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Pharmaceutical Manufacturers, Wholesalers, and Distributors: Prepare for High Stakes Opioid Litigation

Earlier this year, Attorney General Jeff Sessions announced the creation of a task force to pursue the makers and distributors of prescription opioids and his intention for the Justice Department to play a substantial role in supporting plaintiffs throughout the country in prescription opioids-based lawsuits. In addition to the Justice Department's vocal support of such legal action, numerous lawsuits, including class action lawsuits, have already been filed throughout the United...

Washington Independent Pharmacies: Are You Tired of PBMs Playing Games with Your MAC Reimbursements?

Several States throughout the United States have passed laws regarding Maximum Allowable Cost (MAC) pricing and the corresponding appeals process. Some States have enacted legislation that is more favorable to independent pharmacies, than other States. One excellent example of a "pro-pharmacy" MAC-appeal State is Washington. In Washington, PBMs are required to uphold a pharmacy's MAC appeal if: (1) the pharmacy has fewer than 15 retail locations within the State of Washington, and...

What Arkansas Pharmacies Need to Know About Their MAC Appeal Rights

Several States throughout the United States have passed laws regarding Maximum Allowable Cost (MAC) pricing and the corresponding appeals process. In addition to enacting favorable MAC laws, some States such as Arkansas have afforded their resident pharmacies additional protections under their business tort laws. Together, these important laws not only expose PBMs to administrative fines and sanctions for non-compliance, but also permit Arkansas pharmacies to pursue direct civil remedies against offending...

CMS Tactics Used to Exclude Providers: How One Physician Can Sink the Whole Group

While some may still question whether it is true that "one bad apple can spoil the bunch," when it comes to doctors, group practices, and Medicare, this well-known adage is true. Surprisingly, there are instances when a single doctor's conduct, can result in dire consequences for the practice's Medicare privileges. Under the regulations governing revocation of Medicare privileges, the Centers for Medicare and Medicaid Services (CMS) can revoke Medicare privileges...

The Impact of DIR Fees on 340B Relationships Between Contract Pharmacies and Covered Entities

The impact of Direct and Indirect Remuneration ("DIR") fees on the specialty pharmacy industry cannot be overstated and has been widely reported in White Papers and industry news reports. However, the impact of DIR fees on the 340B sector is only now being realized. In the first of a series of articles, Frier Levitt explores the basics of DIR Fees as applied to 340B. The 340B Drug Discount Program ("340B")...