Saturday, September 30, 2017

Liberty Mutual Sues Doctors, Pharmacies Over Compounded Drugs

Liberty Mutual Sues Doctors, Pharmacies Over Compounded ...

WorkCompCentral (subscription)-22 hours ago 
Liberty Mutual also alleges that the compounded creams were manufactured in ... for individual patients, a violation of Food and Drug Administration regulations

Friday, September 29, 2017

OPINION: Prescription drug importation is dangerous for Alaskans

The Arctic Sounder-9 hours ago
Most drugs purchased through Canadian pharmacies aren't made in Canada, according to a new study by the National Association of Boards of Pharmacy

Off-Label Drug Bills Back on Track

P&T Community-7 hours ago
But some groups, such as the Academy of Managed Care Pharmacy (AMCP), criticized the draft guidance for limiting the provision of HCEI only to new drugs, ...

An open letter to Jeff Bezos–you are needed to disrupt the health ...

Quartz-12 hours ago
Pharmacies are basically in the brick and mortar stage of business. Although they accept prescriptions from physicians by email or fax, patients are expected to .

New California law protects diabetics, holds pharmacies accountable

ABC10-2 hours ago
The law makes it "unprofessional conduct" for pharmacies to have diabetic testing products from an unauthorized distributor or manufacturer. (Sept. 29, 2017).

Study finds Medicare 'DIR fee' legislation would save government ...

Pharmacy Today, American Pharmacists Association, hours ago
The results of a new study indicate that ending retroactive pharmacy payment reductions, or post point-of-sale pharmacy DIR fees, in Medicare Part D could save ...
Study: Ending DIR Fees Could Save Medicare Billions
Specialty Pharmacy Times-11 hours ago

PetSmart Launches Online Pharmacy Service hours ago
PetSmart has introduced PetSmart Pharmacy, an online-only pharmacy that offers convenient ordering and autofill for hundreds of prescriptions, Over The ...

Area pharmacy professors advocate ramping up opioid anecdote ...

Grand Forks Herald-1 hour ago
WEST FARGO—North Dakota pharmacists should be more active in prescribing the opioid antidote naloxone, according to instructors at a continuing education .

It's time to eliminate the secretive Pharmacy Benefit Manager pricing ...

The Hill-5 hours ago
With federal lawmakers introducing a variety of bipartisan, bicameral legislation throughout 2017 aimed at eliminating opaque and secretive Pharmacy Benefit ...

Essential Read!! A number of Philadelphia-area pain-management doctors, pharmacists, and related entities have been sued for prescribing $4.7 million in allegedly fraudulent compounded prescriptions

Philly-area doctors, pharmacists named in $4.7 million pain cream ... hours ago
A number of Philadelphia-area pain-management doctors, pharmacists, and related entities have been sued for prescribing $4.7 million in allegedly fraudulent ...

Informative Read!! According to the court documents, the unspecified "Pharmacy Benefits Administrator" paid the unnamed "Compounding Pharmacy" over $50 million

State Health Benefits Plan targeted in fraud case

Press of Atlantic City-5 hours ago
According to the court documents, the unspecified "Pharmacy Benefits Administrator" paid the unnamed "Compounding Pharmacy" over $50 million for
BREAKING: Price steps down as HHS secretary
Bowing to immense pressure over his use of private jets, HHS Secretary Dr. Tom Price resigned late Friday afternoon READ MORE

FDA Bulk Drug Substances Nominated for Use in Compounding under 503b as of July 2017

FDA Bulk Drug Substances Nominated for Use in Compounding under 503A as of July 2017

06/29/2017Vetoquinol N.-A.Center for Veterinary MedicineUnapproved New Animal Drug/AdulteredNot Issued *
08/25/2017Mega Pro InternationalDenver District OfficeCGMP/Dietary Supplement/Adulterated/MisbrandedNot Issued *
09/07/2017Newton Everett/WR Group Inc.Denver District OfficeNew Drug/MisbrandedNot Issued *
09/11/2017Vicare International (USA) INCLos Angeles District OfficeCGMP/Dietary Supplement/Adulterated/MisbrandedNot Issued *
09/12/2017Baptist Health Medical Towers Pharmacy and Infusion ServicesDallas District OfficeDrug Product/AdulteratedNot Issued *
09/12/2017First Pharma Associates LLC dba Riverpoint PharmacyLos Angeles District OfficeCompounding Pharmacy/Adulterated Drug ProductsNot Issued *
09/12/2017Shandong Vianor Biotech Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
09/18/2017Compounded Solutions in PharmacyNew England District OfficeCompounding Pharmacy/Adulterated Drug ProductsNot Issued *
Price to repay taxpayers for private jet use
HHS Secretary Tom Price said he would pay back taxpayers for the costs of his charter flights for business and personal use after receiving flak from lawmakers and President Donald Trump for the trips.  READ MORE

Thursday, September 28, 2017

4 days ago - West Virginia, with a population of 392, a single pharmacy received nearly nine ... The Drug Enforcement Administration (DEA) is attempting to revoke Miami

Perryville Pharmacist Sent to Prison for 10 Years, to Pay $850,000 for ...
1 day ago - This effort, dubbed Operation Pilluted, involved the extensive investigation of rogue practitioners, pharmacists, and other DEA Registrants, as well as the ...

Frier Levitt, LLC DEA Clarifies Its Guidance Regarding Pharmacies Forwarding Unfilled Electronic Prescriptions September 27, 2017

Brown Introduces Bill to Ensure Transparency, Accountability in DEA ...
4 hours ago - Brown Introduces Bill to Ensure Transparency, Accountability in DEA Quotas for Prescription Painkillers. Senator Secured Commitment from DEA to Reduce ...

Here's How DEA Agents Shield Themselves From Deadly Fentanyl ...
14 hours ago - Here's How DEA Agents Shield Themselves From Deadly Fentanyl. "Whereas heroin can kill you in milligrams, fentanyl can kill you in micrograms”. By George ...

Essential Read! Frier Levitt, LCC: Need for Heightened Vigilance Illustrated by Pharmaceutical Manufacturer Mallinckrodt's Settlement with DEA for $35 Million Based on Suspicious Orders
8 hours ago - Need for Heightened Vigilance Illustrated by Pharmaceutical Manufacturer Mallinckrodt's Settlement with DEA for $35 Million Based on Suspicious Orders 

OIG says FDA needs to boost efficiency to meet federal law

Food Safety News-17 hours ago
It established the Office of Dietary Supplement Programs (ODSP) in 2015 after sales of dietary supplements grew to $40 billion a year, up from just $4 billion two ...

FDA improves access to reports of adverse drug reactions hours ago
In addition to the FAERS database for drugs and biologics, the agency has adverse event reporting programs and databases for foods, dietary supplements, and ...

European agencies highlight high levels and banned substances in ... hours ago
European authorities have informed the EU of a number of dietary, food and sports supplements that contain either ingredients that exceed permitted levels or ...

Russian Court Orders Arrest of Doping Whistle-Blower Who Fled

New York Times-3 hours ago
Revelations by Grigory Rodchenkov, above, prompted investigations by the World Anti-Doping Agency and the International Olympic Committee into Russia ...
Russian Court Issues Arrest Warrant For Doping Whistle-Blower
RadioFreeEurope/RadioLiberty-11 hours ago
This $300 Billion Amazon Rumor Just Won't Die

Investor's Business Daily · 5 hours ago

Outsourcers Currently Compounding Six REMS-Protected Opioids

Inside Health Policy (subscription)-1 hour ago
At least six opioids that appear to be subject to Risk Evaluation and Mitigation Strategies with restricted distribution systems are currently being compounded b

Pharmaceutical Employee Admits Health Care Fraud Conspiracy Targeting State Health Benefits Programs-- Zappala recruited individuals in New Jersey to obtain very expensive and medically unnecessary compounded medications from an out-of-state pharmacy

Department of Justice
U.S. Attorney’s Office
District of New Jersey

Thursday, September 28, 2017

Pharmaceutical Employee Admits Health Care Fraud Conspiracy Targeting State Health Benefits Programs

CAMDEN, N.J. – A Northfield, New Jersey, man today admitted defrauding New Jersey state health benefits programs and other insurers out of millions of dollars by submitting fraudulent claims for medically unnecessary prescriptions, Acting U.S. Attorney William E. Fitzpatrick and New Jersey Attorney General Christopher S. Porrino announced.
Richard Zappala, 45, a pharmaceutical sales representative, pleaded guilty before U.S. District Judge Robert B. Kugler in Camden federal court to an information charging him with conspiracy to commit health care fraud.
According to documents filed in this case and statements made in court:
From January 2015 through April 2016, Zappala recruited individuals in New Jersey to obtain very expensive and medically unnecessary compounded medications from an out-of-state pharmacy, identified in the informations as the “Compounding Pharmacy.” The conspirators learned that certain compound medication prescriptions – including pain, scar, antifungal, and libido creams, as well as vitamin combinations – were reimbursed for thousands of dollars for a one-month supply. 
The conspirators also learned that some New Jersey state and local government and education employees, including teachers, firefighters, municipal police officers, and state troopers, had insurance coverage for these particular compound medications. An entity referred to in the informations as the “Pharmacy Benefits Administrator” provided pharmacy benefit management services for the State Health Benefits Program, which covers qualified state and local government employees, retirees, and eligible dependents, and the School Employees’ Health Benefits Program, which covers qualified local education employees, retirees, and eligible dependents. The Pharmacy Benefits Administrator would pay prescription drug claims and then bill the State of New Jersey for the amounts paid. 
Zappala and conspirators working under him recruited public employees and other individuals covered by the Pharmacy Benefits Administrator to fraudulently obtain compounded medications from the Compounding Pharmacy without any evaluation by a medical professional that they were medically necessary. In return, the pharmacy paid one of Zappala’s conspirators a percentage of each prescription filled and paid by the Pharmacy Benefits Administrator, which was then distributed to Zappala and other members of the conspiracy.
Once he had recruited an employee covered by the Pharmacy Benefits Administrator, Zappala would obtain the employee’s insurance information and fill out a Compounding Pharmacy prescription form.  He would select the compounded medications that paid the most without regard to their medical necessity. 
Zappala would then get the prescriptions signed by doctors who never evaluated whether the patients had a medical necessity for the compounded medication. The prescriptions were then faxed to Compounding Pharmacy, which filled the prescriptions and billed the Pharmacy Benefits Administrator.
Zappala paid money and other benefits to doctors to reward them for signing prescriptions.  He also paid recruiters under him and paid individuals with insurance coverage to reward them for agreeing to obtain prescriptions.
According to the information, the Pharmacy Benefits Administrator paid Compounding Pharmacy over $50 million for compounded medications mailed to individuals in New Jersey. 
As part of his plea agreement, Zappala must forfeit $1,492,918.19 in criminal proceeds he received for his role in the scheme and pay restitution of at least $4,310,232.76.  
Zappala faces a maximum penalty of 10 years in prison and a $250,000 fine, or twice the gross gain or loss from the offense. Sentencing is scheduled for Jan. 5, 2018. 
Eight other conspirators – Matthew Tedesco, Robert Bessey, Michael Pepper, Thomas Hodnett, Steven Urbanski, John Gaffney, Judd Holt, and George Gavras – have pleaded guilty to their roles in the scheme and await sentencing.
Acting U.S. Attorney Fitzpatrick credited agents of the FBI’s Atlantic City Resident Agency, under the direction of Special Agent in Charge Timothy Gallagher in Newark, IRS – Criminal Investigation, under the direction of Special Agent in Charge Jonathan D. Larsen in Newark, and the U.S. Department of Labor, Office of Inspector General, under the direction of Special Agent in Charge Michael C. Mikulka in New York, with the investigation leading to the guilty plea. He also thanked the Division of Pensions and Financial Transactions in the State Attorney General’s Office, under the direction of Attorney General Porrino and Division Chief Eileen Schlindwein Den Bleyker, for its assistance in the investigation.
Defense counsel:  Kevin E. Raphael Esq., Philadelphia, Pennsylvania
Press Release Number: 

FDA Says It Is Working On Compounding Policy Despite Inactive Reg List

FDA Says It Is Working On Compounding Policy Despite Inactive Reg List

Inside Health Policy · 4 mins ago

FDA Takes Important Steps to Stem the Tide of Opioid Misuse and Abuse

America is awash in immediate-release (IR) opioids. About 90 percent of all opioid pain medications prescribed – or 160 million prescriptions a year – are for IR formulations like hydrocodone and acetaminophen or oxycodone and acetaminophen combinations. Many people who are currently addicted to opioids became medically addicted. Their first exposure to opioids was from a legal prescription, and for many, that prescription was written for an IR formulation of these drugs. Many addicted patients may then move on to higher dose formulations or more accessible illegal street drugs. 

Labour will hold government to account for pharmacy supervision ...

Chemist+Druggist-6 hours ago
A Labour MP has branded plans to amend pharmacy supervision legislation as a “massive attack” on community pharmacy and vowed her party will fight them.

Forbes Names PillPack One of the Next Billion-Dollar Companies

Markets Insider-4 hours ago
MANCHESTER, N.H. and SALT LAKE CITY, Sept. 28, 2017 /PRNewswire/ -- PillPack, the largest e-commerce pharmacy in the United States, has been named ...

Suspended Jersey City pharmacist pleads guilty to tax charge hours ago
A Jersey City pharmacist whose license was suspended earlier this year has pleaded guilty to filing a false tax return by not reporting nearly $171,000 he ...

Amazon Could Aim to Disrupt Pharmacy Market, Bernstein Says hours ago
The e-commerce juggernaut just introduced new Amazon Echo products and now analysts are talking about the company entering the pharmacy space.

Atlantic County Man Admits To Millions In Healthcare Fraud ... minutes ago
Once recruited, Zappala obtained that employee's insurance information and filled out a Compounding Pharmacy prescription form, authorities said. They would ...

Feds net 9th conviction in $25M state benefits prescription scam minutes ago

Sun Pharma, Dr Reddy's ready to stave off pricing pressure

Business Standard-2 hours ago
... boost overall growth to a compound annual rate of 20 per cent for FY19-22,” ... Also, pharmacy chains and retailers in the US have consolidated their orders to .

Dr. James Kauffman arraignment set for Thursday

Dr. James Kauffman arraignment set for Thursday

Press of Atlantic City-19 hours ago
Guilty pleas for Linwood, Philadelphia men in federal prescription drug fraud ... Prosecutor's Office investigation into alleged prescription drug benefits fraud has .

Brooklyn court fines drug company $260 million for selling misbranded cancer drugs

Should Pharmacy Technicians Administer Immunizations?
17 hours ago - Idaho State Board of Pharmacy, ... One state has adopted rules to allow pharmacy technicians to administer immunizations if the ...