PDA will represent Boots pharmacists, ruling says
The Pharmaceutical Journal-3 hours ago
The Pharmacists' Defence Association Union (PDAU) will now represent Boots' pharmacists in pay, hours and working conditions negotiations following a ruling
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Monday, August 20, 2018
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Opinion: Investors have misdiagnosed Amazon's push into the ...
MarketWatch-10 hours ago
A case in point: My firm spent a lot of time thinking about pharmacies when we were analyzing investments in McKesson and other drug distributors.
Sunday, August 19, 2018
"Of the 547 pharmacies with questionable billing for compounded topical
drugs, 154 were located in the New York, Houston, Detroit, and Los Angeles
metropolitan areas. These four metropolitan areas had the highest
numbers of pharmacies with questionable billing of any metropolitan areas
in the Nation.
The New York area had 81 pharmacies with questionable billing. Together,
these pharmacies billed $67.6 million for compounded topical drugs, which
is 21 percent of the total amount billed in the Nation. The majority of the
pharmacies (51 of 81) each billed for an extremely high number of
compounded topicals from a single prescriber.
The Houston area had 32 pharmacies with questionable billing. These
pharmacies accounted for two-thirds of the pharmacies in the area (32 of
48) that billed for compounded topicals. Many of the pharmacies with
questionable billing (23 of 32) billed for extremely high dollar amounts per
compounded topical drug.
The Detroit area had 22 pharmacies with questionable billing. This
represented almost half of the pharmacies (22 of 47) in the area that billed
for compounded topicals. Like Houston, many of the pharmacies billed for
extremely high prices. In fact, 18 Detroit-area pharmacies each billed more
than $934 per compounded topical, on average.
The Los Angeles area had 19 pharmacies with questionable billing. This
represented almost half of the pharmacies in the area that billed for
compounded topicals (19 of 45). Many of these pharmacies (17 of 19) billed
for a high number of beneficiaries who received identical compounded
topical drugs.
124 prescribers
associated with
these pharmacies
raise particular
concern
A total of 124 prescribers"
quoted from report found here
quoted from report found here
"More than 100 pharmacies greatly increased the total amount they billed for compounded topical drugs from 2015 to 2016 There were 110 pharmacies that greatly increased their billing for compounded topicals over the course of just 1 year. Each of these pharmacies increased their billing for these drugs by more than 483 percent from 2015 to 2016. Of note, 20 of these pharmacies increased their billing by more than 10,000 percent. An extreme increase in a pharmacy’s billing may indicate fraud and abuse, especially when the spike is related to a particular type of drug. This may indicate that the pharmacy is billing for drugs that are not medically necessary or never dispensed. "
quoted from report found here
"Examples of pharmacies that billed a high number of compounded topical drugs from a single prescriber A pharmacy in New York billed Part D for 5,342 compounded topicals—totaling $1.6 million—ordered by a single podiatrist in 2016. This pharmacy also billed for over 1,000 compounded topicals each from five other podiatrists. In total, the pharmacy billed Part D $6.4 million for compounded topicals in 2016. A different New York pharmacy billed Part D for 2,775 compounded topicals—totaling $1.3 million—ordered by a single podiatrist. This pharmacy also billed for over 1,400 compounded topicals each from two other podiatrists. Of particular concern, one of these podiatrists was also a top prescriber in the example above. In total, this pharmacy billed Part D $7.3 million for compounded topicals in 2016. "
quoted from report found here
"Examples of pharmacies that billed high dollar amounts per compounded topical drug A pharmacy in Florida billed $1,752 per compounded topical drug, on average. In total, it billed Part D $1.1 million for compounded topicals. This pharmacy’s top prescriber was a family medicine physician located over 180 miles away from the pharmacy. Raising additional concern, the pharmacy billed Part D for compounded topical drugs for beneficiaries in 25 different States. A Texas pharmacy billed $2,447 per compounded topical drug, on average. In total, this pharmacy billed Part D $1.1 million for compounded topicals. Three-quarters of this pharmacy’s compounded topical drugs were prescribed by the same neurologist, and the majority contained diclofenac sodium 3% gel. "
quoted from report found here
If you have not read this entire study, it is a must read:
Questionable Billing for Compounded Topical Drugs in Medicare Part D
WHY WE DID THIS STUDY
In 2016, OIG called attention to significant growth in spending for compounded drugs (customized medications tailored to meet the needs of individual patients). Specifically, OIG found that Medicare Part D spending for compounded drugs grew by 625 percent from 2006 to 2015 and spending for topical compounded drugs-such as creams, gels, and ointments to relieve pain-grew at an even faster pace.
At the same time, OIG has been involved in an increasing number of fraud cases related to compounded drugs-including topical drugs-in Medicare and other health insurance programs.
There are also safety and effectiveness concerns related to compounded drugs, which are not FDA-approved. The quality standards for compounded drugs are generally lower than for FDA-approved drugs, leading to increased risks such as production of products with the wrong potency.
HOW WE DID THIS STUDY
We analyzed Prescription Drug Event (PDE) records for compounded topical drugs from 2010 to 2016. With input from OIG investigators and CMS, we developed five measures to identify pharmacies with questionable billing for these drugs. We also identified prescribers associated with these pharmacies.
WHAT WE FOUND
Medicare Part D spending for compounded topical drugs was 24 times higher in 2016 than it was in 2010. This explosive growth raises concerns about fraud and abuse. About 550 pharmacies had questionable Part D billing for compounded topical drugs in 2016. These pharmacies warrant further scrutiny. They each billed extremely high amounts for at least one of five measures that OIG has developed as indicators of possible fraud, waste, or abuse. For example, many of these pharmacies billed for compounded topical drugs for a high proportion of their beneficiaries. More than one-quarter of these pharmacies were located in four metropolitan areas. In addition, 124 prescribers associated with pharmacies with questionable billing raise particular concern. Each of these prescribers ordered high amounts of compounded topical drugs dispensed by these pharmacies.
WHAT WE RECOMMEND
We recommend that the Centers for Medicare & Medicaid Services (CMS) clarify Part D policies for coverage of compounded topical drugs and use of utilization management tools. Specifically, CMS should clarify that sponsors-the private companies that provide the Part D benefit-have the option to cover compounded topical drugs through an exceptions process. CMS should also clarify that sponsors may apply utilization management tools to compounded topical drugs, even if individual ingredients would not be subject to such tools when dispensed individually. CMS should also conduct additional analysis on compounded topical drugs and conduct training for Part D sponsors on fraud schemes and safety concerns. Lastly, CMS should follow up on the pharmacies and prescribers identified in this review. CMS concurred with all four of our recommendations.
Copies can also be obtained by contacting the Office of Public Affairs at Public.Affairs@oig.hhs.gov.
Download the complete report
quoted from here with emphasis supplied,
DEA raids Bruceton Pharmacy
WV News-Aug 18, 2018
BRUCETON MILLS — Customers who use the Bruceton Pharmacy will have to look for another place to have prescriptions filled after the U.S. Drug Enforcement ..
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