Thursday, July 2, 2020

7 days ago - Compounded drugs can serve an important role in meeting patients' medical needs that cannot be met by an FDA-appro... Tuesday, August 6, 2019 (0 Comments ..

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1 day ago - This type of fraud caused tricare to change its compounded drug reimbursement policy in may 2020. However, it is estimated that from 2020 to may 2020 over $2 ...
7 days ago - Vizient offers insights to FDA and USPTO on actions to increase access to compounded drugs and improve opportunities for new generics and biosimilars.

Market for Compounded Drugs Needs Greater Transparency

4 days ago - Many hospitals and medical practices rely on compounding pharmacies to produce drugs that meet patients' clinical needs when available medications ...

Report calls for limits on compounded bioidentical hormone therapy Posted 02 July 2020 | By Denise Fulton


https://www.raps.org/news-and-articles/news-articles/2020/7/report-calls-for-limits-on-compounded-bioidentical

Manufacturing FDA blasts California compounding pharmacy for facility 'contaminated with filth' by Kyle Blankenship | Jul 2, 2020 8:40am


https://www.fiercepharma.com/manufacturing/fda-blasts-california-compounding-pharmacy-for-facility-contaminated-filth
The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

  • The U.S. Food and Drug Administration (FDA) issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency's response efforts.
  • As part of continued action to protect the American public, the FDA is warning consumers and health care professionals about hand sanitizer products that contain methanol (a.k.a. wood alcohol), a substance often used to create fuel and antifreeze. Methanol is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has seen an increase in hand sanitizer products that are labeled as containing ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. State officials have also reported recent adverse events from adults and children ingesting hand sanitizer products contaminated with methanol, including blindness, hospitalizations and death.
  • Testing updates:
  • To date, the FDA has currently authorized 162 tests under EUAs; these include 136 molecular tests, 25 antibody tests, and 1 antigen test.

Coronavirus (COVID-19) Update: FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season

Today, the U.S. Food and Drug Administration further assisted health care providers around the country prepare for the upcoming flu season during the COVID-19 pandemic by issuing an emergency use authorization (EUA) for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19 in individuals suspected of COVID-19 by their healthcare provider to the U.S. Centers for Disease Control and Prevention (CDC). The FDA has previously issued EUAs to BioFire Diagnostics LLC and QIAGEN GmbH for their tests, which include many other respiratory organisms in addition to the viruses that cause flu and COVID-19.

“With the authorization of these tests, the FDA is helping address concerns in anticipation of this upcoming flu season during the COVID-19 pandemic, which might be especially worrying for some Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans,” said FDA Commissioner Stephen M. Hahn, M.D. “With just one swab or sample, combination tests can be used to get answers to Americans faster. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”

These combination tests work by testing a single sample from a patient for multiple respiratory diseases, such as COVID-19 and the seasonal flu which can show similar symptoms. There are several important advantages to this combination testing. Taking just one sample from a patient may help alleviate the need for multiple samplings, which means less discomfort for the patient with faster and...

Tuesday, June 30, 2020

Tennessee doctor, Mississippi nurse sentenced for fraud


https://www.dailyleader.com/2020/06/26/tennessee-doctor-mississippi-nurse-sentenced-for-fraud/

Houston Pharmacist, Wife Sentenced in $21M Workers’ Comp Fraud Case June 29, 2020


https://www.insurancejournal.com/news/southcentral/2020/06/29/573791.htm

Texas Doc Pleads Not Guilty In $6.7M Prescription Scam

https://www.law360.com/health/articles/1286732/texas-doc-pleads-not-guilty-in-6-7m-prescription-scam

Arkansas inmates to judge: Reopen our suit

Arkansas inmates to judge: Reopen our suit: Several Arkansas death-row inmates asked a federal judge Friday to reopen their lawsuit challenging the use of midazolam as the first of three drugs used in lethal injections, arguing that a better drug may now be available.

Who's been charged in prescription fraud case? MOLLY BILINSKI & CLAIRE LOWE Staff Writers Jun 26, 2020


https://www.pressofatlanticcity.com/gallery/whos-been-charged-in-prescription-fraud-case/collection_d4e0da0b-cef1-504e-8c7e-a18f18f1c550.html

Co-defendant of former local coach pleads guilty in federal court By: Staff

https://www.ktlo.com/2020/06/28/co-defendant-of-former-local-coach-pleads-guilty-in-federal-court/

Compounded drug market needs transparency, more regulatory certainty, says PewProviders, compounders, individual states and the FDA all have roles to play in stemming drug shortages during the pandemic.

https://www.healthcarefinancenews.com/news/compounded-drug-market-needs-transparency-more-regulatory-certainty-says-pew
19 hours ago - ... Equine Solutions After Finding Dirty Compounding Rooms, Potency Issues ... the letter notes that a batch of toltrazuril/pyrimethamine paste compounded for .

Friday, June 26, 2020

DEA searches 3 E. Kentucky pharmacies, charges city councilman after witness’ ruse BY JEREMY CHISENHALL JUNE 25, 2020 01:33 PM , UPDATED 10 HOURS 13 MINUTES AGO


https://www.kentucky.com/news/local/crime/article243793232.html

Florida pharmacists rules face physician objections


https://www.news-journalonline.com/news/20200625/florida-pharmacists-rules-face-physician-objections

Andover pharmacy reaches $11M settlement over alleged illegal prescriptions


https://www.bizjournals.com/boston/news/2020/06/25/ma-pharmacy-in-opioids-prescription-settlement.html

Former Marines and sailor plead guilty to $65 million Tricare fraud case ALEX RIGGINS, THE SAN DIEGO UNION-TRIBUNE16 HOURS AGO


https://taskandpurpose.com/news/tricare-fraud-miramar

5 Defendants In "Cream Scheme" Case To Have Separate Sentencings In Winchester Monday, June 22, 2020


https://www.chattanoogan.com/2020/6/22/410952/5-Defendants-In-Cream-Scheme-Case.aspx

'Compound King' Gets 10 Years For $22M Health Care Fraud


https://www.law360.com/employment/articles/1286966/-compound-king-gets-10-years-for-22m-health-care-fraud

Former Mississippi nurse receives 1½ years in prison for role in $7.2M pain cream fraud Lici Beveridge, Hattiesburg AmericanPublished 11:22 a.m. CT June 24, 2020


https://www.hattiesburgamerican.com/story/news/crime/2020/06/24/mississippi-nurse-sentenced-prison-pain-cream-fraud-freda-covington/3241381001/

New Florida Legislation Expands Pharmacist Scope of Practice Wednesday, June 24, 2020


https://www.natlawreview.com/article/new-florida-legislation-expands-pharmacist-scope-practice

Kyle Adams and two other Defendants Plead Guilty in $65 Million Health Care Fraud; Additional Charges Brought Against Alleged Ringleaders


https://www.stl.news/kyle-adams-and-two-other-defendants-plead-guilty-in-65-million-health-care-fraud/331649/

East Texas Doc Pleads Not Guilty In $6.7M Prescription Scam

https://www.law360.com/texas/articles/1286732/texas-doc-pleads-not-guilty-in-6-7m-prescription-scam

Who's been charged in prescription fraud case? MOLLY BILINSKI & CLAIRE LOWE Staff Writers Jun 24, 2020

"An ongoing federal investigation into prescription drug fraud has led to 30 people so far from Atlantic County and nearby being charged since August 2017."  Read more

Accused admits to role in Tricare fraud

Accused admits to role in Tricare fraud: LITTLE ROCK -- Albert Glenn Hudson of Little Rock admitted Wednesday in federal court in 2015, he participated with an Alexander doctor and a former Baxter County basketball coach to defraud Tricare, the federal government's health insurance program, of more than $12 million.

Margate doctor, Linwood man among three more indicted in health benefits scheme 2:09 pm June 25, 2020 by Lynda Cohen


https://breakingac.com/2020/06/margate-doctor-linwood-man-among-three-more-indicted-in-health-benefits-scheme/

Doctor and Nurse Sentenced for Conspiracy to Commit Health Care Fraud in Compounding Pharmacy Scheme

Department of Justice
U.S. Attorney’s Office
Southern District of Mississippi

FOR IMMEDIATE RELEASE
Wednesday, June 24, 2020

Doctor and Nurse Sentenced for Conspiracy to Commit Health Care Fraud in Compounding Pharmacy Scheme

Jackson, Miss. –   Dr. Thomas Edward Sturdavant, M.D., 56, of Cordova Tennessee, was sentenced Monday and Freda Cal Covington, RN, 55, of Hattiesburg, was sentenced today by Senior U.S. District Judge Keith Starrett for their roles in a conspiracy to commit health care fraud, announced U.S. Attorney Mike Hurst, Special Agent in Charge Michelle Sutphin of the Federal Bureau of Investigation (“FBI”) in Mississippi, and Special Agent in Charge Cyndy Bruce of the U.S. Department of Defense’s Criminal Investigative Service’s (“DCIS”) Southeast Field Office. 
Sturdavant was sentenced to 24 months in federal prison, followed by three years of supervised release, and ordered to pay a monetary judgment of $160,000, along with restitution in the amount of $1,628,409.  Covington was sentenced to 18 months in prison, followed by three years of supervised release. Co-defendant Dr. Shahjahan Sultan was sentenced on June 16, 2020 to 48 months in prison for his involvement in the conspiracy.
Beginning around May 2014, Sultan entered into a contract with a pharmacy located in Jackson County, Mississippi.  Pursuant to the contract, Sultan agreed to prescribe individuals expensive compound medications in exchange for the pharmacy agreeing to pay Sultan 35% of the reimbursements it received for the prescriptions Sultan authorized.
In September 2014, Dr. Sultan offered to pay Dr. Sturdavant $900,000 to perform telemedicine services and prescribe more expensive compounded medications that had no medical effectiveness.  Dr. Sturdavant also signed more than fifty prescriptions for the compounded medications for individuals he did not examine.  As a nurse, Covington helped further the conspiracy by identifying individuals in places like Jones County, Mississippi who had insurance that covered the expensive compounded medications.  She conducted cursory physical examinations of patients at places like gas stations and public playgrounds and falsified patient assessments for patients she knew did not need the expensive compounded medications. 
Sturdivant pled guilty before Judge Starrett on November 21, 2019, and Covington pled guilty on October 15, 2019.
Fallon Page, another nurse, pled guilty on November 21, 2019, to mail fraud for her involvement with having the unnecessary compound medications shipped to patients by the pharmacy.  She will be sentenced by Judge Starrett on July 7, 2020.
The case was investigated by the FBI and DCIS.  Assistant Chief Dustin M. Davis and Trial Attorney Sara E. Porter of the Criminal Division’s Fraud Section and Assistant U.S. Attorney Kathlyn R. Van Buskirk of the Southern District of Mississippi prosecuted the case.

Topic(s): 
Health Care Fraud

Tuesday, June 23, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • In a new FDA Voices, titled FDA maintains the pace of meeting its goals on applications for medical products during the pandemic, FDA Commissioner Stephen M. Hahn, M.D., explains that one of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the timely reviews of medical product applications despite a surge in volume of work and practical constraints that may impact our ability to conduct on-site inspections. The FDA has maintained the same pace of meeting its goals on review of applications for medical products during the pandemic that it has maintained in recent years.
  • The FDA is partnering with the Critical Path Institute (C-Path) and the National Institutes of Health’s National Center for Advancing Translational Sciences (NCATS) on the CURE Drug Repurposing Collaboratory (CDRC). CDRC is a forum for the exchange of clinical practice data to inform potential new uses of existing drugs for areas of high unmet medical need, advancing research in these areas. CDRC will focus on capturing relevant real-world clinical outcome data through the FDA-NCATS CURE ID platform. In a pilot project focused on COVID-19, CDRC will use data collected via the CURE ID platform to aggregate global clinician treatment experiences to identify existing drugs that demonstrate possible treatment approaches warranting further study.
  • A Consumer Update, titled Getting Smarter about Food Safety: The Pandemic and Lessons Learned, explains that throughout the COVID-19 pandemic, the experts at the FDA have learned valuable lessons that will help shape our work to create a more digital and transparent, as well as safer, food system for you and your family. In the coming weeks, the FDA will unveil the blueprint for the New Era of Smarter Food Safety, which lays out how we will use technology and modern approaches over the next decade to strengthen the ways we approach the safety of the nation’s food supply, every day and in times of crisis.
  • Testing updates:
  • To date, the FDA has authorized 145 tests under EUAs; these include 122 molecular tests, 22 antibody tests, and 1 antigen test.
Additional Resources:

Kill Shot A SHADOW INDUSTRY, A DEADLY DISEASE: By JASON DEAREN

https://www.penguinrandomhouse.com/books/611049/kill-shot-by-jason-dearen/

Pricey Compounded Medication at Center of $50 Million Fraud in New Jersey


https://news.bloomberglaw.com/health-law-and-business/pricey-medications-at-center-of-50-million-fraud-in-new-jersey