding – Nonsterile Preparations), <797> (Pharmaceutical Compounding – Steril
FDA Cautions Pet Owners Not to Feed Performance Dog Raw Pet Food Due to Salmonella, Listeria monocytogenes
  • The U.S. Food and Drug Administration (FDA) is cautioning pet owners not to feed their pets any Performance Dog frozen raw pet food after a sample tested positive for Salmonella and Listeria monocytogenes (L. mono).
  • Two samples of different finished products collected during an inspection of Bravo Packing, Inc., the manufacturer of Performance Dog raw pet food, tested positive for Salmonella and/or L. mono. One of the products sampled had not yet been distributed.
  • The product that entered the marketplace is Performance Dog raw pet food, lot code 072219, sold to customers frozen in two-pound pouches.  However, the FDA is cautioning about all Performance Dog frozen raw pet food produced on or after July 22, 2019 because the products do not have lot codes printed on retail packaging. If you have any Performance Dog product that you purchased after July 22, 2019, throw it away.
  • FDA is issuing this alert because Performance Dog raw pet food represents a serious threat to human and animal health. Because these products are sold and stored frozen, FDA is concerned that people may still have them in their possession.
  • Salmonella and L. mono can affect both human and animal health. People with symptoms of Salmonella or L. mono infection should consult their health care providers. Consult a veterinarian if your pet has symptoms of Salmonella or L. mono infection.
FDA Issues Draft Guidance on Expanded Conditional Approval for Certain Animal Drugs
The U.S. Food and Drug Administration today released draft Guidance for Industry, entitled “Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs,” to assist animal drug sponsors and potential sponsors who may be interested in pursuing conditional approval to market animal drugs  to address serious or life-threatening diseases or conditions, or an unmet animal or human health need, and for which demonstrating effectiveness would require complex or particularly difficult study or studies.

Until recently, only new animal drugs intended for minor use in major species or for use in a minor species (MUMS) were eligible for conditional approval.  In 2018, as part of the reauthorization of FDA’s Animal Drug User Fee Act (ADUFA) program, Congress amended section 571 of the Federal Food, Drug and Cosmetic Act (FD&C Act) to expand FDA’s authority to grant conditional approval to include certain animal drugs for use in major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens) for diseases or conditions that would not be eligible for conditional approval under the MUMS provisions of the FD&C Act.  

Expanded conditional approval has the potential to incentivize drug development and provide veterinarians with legally marketed new animal drugs to treat serious or life-threatening diseases or conditions and to fill treatment gaps where currently no therapies are available.

Measles Patient Who Traveled Through LAX in September Might Have Exposed Others to Disease, Officials Warn POSTED 1:31 PM, SEPTEMBER 25, 2019, BY KRISTINA BRAVO, UPDATED AT 05:53PM, SEPTEMBER 25, 2019

Wednesday, September 25, 2019

Remarks from Acting FDA Commissioner Ned Sharpless, M.D. as prepared for testimony before a U.S. House Energy and Commerce Subcommittee on FDA Regulation of Electronic Nicotine Delivery Systems and Investigation of Vaping Illnesses

Good morning, Chairwoman DeGette, Ranking Member Guthrie, and Members of the subcommittee. 

Thank you for the opportunity to be here today to discuss the regulation of electronic nicotine delivery systems, or ENDS, and the Agency’s role in the ongoing investigation into lung injuries experienced by individuals who use vaping products. 

As you know, prior to coming to FDA, I was Director of the NCI, and I’m a long-time cancer doctor. My experience treating patients has informed all of my work at the agency including the issues before the committee today.  

We are here to discuss two top priority issues: first, the ongoing investigation into the cause of lung injury associated with the use of vaping products. Second, FDA’s ongoing efforts to ...

Tuesday, September 24, 2019

Charges Brought Against 34 Individuals for Alleged West Coast Medicare and Medicaid Fraud Schemes Totaling $258 Million

Department of Justice
Office of Public Affairs

Wednesday, September 18, 2019

Charges Brought Against 34 Individuals for Alleged West Coast Medicare and Medicaid Fraud Schemes Totaling $258 Million

Assistant Attorney General Brian A. Benczkowski of the Justice Department’s Criminal Division announced today a health care fraud enforcement action in the state of California, involving charges brought against a total of 26 individuals in the Central District of California for their alleged involvement in Medicare and Medicaid fraud schemes resulting in $257 million in billings.  Of those charged, 14 were doctors or medical professionals.    In addition, in the states of Arizona and Oregon, eight defendants, including three licensed medical professionals, have been charged with defrauding the Medicaid program out of over $1 million.  These cases were investigated by each state’s respective Medicaid Fraud Control Units
Today’s enforcement action was led and coordinated by the Health Care Fraud Unit of the Criminal Division’s Fraud Section in conjunction with its Medicare Fraud Strike Force (MFSF) partners, a partnership between the Criminal Division, U.S. Attorney’s Offices, the FBI and the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG).  In addition, the operation includes the participation of various other federal law enforcement agencies and the California Department of Justice, including the U.S. Department of Labor, Office of Inspector General, the U.S. Department of Labor, Employee Benefits Security Administration, the U.S. Department of Defense, Defense Criminal Investigative Service, the Amtrak Office of Inspector General, the U.S. Office of Personnel Management, Office of Inspector General and the California Department of Insurance.
The charges announced today aggressively target schemes billing Medicare and Medicaid for services, testing and prescriptions that were not medically necessary or not actually provided to beneficiaries. 
“Today’s action shows that our ability to detect and prosecute health care fraud grows more sophisticated with each passing day,” said Assistant Attorney General Brian A. Benczkowski of the Justice Department’s Criminal Division.  “The Department of Justice is using every tool at our disposal to target the medical professionals and others who place their personal greed above the public good.”
“Corruption drains dollars from private insurers and public programs such as Medicare and Medicaid,” said U.S. Attorney Nick Hanna of the Central District of California.  “This office will continue to hold accountable anyone – including medical professionals – who seek to bilk our nation’s health care system.”
“Sticking taxpayers with a bill for unnecessary healthcare services will never be tolerated,” said Special Agent in Charge Timothy B. DeFrancesca of the U.S. Health and Human Services, Office of the Inspector General.  “Working closely with our law enforcement partners, our agency will tirelessly pursue physicians and others who threaten the integrity of Federal healthcare programs.” 
“Health care fraud schemes cheat American taxpayers and health care programs out of millions of dollars,” said Assistant Director in Charge Paul D. Delacourt of the FBI’s Los Angeles Field Office.  “With the assistance of the public, the FBI and partner agencies will continue to combat this unscrupulous criminal activity that seeks to financially exploit our healthcare system.”
“Criminal activity that drives up medical costs for Californians at the expense of vulnerable communities will not be tolerated,” said California Attorney General Xavier Becerra.  “The California Department of Justice will continue to seek opportunities to work with our federal partners to not only prevent wrongdoing, but also target fraudsters and hold them accountable.”
“Health plans are tempting targets for unscrupulous individuals,” said Los Angeles Regional Director for the U.S. Department of Labor’s Employee Benefits Security Administration Crisanta Johnson.  When wrongdoers victimize health plans and their participants, EBSA and its fellow enforcement agencies will take prompt, aggressive, and coordinated action to hold them accountable.”  
Among those charged in Strike Force cases in the Central District of California are the following:
Ronald Weaver, M.D., 70, of Pacific Palisades, California, Sara Soulati, 49, of Santa Monica, California, John Weaver, M.D., 75, of Alhambra, California, Ronald Carlish, M.D., 78, of Pacific Palisades, California, Howard Elkin, M.D., 68, of Whittier, California, Wolfgang Scheele, M.D., 79, of Los Angeles, California, and Nagesh Shetty, M.D., 74 of Huntington Beach, California, were charged for their alleged participation in an approximately $135 million scheme to defraud Medicare through medically unnecessary cardiac treatments and testing through Global Cardio Care of Inglewood, California.  The case is being prosecuted by Trial Attorneys Emily Z. Culbertson and Alexandra Michael of the Criminal Division’s Fraud Section.
Hilda Haroutunian, 59, of Sun Valley, California, Keyvan Amirikhorheh, M.D., 60, of Seal Beach, California, Lorraine Watson, 56, a physician’s assistant, of Valley Village, California, Noem Sarkisyan, 63, of North Hollywood, California, and Edmond Sarkisyan, 40, a medical assistant, of North Hollywood, California, were charged for their alleged participation in an approximately $10 million scheme to defraud the Family Planning, Access, Care and Treatment (Family PACT) program administered by Medi-Cal, the California Medicaid program, through fraudulent claims for family planning services, testing and prescriptions for non-existent patients submitted through Los Angeles Community Clinic, in Los Angeles, California, and associated diagnostic testing laboratories and pharmacies.  The case is being prosecuted by Trial Attorney Alexis D. Gregorian of the Fraud Section.
Antonio Olivera, 78, of Downey, California, Emelita Cephass, 57, of Downey, California, and Martin Canter, 70, of Rancho Palos Verdes, California, were charged for their alleged participation in a hospice kickback scheme.  Olivera was also charged for his alleged participation in a scheme to defraud Medicare, all involving Mhiramarc Management LLC, a hospice located in Downey, California.  In a separate case, John O’Brien, hospice owner, was charged with health care fraud conspiracy for his alleged role in the fraud scheme.  The cases are being handled by Trial Attorney Justin P. Givens of the Fraud Section.
Among those charged in cases being handled by the U.S. Attorney’s Office for the Central District of California are the following:
Navid Vahedi, 40, of Los Angeles, California, Vahedi’s pharmacy “Fusion Rx Compounding Pharmacy,” and Joseph S. Kieffer, 39, of Los Angeles, California, were charged for the alleged participation in a fraud and illegal kickback scheme. Fusion Rx produced compounded drugs, which are specially tailored medications that may be prescribed by a physician when the FDA-approved alternative does not meet the patient’s needs. Vahedi, the operator of Fusion Rx, and Kieffer, a marketer, allegedly paid commissions to marketers and some patients to obtain medically unnecessary compounded drugs to allow Fusion Rx to bill health care providers for those compounded drugs, many of which were reimbursed at rates much higher than average medications. To encourage patients to continue seeking the compounded drugs, Fusion Rx allegedly failed to charge copayments to patients. However, to avoid the scheme being uncovered in an audit, they also allegedly directed Fusion Rx staff to use gift cards to pay the patients’ copayments for them so that it would appear they made the required copayments. This conduct allegedly resulted in approximately $17 million in losses to health care providers while the defendants spent substantial sums of money on themselves, including Vahedi’s purchase of a 1963 Ford Mustang Cobra. Also charged in a related case was Joshua Pearson, 40, a marketer, of St. George, Utah, for his alleged receipt of illegal kickbacks from Fusion Rx, Vahedi, and Kieffer for patient referrals for compounded drugs. The cases are being prosecuted by Asssitant United States Attorneys Ashwin Janakiram and Alexander Schwab of the Major Frauds Section and Assistant United States Attorney Jonathan Galatzan of the Asset Forfeiture Section.
Amir Friedman, 54, an anesthesiologist, of Calabasas, California, was charged for his alleged participation in a conspiracy to commit honest services mail and wire fraud and Travel Act violations involving approximately $800,000 in kickbacks for compounded pharmaceutical drugs involving New Age Pharmaceuticals, Inc., located in Beverly Hills, California. The case is being prosecuted by Assistant United States Attorney Ashwin Janakiram.
Susan H. Poon, D.C., 54, a Southern California chiropractor out of Dana Point, California, was charged for her alleged participation in an approximate $2 million scheme to defraud Anthem, Aetna, and other Blue Cross Blue Shield Association affiliates.  Through this scheme, Poon allegedly submitted false and fraudulent claims for chiropractic services never provided, medical diagnoses never given, and office visits that never occurred.  Poon also allegedly submitted false and fraudulent prescriptions to a provider of durable medical equipment—or in-home medical devices that can cost thousands of dollars each—that relied on those false prescriptions in its reimbursement claims.  Employees and employee-dependents of the United Parcel Service and Costco Wholesale Corporation who allegedly never received the claimed services or sought the claimed medical equipment were named as patients in Poon’s false claims and prescriptions.  The case is being prosecuted by Assistant United States Attorney Daniel S. Lim of the Santa Ana Branch Office. 
Mahyar David Yadidi, D.C., a Southern California chiropractor, was charged with conspiracy to commit health care fraud for operating a scheme to defraud the International Longshore and Warehouse Union – Pacific Maritime Association health care benefit plan.  Yadidi allegedly defrauded the ILWU-PMA Plan through his chiropractic clinic, San Pedro Philips Chiropractic, by offering kickbacks to patients for attending the clinic and by billing the Plan for services that were not rendered to its patients, services that were not medically necessary, and services that were provided by unlicensed employees not qualified to perform them.  Yadidi allegedly continued to operate his scheme after he was terminated as an authorized provider by the ILWU-PMA Plan.  Ivan Semerdjiev, D.C., a chiropractor working for Yadidi, and Julian Williams, a personal trainer working for Yadidi, were also both charged in connection with this fraud conspiracy.  In total, Yadidi, Semerdjiev, and Williams submitted almost $5 million to the ILWU-PMA Plan in allegedly fraudulent claims.  The case is being prosecuted by Assistant United States Attorney Alex Wyman.
Darren Hines, D.C., a Southern California chiropractor, was charged with health care fraud for operating a scheme to defraud the International Longshore and Warehouse Union – Pacific Maritime Association health care benefit plan.  Hines allegedly defrauded the ILWU-PMA Plan through his chiropractic clinic, Advanced Alternative Health, by billing for services not rendered and services being provided by unlicensed employees who were not qualified to perform them, all after Hines was terminated as an authorized provider by the ILWU-PMA Plan.  Hines submitted over half a million dollars in allegedly fraudulent claims over a short period of time.  The case is being prosecuted by Assistant United States Attorney Alex Wyman. 
The charges and allegations contained in the indictments are merely accusations.  The defendants are presumed innocent until and unless proven guilty.
The Fraud Section leads the Medicare Fraud Strike Force (MFSF), which is part of a joint initiative between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country.  Since its inception in March 2007, MFSF maintains 15 strike forces operating in 24 districts and has charged nearly 4,000 defendants who have collectively billed the Medicare program for more than $14 billion.  In addition, HHS Centers for Medicare & Medicaid Services, working in conjunction with HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers.
Prescription Drugs
Financial Fraud
Health Care Fraud
Press Release Number: 
1 day ago - Those standards include general chapters <795> (Pharmaceutical Compounding – Nonsterile Preparations), <797> (Pharmaceutical Compounding – Sterile ...