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.

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 9 hours ago

@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.

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DODINY 17 hours ago

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

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)