The People’s Pharmacy order by the
Board is an important one that will be difficult to meet at a level of rigor
that will protect patients—the order requires that policies be developed to
detect (implicating surveillance methods) and prevent errors in the dispensing
of compounded preparations (pharmacies little or no control over condition of
chemicals on receipt—ie moisture content, microbial bioburden). But even more
challenging, the order requires policies be developed to ensure the accuracy of
formulas used. The Board is zeroing in on a primary concern regarding the
foundation of the industry—thousands of untested recipes/formulas that may be
unsafe, ineffective, or missing important warnings/precautions for safe use. on
Texas Board of Pharmacy Disciplinary
Action for September 2013 -February 2014
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
Friday, August 29, 2014
Another Great Comment and Reminder From Reader Regarding Pre-printed Prescriptions
Pre-printed prescriptions were at
issue with respiratory (nubulizer) compounding decades ago, leading to
questionable reimbursements under Medicare Part B (the unapproved drugs may not
have been intended by prescribers, and, at the very least, the preprinted forms
did not include material facts about the products--seems they have resurfaced
here, particularly with respect to pain cream concoctions. Claims are made on
the benefit side, with little or no risk disclosure. on Question of the Day August 29, 2014
Should PBMs recoup claims and immediately terminate Network Proviider for all
claims relating to compounding pharmacies who have been using form/check the
box that were in violation of the Provider Manual? How much total money could
be recouped from this violation alone?
Check out this tip from a reader regarding prior matter involving precursors (butanediol) linked to Houston, Texas
Check out this prior matter
involving precursors (butanediol) with links to Houston, TX Genapharm:
http://www.fda.gov/downloads/ICECI/.../UCM091464.pdf on Texas man gets 20 years in synthetic
drug deaths - FOX 26 News | MyFoxHouston
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PBM Audit Lawyers: DEA’s Rescheduling of Compounds Containing Hydroco...
PBM Audit Lawyers: DEA’s Rescheduling of Compounds Containing Hydroco...: By Jonathan E. Levitt, Esq. and Benjamin J. Hochberg, Esq. On August 22, 2014, the United States Drug Enforcement Administratio...
2 From Calif. Accused In $105M Fraud Case
By Anthony Clark Carpio, Huntington Beach Independent, Calif. | |
McClatchy-Tribune Information Services |
continue to read here
Question of the Day August 29, 2014 Should PBMs recoup claims and immediately terminate Network Proviider for all claims relating to compounding pharmacies who have been using form/check the box that were in violation of the Provider Manual? How much total money could be recouped from this violation alone?
Very Important!! Georgia Pharmacy Association Audit Alert Regarding Pre-Printed Prescriptions and Express Scripts' Provider Manual
Audit alert: Pre-printed presciptions
20Aug
By Andrew Kantor
We have received information about a recent audit recoupment of a pre-printed, compounded prescription. Please be aware that language in the Express Scripts’ Provider Manual regarding pre-printed prescriptions is in Section 2.10 and reads as follows:
Network Providers may not produce, distribute, or accept pre-printed or pre-populated prescriptions for Covered Medications that include a controlled substance. This prohibition includes “check the box” order forms. Network Provider acknowledges and agrees that using, accepting,and/or distributing pre-printed or pre-populated prescription forms that include controlled substances constitutes a violation of law, including but not limited to, the Controlled Substances Act and its implementing regulations. PBM may, in its sole discretion, recoup claims and immediately terminate Network Provider for violating this section of the Provider Manual.
OIG Releases Special Fraud Alert: Laboratory Payments to Referring Physicians
Many physicians and other healthcare providers refer a high volume of patient specimens to third party clinical laboratories every day. The Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services recently issued a Special Fraud Alert that addresses these relationship between labs and physicians.
The OIG’s Alert focuses on laboratories that may be violating the Federal Anti-Kickback Statute (AKS) in an effort to win business from referring physicians. OIG’s chief concern is that physicians will do business with the lab that pays the most, rather than the best lab, and that physicians will order tests that are not medically necessary, particularly if the payment arrangement is tied to the number of referred tests.
The OIG focused on two types of arrangements that they fear pose a substantial risk of fraud and abuse, including (1) specimen collection and processing, and (2) registry arrangements.
- See more at: http://www.policymed.com/#sthash.cn520PJ4.dpuf
The OIG’s Alert focuses on laboratories that may be violating the Federal Anti-Kickback Statute (AKS) in an effort to win business from referring physicians. OIG’s chief concern is that physicians will do business with the lab that pays the most, rather than the best lab, and that physicians will order tests that are not medically necessary, particularly if the payment arrangement is tied to the number of referred tests.
The OIG focused on two types of arrangements that they fear pose a substantial risk of fraud and abuse, including (1) specimen collection and processing, and (2) registry arrangements.
- See more at: http://www.policymed.com/#sthash.cn520PJ4.dpuf
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