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

 

11/24/2020	10/16/2020	Aurolife Pharma, LLC	Division of Pharmaceutical Quality Operations I	CGMP/Finished Pharmaceuticals/Adulterated
11/24/2020	11/16/2020	Harmonic Nature S. de R.L. MI.	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
11/24/2020	11/19/2020	Liq-E S.A. De C.V.	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
11/20/2020	11/18/2020	Vibrant Health Care, Inc.	Center for Biologics Evaluation and Research (CBER)	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
11/19/2020	11/18/2020	Pro Breath MD, LLC dba Dentist Select and OraCare	Center for Drug Evaluation and Research | CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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

 

• 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

 

• 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...

 

Amazon Pharmacy not likely to disrupt drug fulfillment

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

 

Wade Walters testifies against doctor in MS pain cream fraud ...

www.clarionledger.com › news › local › 2020/11/17

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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MS pain cream scheme testimony: Doctor tried to hide ...

www.clarionledger.com › news › local › 2020/11/12

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

www.natlawreview.com › article › pharmacy-complian...

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 ...

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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 ..

 

sterile products compounding - Regulation and Licensing ...

www.rld.state.nm.us › uploads › FileLinks › STERILE_...

PDF

4 days ago — HAZARDOUS DRUG (HD) COMPOUNDING. YES. NO. 8. DOES HD COMPOUNDING OCCUR AT THIS FACILITY? ____. ____(IF NO, SKIP. TO NEXT SECTION).