Thursday, October 26, 2017

Endo International sues FDA on drug compounding policy Reuters · 2 hours ago

Endo International sues FDA on drug compounding policy

Reuters · 2 hours ago
Endo Files Federal Lawsuit to Obtain FDA Compliance with Drug ...
PR Newswire (press release)-3 hours ago

Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s important efforts to address the opioid crisis


Today the Administration took a historic step to direct additional resources to help address the staggering human and economic toll created by the epidemic of opioid addiction. We thank President Trump for his leadership in further empowering public and private parties around the country to do everything possible to more forcefully address this complex public health crisis. We are committed to taking additional steps under the new declaration of a public health emergency to more forcefully confront this immense national tragedy. This includes taking aggressive steps to prevent new addictions and opioid-related deaths, and help those currently addicted regain control and restore them to their communities. Continue reading.

Trump declares opioid crisis a public health emergency; critics say plan falls short

NPR Trump Administration To Declare Opioid Crisis A Public Health Emergency

Manchin: Opioid epidemic “is a business plan”

Manchin: Opioid epidemic “is a business plan” | MSNBC

www.msnbc.com/kasie.../manchin-opioid-epidemic-is-a-business-plan-10790938278...
4 days ago - Joe Manchin introduced new legislation this week to combat drug companies as the DEA tries to gain control of the opioid epidemic. He now claims that the ...

On opioids, Trump World's plans have become 'such a mess'

On opioids, Trump World's plans have become 'such a mess' | MSNBC

www.msnbc.com/rachel...show/opioids-trump-worlds-plans-have-become-such-mess
6 days ago - “They are not ready for this,” a public health advocate said of an emergency declaration after talking to Health and Human Services officials ...

Breaching The 'Wall': Is The White House Encroaching On DOJ

Breaching The 'Wall': Is The White House Encroaching On DOJ ...

WABE 90.1 FM-48 minutes ago
“These cases reflect a new and disturbing facet of the opioid crisis in ... Bharara's remarks follow an MSNBC interview with Holder earlier this week, when Holder ...

In opioid crisis, emotional stories highlight the danger

In opioid crisis, emotional stories highlight the danger

Delmarva Daily Times-3 hours ago
The airing of a video about a young Accomack County woman who died last year as the result of opioid abuse left the crowd of 80-plus in the Great Hall at ..

Price tag of Ohio's opioid epidemic: Up to $8.8 billion a year The Columbus Dispatch-7 hours ago A new study of the state's opioid epidemic by Ohio State University researchers shows a staggering economic toll of $6.6 billion to $8.8 billion a year — about ...

Price tag of Ohio's opioid epidemic: Up to $8.8 billion a year

The Columbus Dispatch-7 hours ago
A new study of the state's opioid epidemic by Ohio State University researchers shows a staggering economic toll of $6.6 billion to $8.8 billion a year — about ...

Lawmakers to DEA: Use more legal muscle against opioids

Lawmakers to DEA: Use more legal muscle against opioids

Washington Post-18 hours ago
Lawmakers urged the Drug Enforcement Administration to seek more legal authority if it is needed to battle the nation's opioid epidemic, telling an official they ...

Trump to Declare Opioid Crisis a 'Public Health Emergency'

Trump to Declare Opioid Crisis a 'Public Health Emergency'

New York Times-1 hour ago
WASHINGTON — President Trump on Thursday will announce he is directing his Department of Health and Human Services to declare the opioid crisis a public ...

State suspends license of Bellingham pharmacy assistant for

State suspends license of Bellingham pharmacy assistant for ...

The Bellingham Herald-15 hours ago
The state has suspended the license of a Bellingham pharmacy assistant convicted of voyeurism in 2016. Marc A. Woodyard's credentials have been suspended ...

New standards add pharmacies in Medicaid

New standards add pharmacies in Medicaid

The Ledger-14 hours ago
TALLAHASSEE — To address “concerns and issues” with pharmacy networks, Medicaid officials have reduced maximum times and distances that patients can ...

Pharmacist linked to deadly meningitis outbreak cleared of murder CBS News-15 hours ago

Pharmacist linked to deadly meningitis outbreak cleared of murder

CBS News-15 hours ago
We weren't compounding anymore, we were manufacturing." ... The outbreak sparked calls for increased regulation of compounding pharmacies, which differ ...
Pharmacist in NECC meningitis outbreak case acquitted of murder
Pharmacy Today, American Pharmacists Association, pharmacist.com-2 hours ago

Pharmalittle: Feds probe Purdue again; compounding pharmacist cleared of murder

Pharmalittle: Feds probe Purdue again; compounding pharmacist cleared of murder

STAT · 3 hours ago

FDA slaps India API drugmaker Vital Labs with warning letter

Federal judge rules Trump can end cost-sharing subsidies

Federal judge rules Trump can end cost-sharing subsidies
In a strongly worded opinion, the federal judge refused to force the Trump administration to revive cost-sharing reduction subsidies that help low-income people with out-of-pocket healthcare costs, ruling that the Affordable Care Act did not create a permanent appropriation for the payments.  READ MORE

Wednesday, October 25, 2017

Must Read!! Compounder Can't Duck Drug Marketing Suit, Allergan Says - Law360

Compounder Can't Duck Drug Marketing Suit, Allergan Says - Law360

https://www.law360.com/.../compounder-can-t-duck-drug-marketing-suit-allergan-sa...
4 hours ago - ... alleging Imprimis Pharmaceuticals illegally manufactures and sells unapproved newdrugs under a drug compounding loophole in FDA regulations, saying it ...

Golden Handcuffs Shackle Pharmacists to High-Paying Jobs

Pharmacy Times-4 hours ago
Perhaps it began in high school, especially for the newest gen

Nov. 17 NCOIL Meeting to Cover Physician Dispensing, Compounded Drugs

Nov. 17 NCOIL Meeting to Cover Physician Dispensing, Compounded ...

https://ww3.workcompcentral.com/.../403b3c924f310afea80d47e7d3407f8a036191c...
17 hours ago - 17 NCOIL Meeting to Cover Physician Dispensing, Compounded Drugs. State: Arizona; Topic: WEST; - 0 views; - 0 shares. The National Conference of 

Breaking News!!! Pharmacist guilty of fraud, not murder, over US meningitis outbreak

Pharmacist guilty of fraud, not murder, over US meningitis outbreak

Reuters-29 minutes ago
FILE PHOTO: Former New England Compounding Center supervisory pharmacist Glenn Chin enters the federal court in Boston, Massachusetts, U.S., ...

Fourth person charged in compounding pharmacy prescription fraud case Gadsden Times

Fourth person charged in compounding pharmacy prescription fraud case

Gadsden Times · 52 mins ago

meningitis-etc: Outbreak Jury Moving Towards Verdict?

meningitis-etc: Outbreak Jury Moving Towards Verdict?: By Walter F. Roche Jr. BOSTON- Jurors gave the first hint they may be nearing a verdict in the racketeering trial of a druggist blamed f...

CBO: Bipartisan bill to stabilize insurance would reduce budget deficit

CBO: Bipartisan bill to stabilize insurance would reduce budget deficit
The bipartisan Senate bill to stabilize the individual insurance market and fund cost-sharing reduction payments to insurers would reduce the federal budget deficit by $3.8 billion from 2018 to 2027, according to the Congressional Budget Office.  READ MORE

U.S. lawmakers will not tackle healthcare this year, Ryan says -Reuters interview

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives


Chairman Walden and Ranking Member Pallone, thank you for the opportunity to testify today before the full committee.
The epidemic of opioid addiction that’s devastating our nation is the biggest crisis facing public health officials, FDA included.
As this crisis grew, many of us didn’t recognize the consequence of this threat. We missed opportunities to stem its spread. So we find ourselves at a tragic crossroad.
We have a crisis of such massive proportion that the actions we need to take are going to be hard.
We’ll need to touch clinical practice in ways that may make certain parties uncomfortable. This may include such steps as restrictions on prescribing, or mandatory education on providers. Long ago, we ran out of straightforward options. Continue reading.

Trump readies opioid plan amid worries it won't be enough

Trump readies opioid plan amid worries it won't be enough

ABC News-17 hours ago
President Donald Trump's long-awaited declaration that the opioid epidemic is a national emergency finally arrives this week, but some advocates are worried ...
What it would mean to declare the opioid crisis a national ...
Becker's Hospital Review-15 hours ago


Wave of addiction linked to fentanyl worsens as drugs, distribution ...

Washington Post-17 hours ago
As President Trump prepares to declare the opioid epidemic a national crisis, the law enforcement community is racing to contain the spread of fentanyl, which

The opioid crackdown is making life untenable for chronic pain ...

The opioid crackdown is making life untenable for chronic pain ...

Los Angeles Times-2 hours ago
President Trump recently said that he intends to declare the opioid crisis a national emergency. If he makes good on that promise, it will be the country's first 

America's opioid crisis: how prescription drugs sparked a national .

America's opioid crisis: how prescription drugs sparked a national ...

The Guardian-8 hours ago
Oxycodone is a narcotic pain reliever, an ingredient of painkillers that have contributed to the current opioid crisis. Photograph: Education Images/UIG via Getty ...

FDA tackles drug packaging and safety, with help from error reports

FDA tackles drug packaging and safety, with help from error reports

Pharmacy Today, American Pharmacists Association, pharmacist.com-22 hours ago
Pharmacists have a responsibility to report safety issues involving drug naming, labeling, and packaging, according to Chelsea M. Anderson, PharmD, MBA, ...

UPDATE 2-Express Scripts CFO Eric Slusser resigns

Reuters-14 hours ago
The pharmacy benefit manager's efforts to retain customers comes a week after its biggest client and health insurer Anthem Inc ended a 10-year contract with the ...

Concern about large pharmacy groups sparks ownership probe International-Pharmacy News-8 hours ago

Who'll face up to the pharmacy protection racket?

The Sydney Morning Herald-1 hour ago
Have you heard about the inquiry into the rules governing pharmacies and what they get paid? I'll let you in on a secret. It's secret, even though the Health ...

2 Minn. Pharmacists Disciplined for Illegally Accessing Medical Records

2 Minn. Pharmacists Disciplined for Accessing Medical Records of ...

KSTP.com-10 hours ago
Two pharmacists in Minnesota have been disciplined by the State Board of Pharmacyfor illegally accessing the private medical records of Prince. The data is ...

Imprimis Pharmaceuticals, Inc. (NASDAQ:IMMY) Experiences Heavy ...

Modern Readers-12 hours ago
The Company, through its Imprimis Cares program, owns, markets and dispenses a portfolio of compounded therapeutic in several therapeutic areas, including ...

Compounding pharmacy sales rep charged with fraud conspiracy WVTM13 · 2 hours ago--"Eodice worked for Northside Pharmacy, an Alabama company doing business as Global Compounding Pharmacy."

Compounding pharmacy sales rep charged with fraud conspiracy

WVTM13 · 2 hours ago

GOP lawmakers propose new conditions on health bill


Two top Republicans announced a bill Tuesday restoring federal subsidies to insurers that includes tough conditions sought by the White House.  READ MORE

Tuesday, October 24, 2017

Brick Township woman admits to defrauding $940K from township ... Press of Atlantic C

Salesman from New York charged in Alabama pharmacy fraud case AL.com - 2 hours ago

Tuesday, October 24, 2017 U.S. Attorney Charges NW Alabama Compounding Pharmacy Sales Representative in Prescription Fraud Conspiracy

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

FOR IMMEDIATE RELEASE
Tuesday, October 24, 2017

U.S. Attorney Charges NW Alabama Compounding Pharmacy Sales Representative in Prescription Fraud Conspiracy

BIRMINGHAM – The U.S. Attorney’s Office today charged a fourth sales representative for a Haleyville, Ala.,-based compounding pharmacy for participating in a conspiracy to generate prescriptions and defraud health care insurers and prescription drug administrators out of tens of millions of dollars in 2015.
U.S. Attorney Jay E. Town, FBI Special Agent in Charge Johnnie Sharp, U.S. Postal Inspector in Charge Adrian Gonzalez, 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 John F. Khin, and Internal Revenue Service, Criminal Investigation, Acting Special Agent in Charge James E. Dorsey announced the charges. 
Prosecutors filed an information in U.S. District Court charging PETER EODICE II, 34, of Webster, NY, with conspiracy to commit health care fraud, wire fraud and mail fraud, various counts of health care fraud for submitting fraudulent prescription reimbursement claims to Blue Cross Blue Shield of Alabama, and one count of aggravated identity theft for forging a prescription. In conjunction with the charges, prosecutors also filed a plea agreement with Eodice.
Eodice worked for Northside Pharmacy, an Alabama company doing business as Global Compounding Pharmacy. Global’s compounding and shipping facility was in Haleyville. The pharmacy did its prescription processing, billing and customer service at its “call center” in Clearwater, Fla.
Global hired sales representatives, including Eodice, who were located in various states and were responsible for generating prescriptions from physicians and other prescribers. To bill insurance providers, including Blue Cross Blue Shield of Alabama, for these prescriptions, Global contracted to enter the pharmacy networks of third-party administrators, known as “pharmacy benefit managers” or “PBMs.” These PBMs included Prime Therapeutics and Express Scripts Incorporated.
The court documents describe a conspiracy at Global that centered on generating and billing PBMs for fraudulent, often high-reimbursement prescriptions. To generate prescriptions, Global hired sales representatives who were married or related to doctors and other prescribers. Global also encouraged sales representatives to volunteer at doctors’ offices where they would review patient files and push Global’s products to patients. Global executives also frequently instructed employees to obtain high-reimbursing prescriptions that Global would fill and bill for reimbursement. One of the drugs that Eodice got for himself and his family members was a wound cream that cost over $29,000.
The plea agreement describes a Global executive instructing sales representatives to obtain certain prescriptions and, shortly after, Eodice obtained those prescriptions for himself and family members. Eodice also forged multiple prescriptions, according to the court documents.
When billing, Global engaged in various fraudulent practices, including automatically refilling and billing for prescriptions regardless of patient need, and routinely waiving co-pays to encourage patients to accept unnecessary medications and refills. 
As part of his plea agreement, Eodice agreed to forfeit $266,513 to the government as proceeds of illegal activity. 
Global paid sales representatives a base salary plus a monthly commission for prescriptions that they obtained, according to court documents.
The charges against Eodice follow charges brought by the U.S. Attorney’s Office earlier this year against three other Global sales representatives, Robin Gary Lowry, 49, of Columbus, Miss., Bridget McCune, 42, of Destin, Fla., and Kelley Norris-Hartley, 41, of Tuscaloosa.  All three were charged with conspiracy to defraud insurance plans and PBMs, along with various health care fraud counts for submitting fraudulent claims for payment to BCBS of Alabama. McCune also was charged with conspiring to solicit and receive kickbacks in return for referring prescriptions under Medicare and TRICARE, a U.S. Department of Defense health care program, and with money laundering for spending proceeds of the crimes. All three defendants pleaded guilty. Their sentencings are scheduled for early 2018.
FBI, U.S. Postal Inspection Service, U.S. Department of Health and Human Services Office of Inspector General, and U.S. Defense Criminal Investigative Service investigated the cases, which Assistant U.S. Attorneys Chinelo Dike-Minor and Nicole Grosnoff are prosecuting.
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Component(s): 

Tuesday, October 24, 2017 U.S. Attorney Charges NW Alabama Compounding Pharmacy Sales Representative in Prescription Fraud Conspiracy

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

FOR IMMEDIATE RELEASE
Tuesday, October 24, 2017

U.S. Attorney Charges NW Alabama Compounding Pharmacy Sales Representative in Prescription Fraud Conspiracy

BIRMINGHAM – The U.S. Attorney’s Office today charged a fourth sales representative for a Haleyville, Ala.,-based compounding pharmacy for participating in a conspiracy to generate prescriptions and defraud health care insurers and prescription drug administrators out of tens of millions of dollars in 2015.
U.S. Attorney Jay E. Town, FBI Special Agent in Charge Johnnie Sharp, U.S. Postal Inspector in Charge Adrian Gonzalez, 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 John F. Khin, and Internal Revenue Service, Criminal Investigation, Acting Special Agent in Charge James E. Dorsey announced the charges. 
Prosecutors filed an information in U.S. District Court charging PETER EODICE II, 34, of Webster, NY, with conspiracy to commit health care fraud, wire fraud and mail fraud, various counts of health care fraud for submitting fraudulent prescription reimbursement claims to Blue Cross Blue Shield of Alabama, and one count of aggravated identity theft for forging a prescription. In conjunction with the charges, prosecutors also filed a plea agreement with Eodice.
Eodice worked for Northside Pharmacy, an Alabama company doing business as Global Compounding Pharmacy. Global’s compounding and shipping facility was in Haleyville. The pharmacy did its prescription processing, billing and customer service at its “call center” in Clearwater, Fla.
Global hired sales representatives, including Eodice, who were located in various states and were responsible for generating prescriptions from physicians and other prescribers. To bill insurance providers, including Blue Cross Blue Shield of Alabama, for these prescriptions, Global contracted to enter the pharmacy networks of third-party administrators, known as “pharmacy benefit managers” or “PBMs.” These PBMs included Prime Therapeutics and Express Scripts Incorporated.
The court documents describe a conspiracy at Global that centered on generating and billing PBMs for fraudulent, often high-reimbursement prescriptions. To generate prescriptions, Global hired sales representatives who were married or related to doctors and other prescribers. Global also encouraged sales representatives to volunteer at doctors’ offices where they would review patient files and push Global’s products to patients. Global executives also frequently instructed employees to obtain high-reimbursing prescriptions that Global would fill and bill for reimbursement. One of the drugs that Eodice got for himself and his family members was a wound cream that cost over $29,000.
The plea agreement describes a Global executive instructing sales representatives to obtain certain prescriptions and, shortly after, Eodice obtained those prescriptions for himself and family members. Eodice also forged multiple prescriptions, according to the court documents.
When billing, Global engaged in various fraudulent practices, including automatically refilling and billing for prescriptions regardless of patient need, and routinely waiving co-pays to encourage patients to accept unnecessary medications and refills. 
As part of his plea agreement, Eodice agreed to forfeit $266,513 to the government as proceeds of illegal activity. 
Global paid sales representatives a base salary plus a monthly commission for prescriptions that they obtained, according to court documents.
The charges against Eodice follow charges brought by the U.S. Attorney’s Office earlier this year against three other Global sales representatives, Robin Gary Lowry, 49, of Columbus, Miss., Bridget McCune, 42, of Destin, Fla., and Kelley Norris-Hartley, 41, of Tuscaloosa.  All three were charged with conspiracy to defraud insurance plans and PBMs, along with various health care fraud counts for submitting fraudulent claims for payment to BCBS of Alabama. McCune also was charged with conspiring to solicit and receive kickbacks in return for referring prescriptions under Medicare and TRICARE, a U.S. Department of Defense health care program, and with money laundering for spending proceeds of the crimes. All three defendants pleaded guilty. Their sentencings are scheduled for early 2018.
FBI, U.S. Postal Inspection Service, U.S. Department of Health and Human Services Office of Inspector General, and U.S. Defense Criminal Investigative Service investigated the cases, which Assistant U.S. Attorneys Chinelo Dike-Minor and Nicole Grosnoff are prosecuting.
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Component(s): 

Outsourcer Compounding Opioids Recalls Products Due To Possible microbial contamination

Outsourcer Compounding Opioids Recalls Products Due To Possible ...

https://insidehealthpolicy.com/.../outsourcer-compounding-opioids-recalls-products-d...
3 hours ago - An outsourcer compounding four REMS-protected opioids is issuing a voluntary recall due to potential microbial contamination. The company, SCA ...