view complaint here. A copy of the Request for Temporary Restraining Order and Memorandum in Support can be found in PACER filed in the Eastern District of Missouri. The court has not set a hearing yet.
Thursday, August 28, 2014
Breaking News: Concierge Compounding Pharmaceuticals Inc. v. Express Scripts Inc.: A Lawsuit seeking to Stop Express Script from Terminating a Compounding Pharmacy from its Network-hearing set for tomorrow August 29, 2014
View Motion
View Memo of Law in Support of Motion
View Complaint for Injunctive Relief
Great Read: One Doctor's Answer to Office Use Compounded Medications--Questions to Consider
08/28/2014 , DPM
In-Office Compounding
In-Office Compounding
In-office compounding has been around a long time.
There is nothing wrong with compounding selected
pharmaceutical ingredients in your office for
patient treatment. The issue your question raises
is not about Stark Law. It should be about medical
liability, kick-back laws, ethics, and not
jeopardizing your in-network medical status with
payers.
1. Liability is a major issue. When a pharmacist
dispenses a drug to a patient, they hold 100% all
patient liability for safety around allergies,
drug to drug interactions, contraindications and
side effect profile. The pain creams sound pretty
simple but most of them have 5-8 active
ingredients (including CII and CIII drugs) and the
bases contain over 25-30 ingredients.
Although the systemic exposure is less than oral,
there is still exposure and it varies depending on
skin type (elderly and children). When there is an
issue with the medication you dispensed, you are
the one the patient calls for immediate solution.
Due to this, you will also need to have a 24 hour
hot line to field non-911 issues. The companies
that are doing this shell game are passing all
liability on to you so be sure to increase your
liability coverage with the money you gained from
playing pharmacist. This is not worth my time.
2. Price gouging: The company is charging
insurance companies ridiculous amounts of money
and passing a fraction of that revenue to you.
Just remember that when a patient’s insurance gets
billed thousands for the pain cream, you will be
the one the patient comes running to. It usually
presents itself as a patient carrying an EOB
yelling, “you charged my insurance $3,500 for that
cream.”
There is nothing wrong with compounding selected
pharmaceutical ingredients in your office for
patient treatment. The issue your question raises
is not about Stark Law. It should be about medical
liability, kick-back laws, ethics, and not
jeopardizing your in-network medical status with
payers.
1. Liability is a major issue. When a pharmacist
dispenses a drug to a patient, they hold 100% all
patient liability for safety around allergies,
drug to drug interactions, contraindications and
side effect profile. The pain creams sound pretty
simple but most of them have 5-8 active
ingredients (including CII and CIII drugs) and the
bases contain over 25-30 ingredients.
Although the systemic exposure is less than oral,
there is still exposure and it varies depending on
skin type (elderly and children). When there is an
issue with the medication you dispensed, you are
the one the patient calls for immediate solution.
Due to this, you will also need to have a 24 hour
hot line to field non-911 issues. The companies
that are doing this shell game are passing all
liability on to you so be sure to increase your
liability coverage with the money you gained from
playing pharmacist. This is not worth my time.
2. Price gouging: The company is charging
insurance companies ridiculous amounts of money
and passing a fraction of that revenue to you.
Just remember that when a patient’s insurance gets
billed thousands for the pain cream, you will be
the one the patient comes running to. It usually
presents itself as a patient carrying an EOB
yelling, “you charged my insurance $3,500 for that
cream.”
Another Compounding Sales Representative Job Opening-Tulsa, Oklahoma
Compounding Pharmaceutical Representative - Tulsa
tulsa.craigslist.org › all jobs › healthcare jobs
15 hours ago - ... http://apothecarytulsa.com Email all resumes. Company Overview: Lees Specialty Compounding Inc. - The ESOP parent company of The Apothecary Shoppe.FDA Animal Veterinary Draft Guidance for Industry - VICH GL53 - Electronic Exchange of Documents: File Format Recommendations –
Draft Guidance for Industry - VICH GL53 - Electronic Exchange of Documents: File Format Recommendations – http://www.fda.gov/downloads/
Wednesday, August 27, 2014
Agenda for State of New Jersey Meeting August 27 2014
Board of Pharmacy - State of New Jersey
15 hours ago - BOARD OF PHARMACY. OPEN SESSION AGENDA. MONMOUTH CONFERENCE ROOM, 7TH FLOOR. August 27, 2014. I. CALL TO ORDER. II. SUNSHINE ...
www.nj.gov/lps/ca/pharm/agenda/pharage_082714.pdf
PhRMA jumps into Integrilin off-label case, free-speech arguments at the ready
It was inevitable. When a U.S. circuit court decided protected a pharma sales rep from off-label marketing charges, the free-speech arguments had to multiply. And they have, in cases across the country, testing that Second Circuit decision in other regions.
The latest: jumped into a California False Claims Act (FCA) case, with a friend-of-the-court brief defending , and 's right to talk up unapproved uses of the clot-fighting drug .
It's a wisely chosen target: The case, filed by former sales rep Frank Solis, hinges on journal articles that the company allegedly distributed to doctors, along with letters summarizing the studies. copromoted with Millennium, and ($MRK) bought Schering in 2009.
http://www.fiercepharmamarketing.com/story/phrma-jumps-integrilin-label-case-free-speech-arguments-ready/2014-08-27?utm_medium=nl&utm_source=internal
The latest: jumped into a California False Claims Act (FCA) case, with a friend-of-the-court brief defending , and 's right to talk up unapproved uses of the clot-fighting drug .
It's a wisely chosen target: The case, filed by former sales rep Frank Solis, hinges on journal articles that the company allegedly distributed to doctors, along with letters summarizing the studies. copromoted with Millennium, and ($MRK) bought Schering in 2009.
http://www.fiercepharmamarketing.com/story/phrma-jumps-integrilin-label-case-free-speech-arguments-ready/2014-08-27?utm_medium=nl&utm_source=internal
Horse Doping: Jones: "Either we eliminate the problem, or the problem is going to eliminate us"
But given the network of state regulatory bodies, how would you envision The Jockey Club’s role working? And where would it get the authority to actually take punitive actions other than pulling a horse’s registration, for example?
“We need to strengthen the penalties for doping horses, for example, and then you need to give that job of enforcement to somebody like the [USADA]. If you have USADA in control of that under the larger umbrella of The Jockey Club, it would seem to me that you would have your best opportunity of doing this properly. But what’s happened in the horse industry is that there’s been too much wrist-slapping when rules are broken and not enough penalties applied for these broken rules.”
read more here
Question of the Day August 27, 2014 How many traditional compounding pharmacies (those not registered as outsourcing facilities with the FDA) are fully complying with 503(A)? Should PBMs or insurance companies be reimbursing for drugs that are not in compliance with 503(A)? Should the insurance companies and hte PBMs report those compounding pharmacies that are not in compliance with the 503(a)?
Agency Information Collection Activities; Submission Office Guidance for Industry on REgistration of Human Drug Compounding Outsourcing Facilities
Agency Information Collection Activities; Submission Office ...
fda.federalregisterwatch.com/.../FDA-agency-information-collection-acti...
15 hours ago - Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; ...A Mississippi woman accused of administering an unlicensed silicone buttocks injection to a patient who later died should be convicted of murder, prosecutors told jurors in a trial that commenced on Tuesday: syringes labled "veterinary use only"
JACKSON Miss. (Reuters) - A Mississippi woman accused of administering an unlicensed silicone buttocks injection to a patient who later died should be convicted of murder, prosecutors told jurors in a trial that commenced on Tuesday.
Tracey Lynn Garner, 54, faces a charge of depraved-heart murder in the 2012 death of Karima Gordon, 37, in a case prosecutors say stems from a desire to make money.
Garner faces a separate trial in the death of Marilyn Hale, an Alabama woman who authorities say died under similar circumstances two years earlier.
Prosecutors said in their opening statement that Garner performed the unlicensed injections in her home, with greed as a motive.
Angelina Barber, a friend who accompanied Gordon to receive her injection, testified that Gordon fell ill almost immediately after the procedure. She died a few days later.
Lee McDivitt, an investigator for the Mississippi Attorney General's Office, testified that he found a large bottle of silicone and syringes in Garner's home that were labeled "veterinary use only."
continue to read here
Garner faces a separate trial in the death of Marilyn Hale, an Alabama woman who authorities say died under similar circumstances two years earlier.
Prosecutors said in their opening statement that Garner performed the unlicensed injections in her home, with greed as a motive.
Angelina Barber, a friend who accompanied Gordon to receive her injection, testified that Gordon fell ill almost immediately after the procedure. She died a few days later.
Lee McDivitt, an investigator for the Mississippi Attorney General's Office, testified that he found a large bottle of silicone and syringes in Garner's home that were labeled "veterinary use only."
continue to read here
Tuesday, August 26, 2014
Look at all the states including Texas and Oklahoma where Mesa Pharmacy/PAWs has recently been licensed
Now in 12 states and counting.
Mesa Pharmacy obtained licenses in many new states:
Texas (Issued: 8/19/2014)
http://www.tsbp.state.tx.us/dbsearch/phy_zoom.asp?id=29457
Nevada (Issued: 7/29/2014)
https://pharmacy.bop.nv.gov/datamart/details.do?anchor=92c508a.0.3
Indiana (Issued: 8/18/14)
https://mylicense.in.gov/EVerification/Details.aspx?agency_id=1&license_id=2087022&;
New Mexico (PENDING)
http://verification.rld.state.nm.us/Details.aspx?agency_id=1&license_id=920698
California (Issued: 10/4/2011)
http://www2.dca.ca.gov/pls/wllpub/WLLQRYNA$LCEV2.QueryView?P_LICENSE_NUMBER=50766&P_LTE_ID=774
Wisconsin (Issued: 5/9/2014)
https://app.wi.gov/LicenseSearch/OrganizationLicense/SearchResultsSummary?chid=946544
Illinois (Issued: 5/2/2014)
https://ilesonline.idfpr.illinois.gov/Lookup/LicenseLookup.aspx
Arizona
Y005936 Mesa Pharmacy VII 05/21/2014 10/31/2014 OPEN
Hawaii (Issued: 8/1/2011)
https://pvl.ehawaii.gov/pvlsearch/info/PMP-705-0
New Jersey (Pending)
https://newjersey.mylicense.com/verification/Details.aspx?agency_id=1&license_id=1850862
Florida (Issued: 9/17/2013)
http://ww2.doh.state.fl.us/IRM00PRAES/PRASINDI.ASP?LicId=20096&ProfNBR=2205
Oklahoma (Issued: 7/10/2014)
http://lv.pharmacy.state.ok.us/osbpinquire/PhrmcyDetail.asp?CountyAndLic=99-6802
quoted from here
Pharmacy Compounding Advisory Committee Charter date Extended
PDF]
[Docket No. FDA-2014-N-0001] Advisory Committee R
21 hours ago - Pharmacy Compounding Advisory Committee. Anesthetic and ... Committee. Science Advisory Board to the National ... Science Board to the Food and Drug.
[Docket No. FDA-2014-N-0001] Advisory Committee R
www.ofr.gov/(S(uhezl3vm2kbtsde3v0wl1f4b))/.../2014-20017_PI.pdf
Review; Comment Request; Guidance for Industry on Registration of Human Drug. Compounding Outsourcing Facilities Under Section 503B of the Federal --some questions answered
[PDF]
4164-01-P DEPARTMENT OF HEALTH AND HUMAN ...
5 hours ago - Review; Comment Request; Guidance for Industry on Registration of Human Drug. Compounding Outsourcing Facilities Under Section 503B of the Federal ...
4164-01-P DEPARTMENT OF HEALTH AND HUMAN ...
www.ofr.gov/(S(zd45olqhepz2cdi2lt3fxeho))/.../2014-20276_PI.pdf
Monday, August 25, 2014
Question of the Day August 25, 2014 Could it be that some compounders devised a scheme once the rules changed regarding reimbursements for compounded medications providing reimbursement for not just the highest priced ingredient covered by insurance but all ingredients listed that were covered? This scheme included adding as many covered drugs into the compounded medication as possible to get the maximun profit without regard to medical need. How much has this cost U.S. taxpayers, insurance companies, etc.? What is the ripple effect it has had on other areas of health care?
Compounding Pharmacies Engaging in Profiteering With “Designer Medications”? Posted by Greg Web
http://charlottesville.legalexaminer.com/uncategorized/compounding-pharmacies-profit-from-designer-medications/
Judge Refuses to Suspend Licenses of Doctors Involved in Workers' Comp Scheme
A judge on Friday refused prosecutors’ attempts to suspend the licenses of physicians and chiropractors accused in a $106 million workers’ compensation insurance kickback scheme that was allegedly orchestrated by a major supporter of President Barack Obama and led to the death of a 5-month-old boy.
The 15 doctors -- including one from -- pharmacists and other medical professionals -- including one from -- are scheduled to be arraigned Sept. 12.
Prosecutors wanted to suspend the licenses of the doctors and chiropractors, but Superior Court Judge Thomas Goethals denied the motion. Prosecutors said they are concerned about how any effort by state officials to suspend the licenses while the defendants await trial could affect the criminal case.
continue to read here
The 15 doctors -- including one from -- pharmacists and other medical professionals -- including one from -- are scheduled to be arraigned Sept. 12.
Prosecutors wanted to suspend the licenses of the doctors and chiropractors, but Superior Court Judge Thomas Goethals denied the motion. Prosecutors said they are concerned about how any effort by state officials to suspend the licenses while the defendants await trial could affect the criminal case.
continue to read here
Important!! Calif. - Alleged Landmark Compound Scheme Cost Carriers $105 Million
Top Story: Monday, August 25, 2014
Kareem Ahmed, president and chief executive officer of Landmark Medical Management, received more than $105 million from workers’ compensation carriers through fraudulent bills for compounded transdermal creams, the District Attorney’s alleges. Ahmed, 45, formulated compound creams based on the… Read more
MUST READ! Lot of Details! MEDICAL BUSINESS OWNER, DOCTORS, AND PHARMACISTS TO BE ARRAIGNED FOR DEFRAUDING OVER $100 MILLION FROM INSURANCE COMPANIES IN TOXIC MEDICATION SCHEME
SANTA ANA - A medical business owner, Workers’ Compensation doctors, and pharmacists are scheduled to be arraigned on an indictment for defrauding over $100 million from insurance companies by mass producing, distributing, and prescribing an expensive, toxic medication. Three of the defendants are also charged with manslaughter after a baby boy died as a result of exposure to the toxic cream.
The District Attorney (OCDA) took the case to the Orange County Grand Jury, which indicted the defendants on June 17, 2014. The defendants are scheduled to be arraigned today, Aug. 22, 2014, at 9:00 a.m. in Department C-45, Central Justice Center, Santa Ana. The defendants face sentences ranging from probation up to 14 years in state prison if convicted.Defendant, Age, City, Occupation Charges Custody Status
1 Kareem Ahmed, 45, , business owner 1 felony count of conspiracy to commit insurance fraud, 4 felony counts of insurance fraud written claim, 1 felony count of involuntary 1 felony count of manslaughter by lawful act in unlawful manner, sentencing enhancements for aggravated white collar crime over $500,000 Released on $5 million bail
2 Eduardo Ernesto Anguizola, 63, Orange, doctor 2 felony counts of insurance fraud written claim, 1 felony count of false and fraudulent claim, sentencing enhancement for committing property damage over $1.3 million Released on $800,000 bail
3 Michael Edward Barri, 46, , chiropractor 1 felony count of rebates for patient referrals, 2 felony counts of insurance fraud written claim, 1 felony count of false and fraudulent claim Released on $400,000 bail
3 Michael Edward Barri, 46, , chiropractor 1 felony count of rebates for patient referrals, 2 felony counts of insurance fraud written claim, 1 felony count of false and fraudulent claim Released on $400,000 bail
continue to read here
August 24, 2014 Get Ready; Get Set…. DEA Publishes Final Rule Rescheduling HCPs: Affected Registrants Must Swallow a 45-Day Compliance Window
By Karla L. Palmer –
The U.S. (“”) published last Friday a Final Rule rescheduling hydrocodone combination products (“HCPs”) from Schedule III to Schedule II. We posted about the proposed rescheduling here (NPRM published February 27, 2014). There was little doubt that would up-schedule HCP’s, especially in light of HHS’s recommendation to do so. It is disappointing, however, that DEA did not heed the request of industry and provide for more time for the implementation of the heightened security and other requirements.
continue to read here
Sunday, August 24, 2014
Question of the DAy August 25, 2014 Why aren't more states filing these types of actions? Note Ketamine is a Schedule II controlled substance also known as a "date rape" drug. So why is it "medically necessary" in so many cases where topical compounded creams are prescribed?
A.G. Schneiderman Announces $100,000 Settlement With Pharmacy Owner For Overbilling Medicaid For Ketamine
Queens Pharmacy Overbilled Medicaid For Reimbursement For Larger Ketamine Dosages Than Those Used
Schneiderman: Settlement Holds Pharmacy Owner Accountable For Profiting At Taxpayers’ Expense
Schneiderman: Settlement Holds Pharmacy Owner Accountable For Profiting At Taxpayers’ Expense
- Attorney General Eric T. Schneiderman announced today a $100,000 settlement with Oleg Aronov, a co-owner of Comprehensive Pharmacy, Inc. for overbilling taxpayers relating to the dispensation of compounded medications containing the drug Ketamine. Until its closing in 2009, Comprehensive Pharmacy was an enrolled provider of health care services to New Yorkers covered by Medicaid. Through its investigation, the Attorney General’s Office discovered that Comprehensive Pharmacy had overbilled Medicaid for Ketamine.
“Medical professionals who overbill Medicaid rob the program of important resources, and deprive many New Yorkers of essential services. This settlement holds Mr. Aronov accountable for profiting at the expense of taxpayers,” said Attorney General Schneiderman. “My office will remain committed to returning any funds misspent through violations of the Medicaid program.”
In addition to providing medications in the form of a pill or as a liquid, many pharmacies supply medications to patients in the form of creams. These compounded medications are usually prepared on site by a pharmacist. With regard to compounded medications containing Ketamine, Medicaid rules and regulations dictate that a provider may only seek reimbursement for the amount of Ketamine actually used in the compounded medication. Comprehensive Pharmacy, despite these rules, billed Medicaid as if Ketamine was the entire weight of the compound, when it was not. Attorney General Schneiderman’s investigation revealed that Comprehensive Pharmacy had submitted to the program tens of thousands of dollars in erroneous claims for compounded medications containing Ketamine.
Through his settlement with the Attorney General’s Office, Aronov agrees to reimburse the State, and admits to submitting erroneous claims to Medicaid indicating Comprehensive Pharmacy had dispensed compounded medications containing more Ketamine than was actually present in the medications dispensed to Medicaid patients.
While Ketamine, a general anesthesia, has a number of legitimate uses, it is also abused and is known as a “date rape” drug because of its ability to induce a dissociative state. Ketamine is classified as a Schedule III controlled substance. The Attorney General’s investigation did not uncover any evidence that the compounded medications prepared and erroneously billed by Comprehensive Pharmacy were being used for any illegal or illicit purposes.”
The Attorney General’s investigation originated from a referral by the Office of the Medicaid Inspector General (OMIG). Attorney General Schneiderman would like to thank OMIG for its assistance in resolving this matter.
The case was handled by Deputy Regional Director Thomas O’Hanlon and Special Assistant Attorney General Samuel Yee, under the supervision of Assistant Deputy Attorney General Paul Mahoney and Special Deputy Attorney General Monica Hickey-Martin. The investigation was conducted by Senior Special Investigator Thomas Dowd, under the supervision of Chief Investigator Thaddeus Fischer, and by Special Auditor Investigator Olga Sunitsky, under the supervision of Supervising Special Auditor Emmanuel Archer and the Medicaid Fraud Control Unit’s Regional Chief Auditor Thomasina Piccolo-Smith.
A copy of today’s settlement can be found here: www.ag.ny.gov/pdfs/Oleg-2013.pdf
Critical Read!! One employer recently learned it had paid almost $400,000 for about 140 compound drug prescriptions!! Some pharmacies are now billing in excess of $10,000 per prescription for compound drugs, but a review of the recipe shows they are often using generic ingredients and/or ingredients not approved by the FDA for the conditions they are intended to treat. In addition, Compound Drugs – What Can You Do About Their Startling Rise?
While many plan sponsors are paying close attention to their specialty pharmacy costs, they may be unaware of the latest disturbing trend in the pharmacy landscape: the startling rise in the cost of compound drugs. Compound drugs are mixed at the pharmacy according to a recipe prescribed by a physician and, up until the last couple of years, typically cost less than $100 per prescription.
However, today, a new type of pharmacy – one devoted to compounding drugs – is springing up across the country. And with the surge of these new pharmacies, we’re seeing big increases in the billed charge of compound drugs, which are frequently for topical pain relief. Some pharmacies are now billing in excess of $10,000 per prescription for compound drugs, but a review of the recipe shows they are often using generic ingredients and/or ingredients not approved by the for the conditions they are intended to treat. In addition, the doesn’t monitor operations at compounding pharmacies to ensure safety and sterility of the products manufactured.
One employer recently learned it had paid almost $400,000 for about 140 compound drug prescriptions. The compound drugs were excluded from the pharmacy benefit manager’s (PBM) annual trend report, which caused the employer to question why the trend report didn’t reconcile with the PBM’s invoices. After adding in the compound drugs, the employer’s overall trend jumped from 11% to 18% for 2013.
PBMs apply varying degrees of review on compound drug claims, making these claims ripe for fraud, waste, and abuse, especially since it’s not illegal for a physician to hold up to 40% ownership interest in the compounding pharmacies to which they’re sending the prescriptions
continue to read here
However, today, a new type of pharmacy – one devoted to compounding drugs – is springing up across the country. And with the surge of these new pharmacies, we’re seeing big increases in the billed charge of compound drugs, which are frequently for topical pain relief. Some pharmacies are now billing in excess of $10,000 per prescription for compound drugs, but a review of the recipe shows they are often using generic ingredients and/or ingredients not approved by the for the conditions they are intended to treat. In addition, the doesn’t monitor operations at compounding pharmacies to ensure safety and sterility of the products manufactured.
One employer recently learned it had paid almost $400,000 for about 140 compound drug prescriptions. The compound drugs were excluded from the pharmacy benefit manager’s (PBM) annual trend report, which caused the employer to question why the trend report didn’t reconcile with the PBM’s invoices. After adding in the compound drugs, the employer’s overall trend jumped from 11% to 18% for 2013.
PBMs apply varying degrees of review on compound drug claims, making these claims ripe for fraud, waste, and abuse, especially since it’s not illegal for a physician to hold up to 40% ownership interest in the compounding pharmacies to which they’re sending the prescriptions
continue to read here
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