Tuesday, November 24, 2020

 

5 days ago — FYI. NABP's Presentation "Preparing for FDA's Compounding MOU" Slides for the Board is Available at: https://nabp.pharmacy/wp-content/uploads 

 

Alliance for Pharmacy Compounding PAC Profile • OpenSecrets

1 day ago — Alliance for Pharmacy Compounding raised $117715 in the 2019-2020 election cycle. See the details.

 

3 hours ago — ... convicted for his role in a kickback scheme that involved writing prescriptions for compounded drugs, which are more expensive than off-the-shelf medications

 

3 days ago — prescription drug outlet for the purpose of dispensing a prescription order. (1) ... Compounded prescription drugs distributed to veterinarians for “office ..

 

4 days ago — Excluding vaccines, radiopharmaceuticals, oral drugs, compounded drugs, intravenous immune globulin products, and drugs that share a HCPCS code with a .

 

5 days ago — showing compounded drugs outside of the required potency range are considered “out of specification.” Pharmakon conducted its own internal potency testing.

 

4 days ago — The former owner of a Noblesville compounding pharmacy lost an appeal of his conviction and prison sentence related to the distribution of drugs that contained 

Compounding drugs scammer to repay $743,775

 

6 days ago — ... of Arkansas to generate fake prescriptions for expensive compounded drugs in ... The pharmacy had an exclusive contract with Tricare, which paid the drugs' 

Freehold salesman admits health care fraud; received over $145K in commissions

https://www.app.com/story/news/crime/2020/11/18/freehold-borough-man-pleads-guilty-health-care-fraud-received-over-145-000-commission/3767633001/ 

 

3 hours ago — Section 503A of the FDCA prohibits compounding pharmacies from distributing "inordinate amounts" of compounded drugs across state lines. According to the 

 Department of Justice

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

FOR IMMEDIATE RELEASE
Wednesday, November 18, 2020

Former Pharmacy and Marketing Company Sales Representative Admits Role in Compounded Prescription Drug Scheme

NEWARK, N.J. – A former pharmaceutical and marketing company sales representative today admitted his role in a conspiracy to defraud a New Jersey state health benefits program, U.S. Attorney Craig Carpenito announced.

Joshua Darstek, 38, of Freehold, New Jersey, pleaded guilty by videoconference before U.S. District Judge John Michael Vazquez to a superseding information charging him with conspiracy to commit health care fraud.

According to documents filed in this case and statements made in court:

Compounding is a practice in which a pharmacist or physician combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. The Food and Drug Administration does not approve compounded drugs and thus does not verify the safety, potency, effectiveness, or manufacturing quality of compounded drugs. Generally, a physician may prescribe compounded drugs when an FDA-approved drug does not meet the health needs of a particular patient.

Between May 2014 and January 2016, Darstek worked as a sales representative on behalf of two compounding pharmacies and a marketing company – referred to in the superseding information as the “Compounding Companies.”  He marketed and sold compounded drugs to physicians, including pain, scar, and wound creams and certain supplements and vitamins. The Compounding Companies paid Darstek based on a percentage of the reimbursement payments they received from health care benefit programs for each prescription that he referred to the compounding pharmacies. Darstek participated in a conspiracy that recruited patients, many of whom had prescription drug coverage under the New Jersey School Employee’s Health Benefits Program, to submit medically unnecessary prescriptions for compounded drugs to the pharmacies. Darstek caused physicians to write prescriptions for individuals with whom they did not have any interaction for purposes of determining that a prescription for a compounded drug was medically necessary.

The conspiracy to commit health care fraud count carries a maximum penalty of 10 years in prison and a $250,000 fine, or twice the gain or loss from the offense. As part of his plea agreement, Darstek must forfeit $148,500 in criminal proceeds and pay restitution of at least $594,639. Sentencing is scheduled for March 23.

U.S. Attorney Carpenito credited special agents of the FBI, under the direction of Special Agent in Charge George M. Crouch Jr. in Newark, and the Defense Criminal Investigative Service, under the direction of Acting Special Agent in Charge Patrick J. Hegarty, with the investigation leading to today’s plea.

The government is represented by Assistant U.S. Attorney Bernard J. Cooney, Acting Chief of the Opioid Abuse Prevention & Enforcement Unit.

Topic(s): 
Health Care Fraud
Component(s): 
Press Release Number: 
20-427

OIG to conduct risk assessment of CMS's oversight of pharmacies compounding drugs--expected completion date 2022

 

Medicare Part D Compounded Drugs

In 2016, OIG called attention to significant growth in spending for compounded drugs. Specifically, OIG found that Medicare Part D spending for compounded topical drugs grew by 625 percent during 2006—2015. OIG has been involved in an increasing number of fraud investigations related to compounded drugs. We will conduct a risk assessment of CMS's oversight of pharmacies compounding drugs for beneficiaries to determine whether systemic vulnerabilities affecting the integrity of Medicare Part D; specifically, we will assess the risk that pharmacies did not meet Federal and State requirements.

Medicare Part D Compounded Drugs

oig.hhs.gov › summary › wp-summary-0000539

 

Wednesday, November 18, 2020

HHS issues rare 'fraud alert' encouraging pharma to nix paid doctor speaker programs

 

Despite impressive data, FDA's coronavirus vaccine reviews will take weeks, not days, official says

 

 

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.

“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by...

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Amazon Pharmacy not likely to disrupt drug fulfillment

While the offering could boost convenience and transparency, industry observers didn't expect it to disrupt the pharmaceutical industry.

READ MORE >

Tuesday, November 17, 2020

Key facts in how compounding pain scheme evolved: Wade Walters testifies against doctor in MS compounded pain cream fraud case

 

17 hours ago — Wade Walters, a major player in a massive $510 million pain cream fraud, ... the volume of the fraudulent prescriptions the compound pharmacy was filling.
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5 days ago — One patient who was prescribed a compounded vitamin supplement as well as ... The day after she took the vitamin pill, she called Medworx pharmacy to ask what ... Mississippi pain cream scheme:Hattiesburg businessman Wade Walters ...

 

CMS & DEA Oversight: Pharmacy Compliance Issues

4 days ago — Pharmacy Compliance: What Do You Need to Know? ... Compound Medication Compliance – Compounding pharmacies face unique compliance burdens, and

 

Amazon Pharmacy News: What Drugs Are Available? How ...

3 hours ago — Compounded medications; Diabetic testing and administration supplies (e.g. test strips, glucose meters and pen needles); Medical devices (e.g. braces, insulin ..