Wednesday, February 14, 2018

Detroit pharmacist suspended after being convicted of $6.2 million ...

https://www.metrotimes.com/.../detroit-pharmacist-suspended-after-being-convicted-o...
2 hours ago - Detroit pharmacist suspended after being convicted of $6.2 million health care and wirefraud. Posted By Alysa Zavala-Offman on Wed, Feb 14, 2018 at 4:33 PM. click to enlarge. Shutterstock. Back in October 2017, Detroit pharmacist Imad Hussein Soueid was convicted of stealing nearly $6.2 million from health care ...

RoxSan Pharmacy Notifies Patients of Potential Breach of Unsecured ...

markets.businessinsider.com › News › Stock News
17 hours ago - SANTA MONICA, Calif., Feb. 13, 2018 /PRNewswire/ -- As part of its commitment to patient privacy, RoxSan Pharmacy ('RoxSan') notified 1049 patients of a po... ... As soon as the credit bureau confirms your fraud alert, the other two credit bureaus will automatically be notified. Equifax: 1-800-525-6285; www.equifax.com ...

"Steven M. Butcher, 39, a former pharmaceutical sales representative turned owner and operator of MedMax LLC, a marketing company for compounded medications, pleaded guilty before U.S. District Judge John Michael Vazquez in Newark federal court to an information charging him with conspiracy to commit health care fraud and violate the Anti-Kickback Statute." He Orchestrating $45 Million Dollar Compounding Pharmacy Scheme

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

FOR IMMEDIATE RELEASE
Wednesday, February 14, 2018

New York Man Admits Orchestrating $45 Million Dollar Compounding Pharmacy Scheme

NEWARK, N.J. – A North Tonawanda, New York, man today admitted running a large-scale scheme to defraud private and federally-funded health care benefit programs out of millions of dollars by submitting fraudulent claims for medically unnecessary compounded medications, U.S. Attorney Craig Carpenito announced.
Steven M. Butcher, 39, a former pharmaceutical sales representative turned owner and operator of MedMax LLC, a marketing company for compounded medications, pleaded guilty before U.S. District Judge John Michael Vazquez in Newark federal court to an information charging him with conspiracy to commit health care fraud and violate the Anti-Kickback Statute.
According to documents filed in this case and statements made in court:
Butcher admitted that from July 2014 through April 2016, he organized a large-scale scheme to defraud health insurance plans by submitting phony claims for medically unnecessary prescription compounded medications, including scar creams, pain creams, and metabolic supplements marketed by MedMax for certain compounding pharmacies. 
Through MedMax, Butcher and others targeted individuals covered by private and federally-funded insurance plans that paid for compounded medications and convinced these individuals to obtain them regardless of medical necessity. Butcher also admitted that from December 2014 through June 2015, he conspired with others to pay kickbacks to persuade individuals to bill TRICARE – a health care benefit program for members of the military and their families – for medically unnecessary compounded medications.
During the scheme, Butcher would either send prescriptions directly to a compounding pharmacy or to a billing distribution company, which would then refer the prescription to a particular compounding pharmacy and submit a claim to the appropriate health insurance plan on behalf of that pharmacy. In return, Butcher received anywhere between 40 and 53 percent of the reimbursement received for each paid claim. At that time, health insurance plans were reimbursing compounding pharmacies anywhere between $3,000 and $43,000 for each compounded prescription.
To maximize profit in the compounding scheme, Butcher recruited several individuals as “sales representatives” who were paid a certain percentage for each compounded medication that they caused to be billed to a targeted health insurance plan. If a sales representative was a direct beneficiary of a targeted health insurance plan, Butcher paid them to obtain medically unnecessary compounded medications for themselves or their family. In addition, Butcher paid sales representatives for any individual that they recruited to the scheme. 
For instance, Butcher recruited former pharmaceutical employee Peter Pappas, 45, of Drexel Hill, Pennsylvania. As a MedMax sales representative, Pappas received medically unnecessary prescriptions for himself and also recruited several other individuals, including other former pharmaceutical sales representatives Jason Cerge, 41, of Media, Pennsylvania, and Julie Andresen, 40, of Haddonfield, New Jersey. Cerge recruited an individual identified in the information as “CC-1,” a New Jersey resident who targeted TRICARE beneficiaries.
Butcher paid Pappas for each of his personal compounded prescriptions and for each medically unnecessary medication Cerge, CC-1, and Andresen caused to be billed to a targeted health insurance plan.
Butcher and other conspirators, including Pappas, Cerge, and Andresen, took advantage of their relationships with physicians and other health care professionals to get prescriptions.  For instance, Butcher used his relationship with an individual identified in the information as “Physician Assistant 1,” to request that Physician Assistant 1 prescribe several medically unnecessary compounded medications for TRICARE beneficiaries. Physician Assistant-1 agreed and Butcher and others profited from phony claims to TRICARE.
As part of his plea agreement, Butcher must forfeit $4,584,597.92 in criminal proceeds and pay restitution of at least $45 million.
Of the $45 million loss Butcher caused to health care benefit programs, at least $3 million was attributable to TRICARE. 
For the conspiracy to commit health care fraud charge, Butcher faces a statutory maximum of 10 years in prison. For the conspiracy to violate the Anti-Kickback Statute charge, Butcher faces a statutory maximum of five years in prison. Each offense is also punishable by a $250,000 fine, or twice the gross gain or loss from the offense. Sentencing is scheduled for May 18, 2018.
Pappas, Andresen and Cerge have all pleaded guilty to their roles in the scheme. Pappas and Cerge await sentencing. Andresen was sentenced Feb. 7, 2018 to 15 months in prison.
U.S. Attorney Carpenito credited special agents of the FBI, under the direction of Special Agent in Charge Timothy Gallagher in Newark; and the U.S. Department of Defense, Office of the Inspector General, Defense Criminal Investigative Service, under the direction of Special Agent in Charge Leigh-Alistair Barzey, with the ongoing investigation leading to today’s plea.
The government is represented by Assistant U.S. Attorneys Erica Liu and Vikas Khanna, Deputy Chief of the U.S. Attorney’s Office Health Care and Government Fraud Unit in Newark.
To date, the New Jersey U.S. Attorney’s Office has prosecuted 19 individuals involved in various compounding pharmacy schemes across New Jersey to defraud health care benefit programs, and has recovered more than $4 million through forfeiture and restitution. These schemes have caused a total loss of more than $70 million to the health care industry, which has affected state, federal and private health care benefit programs. 
The New Jersey U.S. Attorney’s Office reorganized its health care practice in 2010 and created a stand-alone Health Care and Government Fraud Unit to handle both criminal and civil investigations and prosecutions of health care fraud offenses. Since that time, the office has recovered more than $1.38 billion 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.
Defense counsel: Herbert L. Greenman Esq., Buffalo, New York
Topic(s): 
Health Care Fraud
Component(s): 
Press Release Number: 
18-061

Police: Grand Ledge pharmacist falsely prescribed medicine - Lansing

https://www.lansingstatejournal.com/story/news/local/...pharmacist.../333449002/
9 hours ago - CHARLOTTE - A Grand Ledge pharmacist faces two felony charges after allegedly forging a doctor's signature to prescribe medicine. Jeffrey Michael Fitzgerald, 51, currently awaits trial in Eaton County Circuit Court on one count each of third-degree child abuse and prescription fraud. Both charges are felonies. Fitzgerald ...

How to Buy Medicines Safely From an Online Pharmacy

Russian doping lab whistleblower accused of being recruited in ...

CBC.ca-4 hours ago
The World Anti-Doping Authority kept him in place for a reason, she added, because he had been "compromised" by foreign agents. ... The Canadian Centre for Ethics in Sport, which manages Canada's anti-doping program, told CBC News it is looking into the report, but was unable to respond with a statement by press ...

The Russian doping scandal is just another part of its disinformation ...

The Hill-2 hours ago
The Court of Arbitration for Sport (CAS) supported the December 2017 decision of the International Olympic Committee (IOC) to ban Russian athletes and the country's Olympic Committee from participating in the games due to Russia's decades-long practice of circumventing anti-doping programs and tests. Though Russia ...
Two Russian athletes not invited to 2018 Winter Olympics by mistake

Why Is It So Easy To Cheat At The Olympics?

Live Science-Feb 13, 2018
According to the Court of Arbitration for Sport (CAS), Saito tested positive for a diuretic called acetazolamide, which can be taken to hide the presence of performance-enhancing drugs and is one of more than 200 chemicals prohibited by the World Anti-Doping Agency. Saito's suspension is the first to occur during the 2018 ...
Japanese Olympic Athlete expelled for doping
Local Source-NHK WORLD-Feb 12, 2018
International-TASS-19 hours ago


Doping is rampant at the Olympics. Here's why.

Vox-4 hours ago
To punish Russia for its egregious state-sponsored doping of athletes at the 2014 Sochi Winter Olympics and 2016 Rio Olympics, the International Olympic Committee has forced Russian athletes to compete not as Russians but as “OARs,” or “Olympic Athlete from Russia.” As Vox's Zeeshan Aleem noted, it's an awkward ...

Potentially deadly drugs halted en route to Sullivan County

Bristol Herald Courier (press release) (blog)-19 hours ago
Fentanyl, which is described as being 50 to 100 times more potent than morphine, has been discovered cut, pressed and mixed into a number of other drugs, including heroin, cocaine and marijuana. An increase in fentanyl and heroin overdose deaths has been reported across the country, including in Northeast ...

The Effect of the DOJ Memo, "Limiting Use of Agency Guidance Documents in Affirmative Civil Enforcement Cases," On FDA Inspections of Compounding Pharmacies and Outsourcing Facilities

The Effect of the DOJ Memo, "Limiting Use of Agency Guidance ...

JD Supra (press release)-5 hours ago
For years, the Food and Drug Administration (FDA) has relied upon draft and final guidance policies as the basis of Form 483 inspectional observations. A recent memorandum issued on January 25, 2018 by the Attorney General clearly prohibits the use of guidance documents in civil enforcement cases to effectively bind ...

Insurance legislators reintroduce physician dispensing model law

Business Insurance-10 hours ago
It zeros in on physician dispensing and drug compounding in workers compensation — issues states are grappling with, NCOIL CEO Tom Considine told Business Insurance from his office in Manasquan, New Jersey. “We believe this is a hidden accelerator in health costs,” he said, echoing the sentiments of many in comp 

8 initiatives FDA would pursue under FY 2019 budget

Becker's Hospital Review-1 hour ago
Create a Center of Excellence on Compounding for Outsourcing Facilities to establish the outsourcing industry as a robust and reliable source for compounded products. 3. Foster more innovation and efficiency in device manufacturing by establishing a voluntary program where devicemakers can receive certification for ...

Gottlieb Outlines FY 2019 Budget Goals

Regulatory Focus-2 hours ago
FDA is proposing to create, as it did for oncology, a "Center of Excellence on Compounding for Outsourcing Facilities," with expanded FDA engagement with outsourcing facilities and states to help the pharmacy outsourcing industry grow to meet its intended function and adhere to higher quality standards to protect patient ...

Tuesday, February 13, 2018

02/13/2018AVpak  Acyclovir Tablet, USP, 400mg, 50ct Unit Dose  Product mix-upApace Packaging LLC
09/12/2017Jiangmen Nowadays Daily Goods Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
11/01/2017Guangzhou Baiyunshan Pharmaceutical Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
11/14/2017Bayer Pharma AGCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
02/02/2018Cosmecca Korea Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued 
02/06/2018Reishi D. International, Inc.San Francisco District OfficeCGMP/Dietary Supplement/Adulterated/MisbrandedNot Issued *

Florida cousins commit $2.6 million fraud together — and get ...

Miami Herald-8 hours ago
An emergency suspension order that the Florida Department of Health slapped on pharmacy technicians Annia Marrero and Zugeilys Castillo last month adds another link between the Miami-Dade cousins. From November 2013 through May 1, 2016, by their own admission, the pair committed $2.6 million in Medicare and ...

Walgreens keeps its eye on the drug supply chain, as CVS goes its ...

CNBC-4 hours ago
The Wall Street Journal reported Monday that Walgreens Boots Alliance is in talks to acquire the portion of major drug distributor AmerisourceBergen it doesn't already own. Rival pharmacy chain CVS Health is taking a different approach with its planned acquisition of health insurer Aetna. Amazon is partnering with J.P. ...
Report: Walgreens considering bid for AmerisourceBergen
Philadelphia Business Journal-7 hours ago

Amerisource deal may not keep Walgreens competitive: analysts

Reuters-8 hours ago
(Reuters) - Walgreens' potential deal for drug distributor AmerisourceBergen will boost its cash flow and push it deeper into a lucrative specialty pharmacy market, but may fail to keep it competitive in an evolving U.S. healthcare sector, analysts said. A deal would not be a surprise, but analysts noted that it might cost ...

Pharmacy board weighs in on plan aimed at curbing opioid crisis

Pharmacy Today, American Pharmacists Association, pharmacist.com-9 hours ago
In Iowa, a bill introduced by House Republicans would require doctors and pharmacists in Iowa to use the Prescription Monitoring Program (PMP). At present, only 45% of prescribers in the state are registered to use the

Statement from FDA Commissioner Scott Gottlieb, MD, on ...

FDA.gov-47 minutes ago
The Center would provide much-needed education and training to improve product quality, safety and purchaser confidence, and help the FDA adjust its regulatory oversight to better match the scope of production of an individual compounding pharmacy. The FDA would work with industry to improve manufacturing ...

Walgreens looks at buying out AmerisourceBergen: WSJ

FDA Proposes to Require Electronic Submission of Certain Postmarketing Safety Reports for Approved New Animal Drugs


The U.S Food and Drug Administration today proposed a rule to require animal drug sponsors to submit to the agency certain adverse drug experience and product manufacturing defect reports on Form FDA 1932 in electronic format. Receiving these postmarketing safety reports electronically allows the agency to more rapidly review and identify emerging safety problems and notify veterinarians and animal caretakers about safety signals.

Read entire press release.

Monday, February 12, 2018

Beacon of light: Healthcare additions in budget law pleasantly surprise providers
The Bipartisan Budget Act, passed early Friday following a short-lived government shutdown, includes Congress' most significant healthcare legislation since the 21st Century Cures Act.  READ MORE

Purdue Pharma finally stops marketing opioids to physicians—and cuts 200-plus representatives in the process

Even as the U.S. opioid crisis deepened and lawsuits flourished, Purdue Pharma continued to market Oxycontin to doctors. But no longer. The company said last week that it will stop promoting its opioid drugs to physicians.

Friday, February 9, 2018

AmerisourceBergen gets US subpoena regarding Memphis…

Brinkwire (press release)-3 hours ago
Feb 6 – AmerisourceBergen Corp on Tuesday said it received a grand jury subpoena from U.S. prosecutors seeking documents related to laboratory testing procedures at a facility that produces around half of the compounded drugs it supplies. The U.S. drug distributor also said it expected to take a $60 million hit to its core ...

Trump Says He Will Focus On Opioid Law Enforcement, Not Treatment

US budget deals grants $1.5 billion for opioid-addicted babies ...

Reuters-2 hours ago
The action this year was part of a broad congressional budget agreement that includes about $6 billion for opioid and mental health issues. Though little noticed in the larger debates over defense and domestic spending, the section of law called the Family First Prevention Services Act fills more than 100 pages of the ...

Lawmakers lay out plan to combat opioid abuse in Iowa

DesMoinesRegister.com-14 hours ago
A House Republican plan to combat opioid addiction in Iowa would put limits on opioid prescriptions, implement Good Samaritan laws for those who report overdoses and require physicians to use an electronic tracking service for prescription opioids. “This affects all socio-economic groups, and, as I think ...

FDA Weaponizes 'Opioid' Label Against Kratom Consumers

Forbes-4 hours ago
The U.S. Food and Drug Administration released a statement on Tuesday afternoon from Commissioner Scott Gottlieb, MD, declaring that kratom, a southeast Asian herbal medicine, contains naturally-occurring plant alkaloid chemicals that are predicted by unpublished computer models to be opioids.
Budget deal approved, includes significant changes for healthcare
After a five-hour shutdown, Congress early Friday morning passed a massive budget deal that touches virtually every sector of the healthcare industry.  READ MORE

Thursday, February 8, 2018