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Florida Legislature Introduces Bill Aimed at Regulating PBMs

In October 2017, the Florida legislature introduced HB 351, aimed at regulating pharmacy benefits managers – or "PBMs" – operating in the state. Up until this point, PBMs had operated in Florida without much direct oversight or regulation. If this Bill were to pass, several new requirements would become incumbent upon PBMs. Among other things, PBMs would be required to apply for registration with the Board of Pharmacy and adhere...

PBMs Continue to Increase Scrutiny of Mailing Operations

While PBMs have scrutinized retail pharmacies for mailing activities for some time, over the last several weeks, several major PBMs have embarked on renewed tactics aimed at clamping down on pharmacies dispensing prescription medications to their patients through the mail or other common carrier.  By way of example, certain PBMs (including Humana) have issued new waves of termination notices to pharmacies, alleging violations of contractual mail order limitations or improper...

NADAC Pricing and Aggressive PBM Prior Authorization Tactics: How Specialty Pharmacies Can Respond

Nearly every day, independent specialty pharmacies face industry changes that threaten their businesses. This year, two changes have been especially impacting – the implementation of the NADAC pricing benchmark and enhanced and aggressive prior authorization protocols and policies implemented by PBMs. Unfortunately, the implementation of the National Average Drug Acquisition Cost (NADAC) benchmark has been devastating to some pharmacies, which are often reimbursed at or below acquisition cost. Similarly, independent...

District Court Orders DHHS to Reevaluate Out-of-Network Payment Regulations Relating to In-Hospital Emergency Medical Services

Commercial payors are not the only entities that complicate the ability of out-of-network providers to be justly compensated for their services – the agencies that regulate such payors, and in particular the Department of Health and Human Services (DHHS), are often equally to blame, as they issue the regulations under which payors must operate and, often, manipulate to their advantage.  Out-of-network providers are not without recourse in this regard, however,...

Risk Evaluation Mitigation Strategies Spark False Claims Act Liability with Huge Impact

September 2017 marked the announcement of two multi-million dollar civil settlements against drug makers partially stemming from the respective companies' failure to comply with their promulgated Risk Evaluation Mitigation Strategies (REMS) which was a condition precedent for the Food and Drug Administration's (FDA) approval or their respective New Drug Applications. These settlements are noteworthy to any company with a drug subject to a REMS as well as to the pharmacies...