Sunday, December 27, 2015

Drug List Limitations, Exclusions and Preauthorization Criteria www.bcbsnm.com/pdf/rx/rx_pa_criteria_medicaid_nm.pdf

]Drug List Limitations, Exclusions and Preauthorization Criteria

www.bcbsnm.com/pdf/rx/rx_pa_criteria_medicaid_nm.pdf
19 hours ago - Cosmetic, Investigational DrugsDrugs for International Travel,.Compounded Medications. Drug Preauthorization: Medications primarily acquired at retail  ...

Prescription Drug Program Billing Instruction - Health Care Authority www.hca.wa.gov › documents › guides 8 hours ago - What drugs, devices, and supplies are not covered? .................................................... ............ ... Compounded Prescriptions

Pharmacy Services - Blue Cross and Blue Shield of New Mexico www.bcbsnm.com › pdf › rx_pa_criteria... 17 hours ago - Compounded Medications. Drug Preauthorization: Medications primarily acquired at retail pharmacies that require

PDF]Pharmacy Services - Blue Cross and Blue Shield of New Mexico

www.bcbsnm.com › pdf › rx_pa_criteria...

Some Federal Courts of Appeal clearly think the volume of compounding matters and that it is reasonable for the FDA to use this as a means of deciding whether a compounder is in fact a manufacturer and that the district court didn't err in failing to instruct the jury on the state's definition of dispensing;

Previous post found here discussed the 10th Circuit Court of Appeals affirming Bader's conviction for importation from China of HGH.  The 10th Circuit decision can be read at http://caselaw.findlaw.com/us-10th-circuit/1607808.html The Tenth Circuit was clear:


As the Third Circuit noted:[W]e agree that the FDA's reliance on the apparent volume of compounding is a reasonable means of determining whether that pharmacy is compounding in the regular course of its business of dispensing or selling drugs or devices at retail.   Indeed, were we to adopt Wedgewood's view that the volume of compounding is irrelevant, much of the FDCA would become a nullity.   If a pharmacy could compound an unlimited quantity of drugs, supposedly in anticipation of individual prescriptions, then it could essentially act as a commercial drug manufacturer and totally circumvent the approval requirements of the FDCA.Wedgewood Vill. Pharmacy, Inc. v. United States, 421 F.3d 263, 274 (3d Cir.2005) (internal quotation marks omitted);  accord Food and Drug, supra, § 13:74, at 13–95 (3d ed. 2007). - See more at: http://caselaw.findlaw.com/us-10th-circuit/1607808.html#sthash.9A95fOGS.dpuf

 A previous post found here discussed the district court's action in this case.  To review the indictment in this case, click here.  To review the district court's order in the case, click here.


Saturday, December 26, 2015

North Carolina Board of Pharmacy Rules Updated December 2015

CHAPTER 46 BOARD OF PHARMACY - North Carolina ...

www.ncbop.org/LawsRules/Rules.pdf
SECTION .0600 - DRUGS DISPENSED BY NURSE OR PHYSICIAN'S ASSISTANT..... compounding and distribution of drugs, the practice of pharmacy and

Second Question of the Day December 26, 2015 How many compounders are violating IACP's interpretation/answers in these FAQs on compounding dated August 2015?

The Case for Strict Statutory Construction of Mandatory ...


    The Case for Strict Statutory Construction of Mandatory ...

    scholarship.law.wm.edu/cgi/viewcontent.cgi?article=1486&context...
    by C Zaller - ‎2001 - ‎Cited by 17 - ‎Related articles
    carry out its laws by passing specific rules. ... legislation, Congress mandated judicial review of agency inaction ... from violating a mandatory statutory deadline unless theagency .... that the purpose of the bill was to give the courts a tool with which .... lethal injection, the Court had to compel more investigation before.

Law Review on Longstanding Agency Interpretations and the Precedential effect


Longstanding Agency Interpretations - Fordham Law Review

fordhamlawreview.org/.../Krishnakumar_March.p...
Fordham Law Review
by AS Krishnakumar - ‎Cited by 1 - ‎Related articles
agency statutory interpretations with the precedential effect that courts give .....passing, assigning no particular weight to it;7 (2) the court discusses the historical pedigree of ...

Question of the Day December 26, 2015 What is the effect of a subsequent Congress declaring what a previous Congress's intent in passing a law was? What would a federal court who is the interpreting body of laws passed by Congress say? Would they give any weight to such statements, ignore the statements or would it have harsh words for such action?


Thursday, December 24, 2015

Largest seizure of suspected counterfeit medicines by Hong Kong ... 7thSpace Interactive (press release)-10 hours ago Under the Pharmacy and Poisons Ordinance, any person who

Largest seizure of suspected counterfeit medicines by Hong Kong ...

7thSpace Interactive (press release)-10 hours ago
Under the Pharmacy and Poisons Ordinance, any person who

Seventh Circuit Rejects EEOC's Attack on Sevarance agreement

Seventh Circuit Reins In EEOC: Agency Cannot Bypass Conciliation ...

Mondaq News Alerts (registration)-9 hours ago
On December 17, the Seventh Circuit in U.S. Equal Employment Opportunity Commission v. CVS Pharmacy, Inc., No. 14-3653 (7th Cir. Dec. 17, 2015), rejected ...
Seventh Circuit Rejects EEOC's Attack on Severance Agreements
JD Supra (press release)-21 hours ago
Explore in depth (5 more articles)

US Senators: Let states allow partial opioid prescriptions Press Telegraph (blog)-8 hours ago They said "partial-fill" policies let patients work with their doctors and pharmacists to control pain while limiting the amount of unused

Senators seek clarification from DEA on opioids Lowell Sun-10 hours ago "These 'partial-fill' policies could empower patients to work with their doctor

Senators seek clarification from DEA on opioids

Lowell Sun-10 hours ago
"These 'partial-fill' policies could empower patients to work with their doctor

Conn. Collects $1.5 Million as Pharmaceutical Kickback Case Settles Connecticut Law Tribune-22 hours ago Between 2007 and 2012, it is alleged that Novartis paid kickbacks to three specialty pharmacies: BioScrip, Accredo and US Bioservices. These pharmacies were ...

How 2015 became the year of prescription drug price outrage Chicago Tribune-5 hours ago ... an agreement with Deerfield-based Walgreens, the nation's largest pharmacy retailer. The move would cut prices by 10 percent

Court: Top Iowa insurer must pay claims for life-saving drug Lexington Herald Leader

Court: Top Iowa insurer must pay claims for life-saving drug

Lexington Herald Leader-7 hours ago
Iowa's largest health insurer improperly refused to reimburse apharmacist for expensive life-saving drugs he dispensed to patients with a rare blood disease, ...

New York requires pharmacy benefit management contracts to ... Lexology (registration)-14 hours ago On Dec. 11, New York State Governor Andrew Cuomo signed Senate Bill 3346-B, requiring contracts between pharmacy benefit managers (PBMs

]2015 Industry Perspectives - Helios helioscomp.com/.../phm14-1510-01-industry-perspective--single.pdf?... 17 hours ago

]2015 Industry Perspectives - Helios

helioscomp.com/.../phm14-1510-01-industry-perspective--single.pdf?...
17 hours ago - (prescription drug usage specifically) for workers' compensation. WA .....Repackaged/compounded drugs are based on AWP of underlying drug product

Does the Federation of State Medical Board’s Interstate Licensing Compact Enhance Your Ability to Practice Medicine Across State Lines? By John E. Morrone, Esq., and Arielle T. Simkins, Esq.

Nuway Distributors llc Issues Voluntary [Worldwide/Nationwide] Recall of APEXXX Due to Presence of Undeclared Sildenafil 12/23/2015 03:54




Nuway Distributors llc is voluntarily recalling all lots of APEXXX tablets to the consumer level. FDA analysis found APEXXX to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug.

Injunction On 'Gray Market' Abbott Diabetes Test Strips Grows By Bonnie Eslinger


Law360, Los Angeles (December 23, 2015, 10:54 PM ET) -- A New York judge on Wednesday expanded a preliminary injunction barring pharmacies and distributors from selling international versions of Abbott Laboratories’ diabetes test strips domestically, rejecting some defendants' arguments that English-language versions of the product pose little confusion risk.

The decision from U.S. District Judge Carol Bagley follows on the heels of a similar order she granted last month preventing the “gray market” test strips from being sold while Abbott litigated its suit alleging Adelphia Supply USA and other companies imported FreeStyle glucose test strips intended...
To view the full article, register now.

PharmaHealth's Fairhaven office and pharmacy set to close SouthCoastToday.com-13 hours ago In February 2013, PharmaHealth was one of 11 compounding pharmacies ordered by the state to completely

Wednesday, December 23, 2015

Copy of Oklahoma State Board of Pharmacy Inspection form for Compounding Pharmacies

Effective January 1, 2016 in New Mexico

2016 - New Mexico Workers Compensation Administration

www.workerscom...
State of New Mexico Worker's Compensation Adminis...
7 days ago - medicine or dispense medical services. .... Compounded Medication . .....Any compounded medications dispensed and administered in excess of a twenty-

Must Read for Physicans/Doctors: Structuring Physician In-Office Drug Dispensing and Compounding Arrangements. Rick Hindmand, McDonald Hopkins LLC. Patrick Souter, Gray Reed .

 Structuring Physician In-Office Drug Dispensing and ...

https://www.healthlawyers.org/Events/Programs/.../u_hindman_souter.pd...
Structuring Physician In-Office Drug Dispensing and Compounding Arrangements. Rick Hindmand, McDonald Hopkins LLC. Patrick Souter, Gray Reed  .

FDA 483 09/01/2015 INCELL Corporation LLC 483 TX Outsourcing Facility 12/23/2015

Nuway Distributors llc Issues Voluntary [Worldwide/Nationwide] Recall of APEXXX Due to Presence of Undeclared Slidenafil 12/23/2015 03:54 PM EST Nuway Distributors llc is voluntarily recalling all lots of APEXXX tablets to the consumer level. FDA analysis found APEXXX to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug

Urgent: Drug Recall - Weight Loss Dietary Supplements with Undeclared Sibutramine and Phenolphthalein 12/23/2015 12:00 PM EST Under the brands: La' Trim Plus, Jenesis and Oasis, all lots and expiration dates.Recent Analysis by the Food and Drug Administration has found undeclared Sibutramine and Phenolphthalein in the Dietary Supplement "La'Trim Plus", "Oasis"

12/23/2015 12:00 PM EST

Under the brands: La' Trim Plus, Jenesis and Oasis, all lots and expiration dates.Recent Analysis by the Food and Drug Administration has found undeclared Sibutramine and Phenolphthalein in the Dietary Supplement "La'Trim Plus", "Oasis"

U.S. Attorney A. Lee Bentley III told Law360 in July that the Middle District of Florida is poised to recover $300 million this year and next year through FCA settlements as his office targets perpetrators of health care fraud. Retail pharmacies and compounding pharmacies in particular are getting hard looks, he said.

quoted from: http://www.law360.com/articles/731845/feds-expect-30m-from-fca-deals-with-fla-pharmacies

Second Circuit Tells Pharmacies The Antitrust Claims They Cooked ... Mondaq News Alerts (registration)-Dec 22, 2015 Cash & Henderson Drugs, Inc. v. Johnson & Johnson,1 recently decided by the Second Circuit, concerns Robinson-Patman Act2 claims that retail pharmacies

Second Circuit Tells Pharmacies The Antitrust Claims They Cooked ...

Mondaq News Alerts (registration)-Dec 22, 2015

Bipartisan House Coalition Emerges to Support Pharmacists' Role in ... Pharmacy Times-4 hours ago Arlington, Va. -

Bipartisan House Coalition Emerges to Support Pharmacists' Role in ...

Pharmacy Times-4 hours ago
Arlington, Va. - The National Association of Chain Drug Stores (NACDS) is lauding a letter to Secretary of Health and Human Services Sylvia Burwell from 44 .

Pharmacist's appeal a cause for real concern Mondaq News Alerts (registration)-10 hours ago The New South Wales Civil and Administrative Tribunal – Occupational Division recently dismissed an appeal by a Pharmacist to set aside an earlier order

Pharmacist's appeal a cause for real concern

Mondaq News Alerts (registration)-10 hours ago
The New South Wales Civil and Administrative Tribunal – Occupational Division recently dismissed an appeal by a Pharmacist to set aside an earlier order

Former Army Pharmacy Specialist Stole $2M in Drugs Patch.com-1 hour ago BETHESDA, MD — A

Former Army Pharmacy Specialist Stole $2M in Drugs

Patch.com-1 hour ago
BETHESDA, MD — A former U.S. Army pharmacy specialist who stole more than $2 million worth of a human growth hormone from Walter Reed Medical Center ...

America's addiction to painkillers has gotten so bad that people are now robbing pharmacy vans Quartz‎ - 3 hours ago More than 2 million Americans are addicted to prescription painkillers. Each day 7,000 people are treated in

New York Health Care Professional Sentenced To Prison; Another Pleads Guilty In Connection With Test-Referral Scheme With New Jersey Clinical Lab (indictment attached)

FOR IMMEDIATE RELEASE
Tuesday, December 22, 2015

New York Health Care Professional Sentenced To Prison; Another Pleads Guilty In Connection With Test-Referral Scheme With New Jersey Clinical Lab

NEWARK, N.J. – A physician’s assistant was sentenced to prison, and a doctor admitted taking bribes in connection with a long-running and elaborate test referral scheme operated by Biodiagnostic Laboratory Services LLC (BLS), of Parsippany, New Jersey, its president and numerous associates, U.S. Attorney Paul J. Fishman announced today.
Leonard Marchetta, 49, of Staten Island, New York, a physician’s assistant who previously pleaded guilty to one count of accepting bribes, was sentenced to 42 months in prison. Bret Ostrager, 50, of Woodbury, New York, a doctor with practices in Nassau County, New York, pleaded guilty to Count One, Count Two and Count Five of an indictment charging him with conspiracy to violate the Anti-Kickback Statute and the Federal Travel Act by accepting bribes, one substantive violation of the Anti-Kickback Statute, and one substantive violation of the Federal Travel Act. Both the sentencing and plea hearing took place today before U.S. District Judge Stanley R. Chesler in Newark federal court.             
Marchetta and Ostrager are two of the 39 people – 26 of them doctors – who have pleaded guilty in connection with the bribery scheme, which its organizers have admitted involved millions of dollars in bribes and resulted in more than $100 million in payments to BLS from Medicare and various private insurance companies. It is believed to be the largest number of medical professionals ever prosecuted in a bribery case. The investigation has to date recovered more than $12 million through forfeiture.
According to documents filed in this case and statements made in court:
Marchetta previously admitted that he accepted bribes in return for referring patient blood specimens to BLS and was paid approximately $3,000 per month. Marchetta’s referrals generated approximately $660,000 in lab business for BLS.

Bribery probe nets $12M and more than 2 dozen doctors Washington Post-17 hours ago

Bribery probe nets $12M and more than 2 dozen doctors

Washington Post-17 hours ago
Ostrager admitted getting monthly cash bribes of roughly $3,300 from lab employees and associates of Parsippany-based Biodiagnostic ...

An ongoing federal investigation of a New Jersey medical laboratory has netted guilty pleas from more than two dozen doctors, the latest ...
More news for bribery probe nets 12m

“The Pink Sheet” DAILY :: Pharma & Medtech Business ... https://www.pharmamedtechbi.com/publications/the-pink-sheet-daily 7 hours ago - Priority Review Vouchers, FDA Funding Win In Omnibus Budget Deal / FY 2016 funding bill is much higher than House and Senate appropriations

“The Pink Sheet” DAILY :: Pharma & Medtech Business ...

https://www.pharmamedtechbi.com/publications/the-pink-sheet-daily

Tennessee advances toward closed workers comp formulary Business Insurance-18 hours ago And the closed drug formulary would require prior authorization for “N” status drugs, such as fentanyl, compounded or topical

Combined Assessment Program Review of the Royal C ... www.va.gov/...

PDF]Combined Assessment Program Review of the Royal C ...

www.va.gov/.../VAOIG-15-04...
United States Department of Veterans Affairs
23 hours ago - drug spill kit was available in the compounding area and during transport of the medication to patient care areas. Hazardous CSPs were physically 

$2 Billion Research Boost a Major Milestone in 21st Century ... energycommerce.house.gov... House Committee on Energy and Commerce 7 days ago - H.R. 6, which included increased funding and important structural reforms, passed the ... boost for NIH and a $133 million increase for FDA for

$2 Billion Research Boost a Major Milestone in 21st Century ...

energycommerce.house.gov...
House Committee on Energy and Commerce
7 days ago - H.R. 6, which included increased funding and important structural reforms, passed the ... boost for NIH and a $133 million increase for FDA for 

The Food and Drug Administration will receive a total of $2.72 billion in discretionary funding in the bill.

FDA's Stellar Review Performance Is Straining Workforce / FDA is breaking records with approval numbers and review efficiency, but it comes with a cost workforce strain is pervasive

FDA's Stellar Review Performance Is Straining Workforce / FDA is breaking records with approval numbers and review efficiency, but it comes with a cost: workforce strain is pervasive, OND's Jenkins tells FDA/CMS Summit. / December 14 2015 11:00 PM / Read more

Shkreli's Indictment May Help Industry Escape His Shadow By Brenda Sandburg

Shkreli's Indictment May Help Industry Escape His Shadow


Executive Summary

Having a pharma CEO arrested usually wouldn't be good news for industry – except it’s this guy.


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