Friday, July 31, 2020

Ohio pharmacy board backtracks, withdraws rule barring use of hydroxychloroquine to treat coronavirus BY JUSTIN WISE - 07/30/20 08:43 AM EDT

https://thehill.com/policy/healthcare/509734-ohio-pharmacy-board-bans-use-of-hydroxychloroquine-as-coronavirus-treatment

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2 days ago - Starting on Thursday, Ohio pharmacies, clinics and other medical facilities will be prohibited from dispensing or selling the malaria drug Hydroxychloroquine, ...
4 days ago - Compounded medications are specialty medications mixed by a pharmacist to meet the ... Although compounded drugs are not approved by the Food and Drug .

Nurse practitioner admits to kickbacks

Nurse practitioner admits to kickbacks: A federal judge Tuesday accepted a nurse practitioner's guilty plea to a charge of violating the federal anti-kickback statute after she admitted scheming with her daughter and others to defraud Tricare, the military's health insurer.

Rx fraud case nets 4th plea of guilty

Rx fraud case nets 4th plea of guilty: A North Little Rock man on Wednesday became the fourth person since late June to plead guilty to conspiring to defraud Tricare, a federal health-care program, of more than $12 million by generating fake prescriptions for expensive compounded drugs.

N.J. Fraud Scheme Milked ‘Exorbitant’ Rates for Compounded Drugs

https://news.bloomberglaw.com/health-law-and-business/n-j-fraud-scheme-milked-exorbitant-rates-for-compounded-drugs

Glycolic acid, TCA among FDA's proposed additions to 503B bulk drugs list

https://endpts.com/glycolic-acid-tca-among-fdas-proposed-additions-to-503b-bulk-drugs-list/

New Jersey Public University Employee Admits Role in $5.3 Million Compounded Prescription Drug Scheme

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

FOR IMMEDIATE RELEASE
Wednesday, July 29, 2020

New Jersey Public University Employee Admits Role in $5.3 Million Compounded Prescription Drug Scheme

NEWARK, N.J. – An employee of a public university in New Jersey today admitted his role in a scheme to defraud public and private health benefits programs of at least $5.3 million for the billing of medically unnecessary compounded prescriptions, U.S. Attorney Craig Carpenito announced. 
John Cuffari, 58, of Cedar Grove, New Jersey, pleaded guilty by videoconference before U.S. District Judge John Michael Vazquez to an information charging him with conspiracy to commit health care fraud.
According to documents filed in this case and statements made in court:
Compounded medications are specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient. Although compounded drugs are not approved by the Food and Drug Administration (FDA), they are properly prescribed when a physician determines that an FDA-approved medication does not meet the health needs of a particular patient, such as if a patient is allergic to a dye or other ingredients in the prescription.
Between November 2014 and July 2016, Cuffari participated in a conspiracy that involved the submission of fraudulent prescriptions for compounded medications to public and private insurance plans. The scheme centered on the discovery that certain insurance plans paid for prescription compounded medications – including scar creams, wound creams, and metabolic supplements/vitamins – at exorbitant reimbursement rates.
Cuffari exploited this opportunity through working as a sales representative for several compounding pharmacies. In order to profit as a sales representative, Cuffari targeted individuals who had insurance plans that covered compounded medications and then convinced those individuals to obtain prescriptions for compounded medications, regardless of medical necessity, often by providing them with cash payments. In order to obtain prescriptions for compounded medications for some of the recruited individuals, Cuffari caused payments to be made to a New Jersey-based physician.
Once the prescriptions were written, they were filled by the compounding pharmacies with which Cuffari worked. The compounding pharmacies would then receive reimbursement from the insurance plans, and would pay Cuffari a percentage of the reimbursement amount.
As part of his plea agreement, Cuffari must forfeit $539,580 in criminal proceeds he received for his role in the scheme and pay restitution of at least $5,392,214. He faces a statutory maximum of 10 years in prison and a $250,000 fine, or twice the gross gain or loss from the offense. Sentencing is scheduled for Dec. 9, 2020.
U.S. Attorney Carpenito credited special agents of the FBI, under the direction of Acting Special Agent in Charge Joe Denahan in Newark, with the ongoing investigation leading to today’s guilty plea.
The government is represented by Assistant U.S. Attorney Sean M. Sherman of the United States Attorney’s Office, Opioid Abuse Prevention and Enforcement Unit in Newark.
Topic(s): 
Health Care Fraud
Component(s): 
Press Release Number: 
20-236

Mobile-Area Doctor Charged in Prescription Drug Billing Scheme

Department of Justice
U.S. Attorney’s Office
Northern District of Alabama

FOR IMMEDIATE RELEASE
Friday, July 31, 2020

Mobile-Area Doctor Charged in Prescription Drug Billing Scheme

BIRMINGHAM, Ala. – A Mobile-area Alabama doctor was indicted on Tuesday in a long-running investigation into a prescription drug-billing scheme involving a Haleyville, Ala.-based pharmacy, Northside Pharmacy doing business as Global Compounding Pharmacy.  U.S. Attorney Prim F. Escalona, Federal Bureau of Investigation Special Agent in Charge Johnnie Sharp, Jr., U.S. Department of Health and Human Services, Office of Inspector General, Special Agent in Charge Derrick L. Jackson, Defense Criminal Investigative Service Special Agent in Charge Cynthia Bruce, United States Postal Inspector in Charge, Houston Division Adrian Gonzalez, and Internal Revenue Service-Criminal Investigation Special Agent in Charge James E. Dorsey announced the charges. 
An 11-count indictment charges Dr. Michelle Martine Jackson, 53, of Fairhope, Alabama, with a conspiracy to receive kickbacks, a conspiracy to commit health care fraud and mail fraud, health care fraud, and aggravated identity theft.  According to the indictment, Dr. Jackson, who worked out of two clinics in Mobile, Alabama, received kickbacks in exchange for issuing medically unnecessary compounded drug and other prescriptions to be filled by Global Compounding Pharmacy.  Dr. Jackson issued medically unnecessary prescriptions to a Global employee Bonita Amonett, and her family and friends, to individuals with whom Jackson did not have a doctor-patient relationship, and to individuals with whom she had a doctor-patient relationship, but who did not need the drugs in question.   Ms. Amonett paid the kickbacks in the form of cash and free offices services to Dr. Jackson and a nurse practitioner, Brandy Lunsford.  According to court documents, both Ms. Amonett and Ms. Lunsford previously entered guilty pleas to paying and receiving kickbacks and health care fraud. 
Dr. Jackson’s indictment brings the total number of individuals who have been charged in this long-running investigation to 30, 24 of whom have previously entered guilty pleas.  Those who have previously pled guilty include two nurse practitioners and various Global employees, including its CEO, COO, a vice president of sales, an operations manager, a district manager, and multiple sales representatives. 
The maximum punishment for the 18 U.S.C. § 371 kickback conspiracy is 5 years in prison and a $250,000 fine.  The maximum punishment for the 18 U.S.C. § 1349 health care and mail fraud conspiracy charge is 20 years in prison and a $250,000 fine. The maximum penalty for health care fraud is 10 years in prison and a $250,000 fine.  The minimum and maximum penalty for the 18 U.S.C. § 1028A aggravated identity theft charge is 2 years in prison and a $250,000 fine. 
The FBI, HHS-OIG, DCIS, USPIS, IRS-CI, and a United States Attorney’s Office investigator investigated the cases, which Assistant U.S. Attorneys Chinelo Dike-Minor, Don Long, and Edward Canter are prosecuting.  The Veteran Affairs Office of Inspector General Criminal Investigations Division provided assistance in the investigation.
An indictment is merely an allegation and the defendant is presumed innocent until proven guilty beyond a reasonable doubt.

Updated July 31, 2020
23 hours ago - “While compounded drugs do not undergo premarket review for safety, effectiveness and quality, we recognize they can serve an important role for patients whose