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Saturday, February 28, 2015

The Florida Department of Health has fined an Ocala pharmacy $5,000 and ordered it to stop making sterile compounded drugs after state investigators found a slew of violations at the West Silver Springs Boulevard business.

  1. Local pharmacy faces $5K in fines for violations | Ocala.com

    www.ocala.com/article/20150228/ARTICLES/150229690
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    3 hours ago - The Florida Department of Health has fined an Ocala pharmacy $5,000 and ordered it to stop making sterile compounded drugs after state investigators found a  ...

Part 3: The price of pain: Indictments allege a massive compound cream scam: Prosecutors in the Orange County District Attorney's office call it one of the largest cases they've taken on: 20,000 exhibits, 15 defendants and more than $100 million in alleged overbilling in an alleged workers' compensation fraud scheme centered around compound creams and allegations of over $25 million in kickbacks to doctors, chiropractors and pharamcists to write, fill and bill for compounded pain creams (includes FBI recording, a chart of the players involved, pictures from the compounding pharmacy, and part of transcript with emails)

This is the third in a series on the compound cream industry. You can read Part One here and Part Two here.
Prosecutors in the Orange County District Attorney's office call it one of the largest cases they've taken on: 20,000 exhibits, 15 defendants and more than $100 million in alleged overbilling in an alleged workers' compensation fraud scheme centered around compound creams.
An Inland Empire businessman, Kareem Ahmed, is accused of masterminding the alleged scam. Prosecutors say he paid a dozen doctors, chiropractors and pharmacists a total of $25 million in kickbacks in exchange for writing, filling and billing for large numbers of compound cream prescriptions.
KPCC first reported on the indictments by the Orange County Grand Jury in June. The defendants are scheduled to be arraigned in Santa Ana on Friday.
What makes this case unusual was the volume of business, according to Assistant District Attorney Scott Zidbeck. more

Advisors Give FDA Nod To Put 26 Drugs On Non-Compounding List


Thursday, 26 February 2015
An advisory committee this week concurred with FDA's suggestion that 26 drugs be listed as unsafe or not effective for compounding, firming up a highly anticipated updated list that is key to the agency's implementation of the new compounding law.

FDA Can't Track Whether Pharmacists with traditional compounding facilities Compound For Specific Uses since they are not required to register with the agency

Friday, 27 February 2015
It would be tough for FDA to track whether a traditional compounding facility, which is not required to register with the agency, is limiting its compounding of drugs to specific indications, said an FDA official at a Pharmacy Compounding Advisory Committee meeting Tuesday (Feb. 24).

Fraud On Tricare By Compounding Company Complaints and Reviews


As a Tricare member, you may get a phone call from someone (In my case someone from India) who says he is with Tricare and he understands that I have ankle sores He wants to put me in touch with a compounding company that can make the exact medicine combination needed to cure my sores. He connects me to a lady who seems knowledgeable about my case until I finally get from her that she actually... Read more ›
Was this review helpful?0  0 

Second Question of the Day February 28, 2015 What are the rules and regulations regarding compounding "cosmetic products?" Are companies and corporations that spend the time to follow the FDA rules and regulations regarding cosmetics going to take action against compounding pharmacies that are replicating their products, mass producing and marketing these copies of products?


Quality of compounded bevacizumab varies

FEB 20, 2015 by Carl Danzig, MD
Samples from various U.S. compounding pharmacies showed significant variability and lower concentrations than bevacizumab acquired directly from Genentech, although the clinical implications of this are not yet known.
Editors' Choice

Medication Health Fraud Public Notification: Oxy ELITE Pro Super Thermogenic contains hidden drug ingredient

Medication Health Fraud Public Notification: Oxy ELITE Pro Super Thermogenic contains hidden drug ingredient

Medication Health Fraud Public Notification: Seven Slim contains hidden drug ingredient

Medication Health Fraud Public Notification: Seven Slim contains hidden drug ingredient

Medication Health Fraud Public Notification: Night Man contains hidden drug ingredient

Medication Health Fraud Public Notification: Night Man contains hidden drug ingredient

Medication Health Fraud Public Notification: Libigrow XXX Treme contains hidden drug ingredient

Medication Health Fraud Public Notification: Libigrow XXX Treme contains hidden drug ingredient

Medication Health Fraud Public Notification: Nine Slim contains hidden drug ingredient

Medication Health Fraud Public Notification: Nine Slim contains hidden drug ingredient

Essential Read for Pharmacists, Lawyers, and Consumers of Compounded and Repackaged Drugs: Copy of Indictment in Med Prep Consulting, along with owner Gerald Tighe and PIC Stephen Kalinoski with charges of introduced adulterated and misbranded drugs into interstate commerce with the intent to defraud and mislead the U.S. Food and Drug Administration and health care providers.

Second Question of the Day February 28, 2015 U.S. Attorney Loretta Lynch recently announced another major criminal indictment in the compounding industry against Med Prep Consulting. Lynch's nomination as the United States Attorney General was approved by a Senate Committee Last Week. Might we see the fraud and criminal activity in the compounding industry become an even higher priority at DOJ in the future?


Legislation Introduced in IL Relating to Compounding and Reimbursement Cost

  1. Bill Text: IL HB4079 | 2015-2016 | 99th General Assembly ...

    https://legiscan.com/IL/text/HB4079/2015
    19 hours ago - Provides that the Department shall regulate the drug pricing process used by pharmacy benefits ... 12, "Compounding" has the meaning ascribed to it in the.

Quote of the Day February 28, 2015 "The criminal law is a blunt tool to deal with routine industrial practices — even in cases as egregious as the New England one — and its remedies come too late for past victims of abuses. But until opportunistic politicians stop characterizing regulations as "red tape" that "kills jobs" and following Grover Norquist's promise to reduce health and safety agencies to a size where they can be drowned in the bathtub, public health will continue to be compromised." by Rena Steinzor, USAToday, Bad feds, Deadly Meds


Hot Topic! Essential Read! USA TODAY: Bad feds, deadly meds: Column Rena Steinzor 9:06 a.m. EST February 28, 2015 FDA must be equipped to regulate compounding pharmacies.

In December, the Department of Justice indicted 14 people who worked at the New England Compounding Center. The company manufactured drugs in insanitary conditions that produced a fungal meningitis outbreak that killed 64 people and made 751 gravely ill in 2012. One of the owners and a senior pharmacist face charges of racketeering and second-degree murder. more

Kudos to Ohio Board of Pharmacy for this Excellent Resource on the Legal Practice of Pharmacy in Ohio

Question of the Day February 28, 2015 How many state pharmacy boards already have in place a pecentage rule like the one below in Ohio that only allows 5 % of the pharmacy's total dollar amount of sales of patient-specific compounded prescriptions within the past twelve months? Since some states already have this type of law why are compounding pharmacies in such an uproar of the FDA allowing 30%?

A pharmacist may compound a drug pursuant to a request made by a prescriber, or by an agent of the prescriber, for a drug to be used by the prescriber for the purpose of the direct administration to patients in the course of the prescriber's practice if the drug is compounded and provided to a prescriber by a pharmacy as an occasional exception to the normal practice of dispensing drugs pursuant to patient specific prescriptions. The pharmacy shall only provide those compounded preparations where the total value of those compounded preparations does not exceed five percent of the pharmacy's total dollar amount of sales of patient specific compounded prescriptions within the past twelve months, the preparations are not commercially available to a prescriber, and the preparations are used to treat an emergency situation, an unanticipated procedure for which a time delay would negatively affect a patient outcome, or for diagnostic purposes. [OAC Rule 4729-9-25(A)

Report on Pain Management Clinics in Ohio - A Special Report (July 2011 - December 2014)

California Officials Increase Fine, Suspension For Avila In Masochistic Case | Paulick Report – Thoroughbred Horse Racing News

California Officials Increase Fine, Suspension For Avila In Masochistic Case | Paulick Report – Thoroughbred Horse Racing News

Women Need More Info About Compounded Hormones February 27, 2015 | Menopause By Sarah Bruyn Jones - See more at: http://www.obgyn.net/menopause/women-need-more-info-about-compounded-hormones#sthash.31nya8Xl.dpuf


Medication Health Fraud Public Notification: Germany Niubian contains hidden drug ingredient

Medication Health Fraud Public Notification: Germany Niubian contains hidden drug ingredient

Medication Health Fraud Public Notification: Tibet Babao contains hidden drug ingredient

Medication Health Fraud Public Notification: Tibet Babao contains hidden drug ingredient

Medication Health Fraud Public Notification: Black King Kong contains hidden drug ingredient

Medication Health Fraud Public Notification: Black King Kong contains hidden drug ingredient

House Approves Bill to Limit Commercial Compounding Operations

 ...

https://ww3.workcompcentral.com/.../0c0...
21 hours ago - Pharmacies in Idaho that aren't registered with the federal government as manufacturers would be prohibited from ..

Friday, February 27, 2015

Highly Recommend that all compounding pharmacists and attorneys that represent them get a copy and read the recently unsealed indictment against Med Prep Consulting, Inc. A list of the specific charges are found below, but the indictment should also be obtained and read

press release here

Med Prep Consulting, Inc.


Pending Counts

ATTEMPT AND CONSPIRACY TO COMMIT MAIL FRAUD
(1)
FRAUD BY WIRE, RADIO, OR TELEVISION
(2-3)
FRAUD BY WIRE, RADIO, OR TELEVISION
(5-11)
FRAUD BY WIRE, RADIO, OR TELEVISION
(13-16)
CONSPIRACY TO DEFRAUD THE UNITED STATES
(17)
INTRODUCTION INTO INTERSTATE COMMERCE OF DRUGS ADULTERATED BECAUSE CONTAMINATED BY FILTH
(18-22)
INTRODUCTION INTO INTERSTATE COMMERCE OF DRUGS ADULTERATED BECAUSE OF INSANITARY CONDITIONS
(23-27)
INTRODUCTION INTO INTERSTATE COMMERCE OF DRUGS MISBRANDED BECAUSE DANGEROUS TO HEALTH WHEN USED AS LABELED
(28-32)
INTRODUCTION INTO INTERSTATE COMMERCE OF DRUGS MISBRANDED BECAUSE OF FALSE AND MISLEADING LABELING
(33-37)

Updated on Alabama Pain Clinic vs. CENTERS FOR MEDICARE AND MEDICAID SERVICES, et al., 5:14-cv-2476-AKK filed in the Northern District of Alabama

February 27, 2015
by Sue Tuck Richmond

As previously reported here  and here (copy of complaint) the Alabama Pain Clinic sued the Center for Medicare and Medicaid Services (CMS) over billing changes for compounded drugs. The clinic claims the CMS cannot retroactively change reimbursement policies.   Today, as expected, the CMS filed a motion to dismiss based on a lack of subject matter jurisdiction.  The CMS argues that the complaint should be dismissed because, "under the Medicare statute, and pursuant to clear precedent from the Supreme Court and the Court of Appeals for the Eleventh Circuit, a court has jurisdiction over a Medicare dispute only after the plaintiff has presented its grievance to the Secretary, channeled its challenge through the Medicare administrative appeals process, exhausted its administrative remedies, and received a final decision of the Secretary[]" and in this case the plaintiffs have failed to do so.   The district court entered an order today giving plaintiff's until March 10, 2015 to respond to the motion to dismiss. CMS will then have until March 13, 2015 to reply once the Clinic files its response.

Stay tuned to see how this case turns out.

Canada Recall of API: Xenex Laboratories Inc. API - Meloxicam, Nystatin, Retinoic Acid, Omeprazole, Liothyronine Sodium, Levothyroxine Sodium, Azelaic Acid, Dichloroacetic acid sodium salt

  1. API - Azelaic Acid, Dichloroacetic acid sodium salt (2015-02-13) Recalled Products API - Azelaic Acid, Dichloroacetic acid sodium salt Lack of evidence product was fabricated specific to quality standard for drugs. Wholesalers and compounding pharmacies API - Azelaic Acid, Dichloroacetic acid...
    Posted:
    2015-02-13
    Type of communication:
    Recall
  2. API - Meloxicam, Nystatin, Retinoic Acid, Omeprazole, Liothyronine Sodium, Levothyroxine Sodium (2015-02-13) Recalled Products API - Meloxicam, Nystatin, Retinoic Acid, Omeprazole, Liothyronine Sodium, Levothyroxine Sodium Lack of evidence of temperature control for cold storage Wholesalers and compounding...
    Posted:
    2015-02-13
    Type of communication: 
Recall

Canada Recall: Apothecare (APC) Bisacodyl (2015-02-18)

Apothecare (APC) Bisacodyl (2015-02-18)

Report a Concern
Starting date:
February 18, 2015
Posting date:
February 25, 2015
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-43829
more

Health Canada Warns Canadians Not to Use Unregistered Bedbug Control Products

Canada halts imports of 16 drugs made in India

Health Canada halts import of drugs from two Indian factories over ‘data integrity’ concerns

Are you in compliance with the HIPAA Privacy and Security Rules? Audits most likely coming soon.

The Department of Health and Human Services Office for Civil Rights (“OCR”) will likely soon begin auditing individual covered entities for compliance with the HIPAA Privacy and Security Rules, according to OCR Director Jocelyn Samuels. The time frame for and the scope of these audits are presently unknown at this time. More details will be announced in the near future.

source ABA Health Law Section

Great Read! FDA Proposal to Regulate Laboratory Developed Tests Raises ... The National Law Review

  1. FDA Proposal to Regulate Laboratory Developed Tests Raises ...

    The National Law Review-1 minute ago
    Back in August, we wrote about the FDA's controversial plan to release draft guidance on a new regulatory framework for Laboratory Developed Tests (LDTs) ...

Legislators Want to Exempt Much of FDA's Funding from Future from austerity measures


Legislators Want to Exempt Much of FDA's Funding from Future ...
Regulatory Focus-22 hours agoShare
New legislation introduced in Congress would exempt nearly half of the US Food and Drug Administration's (FDA) budget from austerity measures meant to help ...
Bill Seeks to Protect FDA User Fees Against Sequestration
Medical Device and Diagnostics Industry-Feb 26, 2015
Explore in depth (3 more articles)

FDA’s Blizzard of Enforcement at Compounding Pharmacies Evident in GMP Warning Letters for FY 2014 By Joanne S. Eglovitch

FREE PREVIEW | Subscribers get full access to this article:   Free Trial »   Subscribe »

FDA’s Blizzard of Enforcement at Compounding Pharmacies Evident in GMP Warning Letters for FY 2014


Executive Summary

Inadequate control of contamination – in people, processes and places – was the dominant problem found in the 45 drug GMP warning letters that FDA issued in FY 2014. More than half went to compounding pharmacies.

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Ways & Means To Mark Up Broad Medicare Anti-Fraud Bill Thursday The House Ways & Means Committee will mark up Thursday (Feb. 26) a slightly tweaked version of sweeping Medicare anti-fraud legislation first introduced in December by health subcommittee Chair Kevin Brady (R-TX) and ranking Democrat Jim McDermott (WA).

The House Ways & Means Committee will mark up Thursday (Feb. 26) a slightly tweaked version of sweeping Medicare anti-fraud legislation first introduced in December by health subcommittee Chair Kevin Brady (R-TX) and ranking Democrat Jim McDermott (WA). here

A federal grand jury on Thursday indicted Mary Ann Stewart, 47, of Bossier City, La., on one count of health care fraud and four counts of lying to a grand jury; As part of his plea agreement, he admitted that he caused a loss of $200,000 to $400,000 to the federal health insurance programs. Stewart's indictment says the overall fraud cost the programs unspecified millions of dollars. Herndon is already serving 11 years and 3 months in prison based on his May 2012 guilty plea to prescribing 10,800 oxycodone tablets and 3,600 oxymorphone tablets to patients who didn't need the powerful painkillers for medical reasons.

  1. Pharmacy Choice - Pharmaceutical News - Federal grand ...

    www.pharmacychoice.com/News/article.cfm?Article_ID=1333571
    7 hours ago - A federal grand jury on Thursday indicted Mary Ann Stewart, 47, of Bossier City, La., on one count of health care fraud and four counts of lying to a grand jury.

February 27, 2015 Comparing Average Sales Prices and Average Manufacturer Prices for Medicare Part B Drugs: An Overview of 2013


Report (OEI-03-14-00520)

02-26-2015
Comparing Average Sales Prices and Average Manufacturer Prices for Medicare Part B Drugs: An Overview of 2013

WHY WE DID THIS STUDY

When Congress established average sales prices (ASPs) as the primary basis for Medicare Part B drug reimbursement, it also mandated that OIG compare ASPs with average manufacturer prices (AMPs) and directed CMS to substitute payment amounts for drugs with ASPs that exceed AMPs by a threshold of 5 percent. To comply with its statutory mandate, OIG has completed over 30 quarterly pricing comparisons. In April 2013, CMS began substituting payment amounts in accordance with its published price substitution policy, which currently applies to only certain drug codes with complete AMP data that exceed the 5-percent threshold in two consecutive quarters or three of the previous four quarters.

HOW WE DID THIS STUDY

We identified drug codes that had price substitutions on the basis of data from 2013, as well as codes that exceeded the 5-percent threshold but were not eligible for price substitution under CMS's current criteria. We also estimated the financial impact of reducing reimbursement for each of the drug codes that exceeded the 5-percent threshold.

WHAT WE FOUND

Under CMS's price substitution policy, 15 drug codes were subject to reimbursement reductions on the basis of data from 2013, saving Medicare and its beneficiaries an estimated $13 million from the fourth quarter of 2013 through the third quarter of 2014. We estimate that if CMS had expanded its price substitution criteria to include drug codes with complete AMP data in a single quarter or certain codes with partial AMP data, the agency could have generated almost $6 million in additional savings.

WHAT WE RECOMMEND

CMS has maintained a cautious approach to price substitutions and has expressed concern that expanding the criteria for price substitution may impede physician and beneficiary access to drugs. OIG agrees that CMS should always be mindful of access to prescription drugs; however, we continue to believe that CMS can achieve a better balance between safeguarding access to drugs and ensuring that Medicare and its beneficiaries do not overpay for drugs with ASPs that exceed the AMPs by the threshold percentage. Therefore, we recommend that CMS consider pursuing rulemaking to expand the price substitution policy to include at least some additional drug codes. CMS responded that more experience with the policy is needed before it is expanded.
Copies can also be obtained by contacting the Office of Public Affairs at Public.Affairs@oig.hhs.gov.
Download the complete report.

Rare Diseases at FDA: A Successful Year for Orphan Products

Rare Diseases at FDA: A Successful Year for Orphan Products

Pharmacy Compounding Advisory Committee Briefing Information for the February 23-24, 2015 Meeting of the Pharmacy Compounding Advisory Committee

Pharmacy Compounding Advisory Committee Briefing Information for the February 23-24, 2015 Meeting of the Pharmacy Compounding Advisory Committee

Progress made in settlement for meningitis-infected injections


Progress made in settlement for meningitis-infected injections
WNDU-TV-15 hours agoShare
The meningitis outbreak dates back to 2012, when officials learned that steroid injections from the New England Compounding Center were infected with the ...
Company involved in meningitis outbreak to pay more than $30M
WSBT-TV-12 hours ago
Explore in depth (2 more articles)

New FDA pharmacy compounding advisory committee convenes for first time

New FDA pharmacy compounding advisory committee convenes for first time
American Pharmacists Association, pharmacist.com - 13 hours ago
The newly configured, 14-member Pharmacy Compounding Advisory Committee (PCAC) for FDA convened for a 2-day meeting on February 22–24 at FDA ...

Second Question of the Day February 27, 2015 Anyone else notice that people are questioning some of the comments being posted on the CBS story? Also isn't it clear from some of the comments that some people are still not clear on whether compounded products are FDA approved are not?

DUBIAKW 
@NewDegas You have fallen for internet woo. The FDA is protecting you even if you fail to protect yourself.
 If this is a fake post by a compounder, you should be ashamed of yourself. Your fake sites don't fool me, either, even if they fool millions.
DODINY 
It seems to me a lot of these posts are created by the same people or related because they all tell a similar story and even have similar grammatical errors.  This just FURTHER demonstrates how corrupt this industry really is.  What I don't understand is why are these people not in jail.  Are these products FDA approved?
quoted from here

Question of the Day February 27, 2015 How many compounding pharmacies are shipping their unapproved drugs out of the United States? What is being done in law enforcement to catch and prosecute those who violate the law in this area? What should be done?


FDA Recalls, Market Withdrawals, & Safety Alerts Heritage Pharmaceuticals Initiates a Nationwide Voluntary Recall of Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial Due to a Lack of Sterility Assurance

Recalls, Market Withdrawals, & Safety Alerts Heritage Pharmaceuticals Initiates a Nationwide Voluntary Recall of Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial Due to a Lack of Sterility Assurance

Thursday, February 26, 2015

DEA Reannounces Job Openings for Diversion Investigators

Diversion Investigator

Do your career "Justice" by working with DOJ, which has been ranked in the Top 10 Best Places to Work in the Federal Government. Come and join the nation's law enforcement agency, where our most important resource is our people. The Department leads the nation in ensuring the protection of all Ameri
Salary:$52,668.00 - $82,840.00 / Per Year
Series & Grade:GS-1801-09/11
Location(s):DEA - US Locations, United States
Open Period:2/25/2015 to 2/27/2015
Announcement Number:D-OD-15-1279841-MP-ADD-R
Department:Department Of Justice
Agency:Drug Enforcement Administration
Position Info:Full Time - Permanent
Who May Apply:Status Candidates (Merit Promotion and VEOA Eligibles)