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
Consequences of purchasing test strips from inappropriate sources
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
When applying manufacturer’s coupons could get a pharmacy in trouble
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
Manufacturers exiting 340b program
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:
- AstraZeneca will stop
Executive order on ensuring essential medicines are made in the U.S.
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
PBM audits of test strips purchases. Things to keep in mind: clawbacks and terminations.
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
Dangerous Waters of Drug Assistance Programs
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
Drug prices are still going up … despite Transparency Laws
A recent report released by California health officials revealed that drug prices are still on the rise – even despite California’s drug-price transparency laws aimed at curbing drug cost.
In 2017, California passed a drug-price transparency law that requires manufacturers to notify its customers at least 60 days in advance if they plan to increase
Florida passed a bill allowing drug importation
The Medicare Modernization Act (2003) allows states to enact their own drug importation laws. The Act specifies that such laws would only be valid if the federal government reviewed and approved a state’s proposal to import prescription drugs. Despite the length of time since the passage of the Act, no state has enacted such law
Accepting drugs on false identity – How a wholesaler got into trouble
In 2015, the owner and pharmacist-in-charge of Lane Pharmacy passed away. The Pharmacy, however, carried on as nothing had happened. Allegedly, the Pharmacy continued to operate without a pharmacist. This “unusual” Pharmacy operated until 2017, when the California Board of Pharmacy received a complaint that non-licensed individuals were dispensing medications. The Board investigation revealed that