Tuesday, June 2, 2015

2015 LiquidCapsule Manufacturing, LLC 5/15/15

2015 LiquidCapsule Manufacturing, LLC 5/15/15

CVM Updates FDA Regulation to Help Ensure Judicious Use of Antibiotics in Food-Producing Animals

CVM Updates FDA Regulation to Help Ensure Judicious Use of Antibiotics in Food-Producing Animals

Animal Drug Approvals June 2015 Update (Green Book)

Drug Industry Takes Issue With FDA Interpretation Of Compounding Law

The Pharmaceutical Research and Manufacturers of America says it was "perplexed and troubled" over FDA's interpretation of the Drug Supply Chain Security Act (DSCSA) laid out in an October guidance that would allow states to impose their own standards, requirements, or regulations with respect to wholesale drug distributors as long as they do not fall below the minimum standards established by federal law.

Judge temporarily bars new telemedicine rule in Texas



Telemedicine company Teladoc may continue—for now—to treat patients in Texas remotely without having physicians meet them face to face first, a federal judge decided Friday. READ MORE

MediMix, identified as a top biller of compounding pain prescriptions, settles with DOJ under False Claims Act for $3,775,458 for knowingly billing the government (Tricare) for compounded drugs that came from an improper referral source

Department of Justice
U.S. Attorney’s Office
Middle District of Florida

FOR IMMEDIATE RELEASE
Monday, June 1, 2015

United States Settles False Claims Act Allegations Against Jacksonville-Based Compounding Pharmacy

Jacksonville, FL – United States Attorney A. Lee Bentley, III announces today that the United States has settled allegations that a Jacksonville-based compounding pharmacy knowingly billed the government for compounding pain prescriptions that came from an improper referral source.  The allegations resolved included liability under the False Claims Act (FCA).
The government has reached a settlement with the defendant, MediMix, and the top-referring physician – Dr. Ankit Desai.  In reaching this settlement, the parties resolved allegations that, from January 1, 2009, until December 2014, Dr. Desai sent hundreds of prescriptions to MediMix.  These prescriptions were not appropriately reimbursable because Dr. Desai was married to a Senior Vice President at MediMix. Healthcare providers are generally prohibited from referring business to entities where they have a financial interest.  The government agreed to accept $3,775,458 to resolve these allegations.
Today’s settlement involved false claims submitted to the TRICARE program.  This case was developed by proactively mining health care reimbursement data.  In mining through this data, MediMix was identified as a top biller of compounding pain prescriptions.
“The United States Attorney’s Office is committed to protecting TRICARE and other federal health care programs from fraud,” said U.S. Attorney Bentley.  “By bringing FCA cases such as this, we recover funds obtained through fraud and deter others from attempting similar schemes.”
"This settlement highlights another step forward by the Defense Criminal Investigative Service (DCIS) and its law enforcement partners to protect the integrity of the Department of Defense (DoD) health care program," said Special Agent in Charge John F. Khin, Southeast Field Office.  "Fraud and abuse by pharmacies and medical providers which bill for compounded pain prescriptions is a significant threat to the DoD health care system.  TRICARE beneficiaries must be made aware that any medications that are not individually prescribed or dispensed by a bona fide treating physician for a specific medical condition can be ineffective or unsafe."
"This settlement is demonstrative of our joint efforts to investigate allegations of health care fraud, and is a strong example of how collaborative efforts lead to success," stated Assistant Special Agent in Charge Lawrence Koleff with the FBI Jacksonville Division.
This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $24 billion through False Claims Act cases, with more than $15.3 billion of that amount recovered in cases involving fraud against federal health care programs.
This case was investigated by Defense Criminal Investigative Service, the Federal Bureau of Investigation, the Program Integrity Office at the Defense Health Agency, and Assistant United States Attorney Jason Mehta.
The claims resolved by this settlement are allegations only, and there has been no determination of liability.

Will the Pharmacy Bubble Really Burst?

  1. Will the Pharmacy Bubble Really Burst?

    Pharmacy Times (blog)-36 minutes ago
    Pharmacists have witnessed the explosion of new pharmacy schools and subsequent growth in the number of pharmacy graduates. So far, the market has ...

Tricare users should be careful with compound medicines - Military - Mobile Adv

Tricare users should be careful with compound medicines - Military - Mobile Adv

Local law firm comments on settlement reached in tainted steroid - ABC57 News - See the Difference Michiana

Local law firm comments on settlement reached in tainted steroid - ABC57 News - See the Difference Michiana

Fla. Compounding Pharmacy Pays $3.8M To Settle FCA Suit Law360‎ - 5 hours ago