Saturday, March 1, 2014

Press Release From United States Attorney's Office in Puerto Rico Regarding Federal Charges Relating to Compounded Medications

FOR IMMEDIATE RELEASE

February 27, 2014
SAN JUAN, P.R. – Yesterday, February 26, a Federal grand jury returned a fourteen count-indictment against four individuals for health care fraud and causing the misbranding and adulteration of prescription medications with intent to mislead and defraud, announced Rosa Emilia Rodríguez-Vélez, United States Attorney for the District of Puerto Rico.  The defendants are facing a forfeiture allegation of $225,929.21.
According to the indictment, from on or about January 1, 2010 through on or about September 24, 2011, Family Pharmacy submitted at least 554 false and fraudulent claims to Medicare, through MCS, totaling approximately $309,456.81, seeking reimbursement for adulterated/misbranded Levalbuterol and Budesonide, causing Medicare, through MCS, to disburse approximately $225,929.21.
Defendant Francisco A. Rivera-González was the President and owner of Family Pharmacy, located in the Municipality of Añasco, PR.  As part of the business activities of Family Pharmacy he submitted claims to Medicare, through MCS Classicare. Rivera-González caused the adulteration/misbranding of Levalbuterol and Budesonide provided to Medicare beneficiaries and subsequently billed to Medicare. Luis Roberto Jiménez-Feliciano was the owner and president of RJ Medcare, Inc. He facilitated and caused the adulteration/misbranding of Levalbuterol and Budesonide provided to Medicare beneficiaries. 
Defendant Francisco J. Cintrón-Acevedo was a licensed pharmacist and owner of Farmacia Cintrón, located in the municipality of Utuado, PR., and the Resident Agent in Charge of Franseb Inc. Cintrón-Acevedo facilitated and caused the adulteration/misbranding of Levalbuterol and Budesonide provided to the Medicare beneficiaries which were subsequently billed to Medicare. Defendant Derilyn Serrano-Bernacet was a pharmacy technician at Farmacia Cintrón. She illegally compounded Levalbuterol and Budesonide provided to Medicare beneficiaries, which were subsequently billed to Medicare.
“As part of the nation’s health care system, Medicare serves vulnerable citizens, specifically our elderly,” said United States Attorney, Rosa Emilia Rodríguez-Vélez.  “Today’s arrests show that we will not tolerate criminals who engage in fraudulent schemes which threaten and harm people’s lives and deplete the Medicare program of funds which are destined for our senior citizens, in order to enrich themselves.”
“The Food and Drug Administration, Office of Criminal Investigations will continue to vigorously protect the health and safety of consumers from misbranded or adulterated drugs,” said Ralph Culkin, Resident Agent in Charge of FDA, Office of Criminal Investigations in Puerto Rico.
“HHS-OIG will continue to support these types of investigations, especially when misbranded and adulterated drugs pose a threat to the public and are billed to the Medicare program”, said Thomas O'Donnell, Special Agent in Charge of the Office of Inspector General's New York Regional Office which also covers Puerto Rico.
The investigation was led by the Food and Drug Administration-Office of Criminal Investigations, with the collaboration of the Department of Health and Human Services, Office of the Inspector General (HHS-OIG).
The case is being prosecuted by Special Assistant U.S. Attorney Wallace A. Bustelo.  If found guilty, the defendants could face a possible sentence of (10) years in prison for the Health Care Fraud offense and fines of up to $250,000.   A criminal indictment contains only charges and is not evidence of guilt.  Defendants are presumed to be innocent unless and until proven guilty.

A tale of two countries: The path to pharmacist prescribing in the United Kingdom and Canada


                                                            
March 01, 2014
United Kingdom and Canada point the way
U.S. pharmacy practice may be caught in the middle of a perfect storm. A shortage of primary care physicians, which stands to be exacerbated by droves of newly insured Americans this year, raises the question of whether other health care providers could pick up some of the slack. The Affordable Care Act (ACA) calls for the creation of accountable care organizations, which have the potential to engage pharmacists as full members of the health care team and allow them, and all other members of the team, to perform at the top of their skill sets and licenses. The HITECH Act is driving up use of electronic health records, which better situates pharmacists to collaborate with other members of the health care team. 
Pharmacy practice is at a tipping point that could be the culmination of the profession’s efforts to gain provider status, prescribing authority, and overall expanded scope of practice, according to Rita Shane, PharmD, FASHP, FCSHP, Director of Pharmacy Services at Cedars–Sinai Medical Center in Los Angeles and Assistant Dean of Clinical Pharmacy Services at the University of California, San Francisco (UCSF) School of Pharmacy. 

Drug Compounding, Drug Safety, and the First Amendment

Drug Compounding, Drug Safety, and the First Amendment


Rebecca Dresser


Washington University in Saint Louis - School of Law

2013

Hastings Center Report, 43:9-10, 2013
Washington University in St. Louis Legal Studies Research Paper No. 14-02-07

Abstract:     

In September 2012, news broke of a developing drug disaster in the United States. Health authorities tracking a fungal meningitis outbreak linked the disease to a contaminated steroid injectable drug made by a company called the New England Compounding Center. The contaminated steroid was a compounded drug that had not been approved by the Food and Drug Administration. By the time health officials pinpointed the source of the outbreak, an estimated 14,000 people had been injected with the contaminated drug. By December 2012, thirty-nine had died of meningitis and hundreds more had been diagnosed with the disease and other drug-related conditions. Many factors contributed to this drug disaster. One was a decision by the United States Supreme Court. In a 2002 decision, the Court ruled that a 1997 federal law regulating drug compounding was unconstitutional. Because the law prohibited providers of compounded drugs from promoting their products through advertising and other means, the Court held that it impermissibly restricted commercial speech.

Accepted Paper Series


Not Available For Download

Date posted: March 1, 2014  

Suggested Citation

Dresser, Rebecca, Drug Compounding, Drug Safety, and the First Amendment (2013). Hastings Center Report, 43:9-10, 2013; Washington University in St. Louis Legal Studies Research Paper No. 14-02-07. Available at SSRN: http://ssrn.com/abstract=2402297

Contact Information

Rebecca Dresser (Contact Author)
Washington University in Saint Louis - School of Law ( email )
Campus Box 1120
St. Louis, MO 63130
United States

Updated List: Compounding Registered Outsourcing Facilities

Compounding Registered Outsourcing Facilities

FDA Issues 483 dated 2/4/ 2014 to Eastern Pharmacy,, Inc. Ocala, FL

Eastern Pharmacy, Inc., Ocala, FL

MUST READ!!! Federal Charges in Purerto Rico Involve Illegally Compounded Asthma Medications

[PDF]

3 February 28-March 2, 2014 - The San Juan Daily Star

www.sanjuanweeklypr.com/pdf/Feb-28-14/local.pdf
15 hours ago - that were illegally compounded and misbranded in various drug stores in three towns on the island. Authorities said the drug stores did not have the facilities to ...

Owners of Two Pharmacies in Puerto Rico face federal charges

2/28/14 - 4 Puerto Ricans face health care fraud charges [Saudi Press Agency (Saudi Arabia)]
SAN JUAN, Puerto Rico, Rabi'II 27, 1435, Feb 27, 2014, SPA Four people including the owners of two pharmacies have been arrested on federal health care fraud charges in Puerto Rico, AP reported.
U.S. Attorney Rosa Emilia Rodriguez says the suspects are accused of submitting at least 554 false claims to Medicare totaling more than $300,000. She said Thursday that they obtained the majority of the money back through reimbursements in a scheme that began in January 2010 and lasted nearly two years.
The suspects face a total of 14 charges.

! SAN JUAN, Puerto Rico, Rabi'II 27, 1435, Feb 27, 2014, SPA Four people including the owners of two pharmacies have been arrested on federal health care fraud charges in Puerto Rico, AP reported.
U.S. Attorney Rosa Emilia Rodriguez says the suspects are accused of submitting at least 554 false claims to Medicare totaling more than $300,000. She said Thursday that they obtained the majority of the money back through reimbursements in a scheme that began in January 2010 and lasted nearly two years.
The suspects face a total of 14 charges.
SPA 21:48 LOCAL TIME 18:48 GMT
quoted here

Killing Pain: Script by Script

Pain Management

Published: Feb 27, 2014 | Updated: Feb 28, 2014

NY Equine Safety Committee concerned about ''stacking'' of legal medications
2/28/2014

The simultaneous use of multiple therapeutic medications to treat the same ailment - a method referred to as stacking - has caused some concern among members of the New York racing community. The issue was brought up Thursday during a phone-in only meeting of the New York Racing Association’s
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Webinar Replay - Pharmacy Compounding:

An Update from The Joint Commission, the Food and Drug Administration (FDA), and the American Society of Health-System Pharmacists (ASHP)

February 28, 2014
Listen to the replay and view the speaker slide decks from the February 27, 2014 Webinar: Pharmacy Compounding: An Update from The Joint Commission, the Food and Drug Administration (FDA), and the American Society of Health-System Pharmacists (ASHP).