Last week, many pharmacy and healthcare industry organizations sent announcements that FDA granted a two-year exemption to small dispenses for complying with the Drug Supply Chain Security Act (“DSCSA”). However, many pharmacies still have questions whether the exemption applies to them and how it affects them.
To remind, the DSCSA was enacted in 2013 with
If you are following opioid litigation across the nation, you probably wouldn’t be surprised by another billion dollar settlement. But this latest case against Endo Health Solutions Inc. (Endo) is different. It is a criminal fine (not a settlement) with criminal forfeiture. The degree of culpability and burden of proof is very different from the
Earlier this year, a client reported a very smooth scam. Someone called the pharmacy and represented to be a California Board of Pharmacy inspector who was investigating an anonymous complaint against the pharmacy. The so-called “inspector” asked the pharmacy to provide its account number with Cardinal, which the pharmacy staff did. The scammer then contacted
Due to heightened reporting requirements and recent large settlements against wholesalers for failure to report suspicious orders, many pharmacies experience issues with their supply of controlled substances (“CS”). I have represented many pharmacies in petitioning wholesalers to increase the cap on CS supply or not to cut such a supply. Often, such pleas fall on
Back in 2020, I wrote a blog post on potential PBM audit issues and disciplinary actions based on purchasing diabetic test strips from unauthorized wholesalers. The problem is still prevalent. In fact, during these past few months, we have seen several manufacturers sending cease-and -desist letters to pharmacies demanding money for lost sales and threatening
It is not uncommon for pharmacies to apply manufacturer’s coupons to assist patients with high deductibles. But when applied incorrectly, the pharmacy may face recoupments, audits/investigations, and large settlements as recent cases illustrate.
The U.S. Attorney’s Office has recently reached a $3.5 million settlement with specialty pharmacy Advanced Care Scripts, Inc. (ACS), to resolve allegations
Since the inception of the 340b program, drug manufacturers have been attempting to curtail it to avoid offering discounts or to prevent double discounts (which occurs when a 340b drug is billed to a Medicaid program). This year, however, there were multiple coordinated attempts by manufacturers to exit the program. For example:
This month, President Trump signed an executive order mandating that certain drugs and medical supplies purchased by federal agencies are U.S.-manufactured. The objective of the order is to reduce our dependence on foreign manufacturers for “Essential Medicines, Medical Countermeasures, and Critical Inputs” to ensure sufficient and reliable long-term domestic production of these products. The order
Do you purchase test strips from suppliers authorized by manufacturers to distribute these products? If not, you may face significant chargebacks and contractual termination when PBMs audit your pharmacy’s test strips invoices.
Virtually all PBM require test strips to be purchased from the suppliers expressly authorized by manufacturers to distribute their products. Most PBM manuals
As prescription drug spending continues to increase, governments continue to scrutinize arrangements between pharmaceutical companies, healthcare providers, assistance programs, and patients. For example, recently, two non-profit foundations – Chronic Disease Fund, Inc. (“CDF”) and Patient Access Network Foundation (“PANF”) – have agreed to pay $2 million and $4 million, respectively, to resolve allegations that they