Author Archives: Todd Cooperman

In May there were three new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were 14 supplemental drug approvals. The FDA had acted on assignment of three new product reviews, although no PDUFA dates were published. Drugs included in this review are generally regarded by the industry as […]

In April there were four new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were five supplemental drug approvals. The FDA had acted on assignment of new PDUFA dates for six new products for review. Drugs included in this review are generally regarded by the industry as specialty […]

In March there were three new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were four supplemental drug approvals. The FDA had acted on the assignment of new PDUFA dates for ten new products for review. Finally, there was one product that had an extension of a PDUFA […]

As drug spend increases, so does the use of genetic tests. How does this affect claims processing? Watch to learn more: VIEW THE FULL WEBINAR [TRANSCRIPT] So, the next question that we often hear from our clients is great, don’t need to worry about this on the pharmacy benefit, medical benefit, so what we did […]

INSIDE THIS ISSUE CMS News Drug Reimbursement Code Price Updates Drugs/Devices New Clinical and Billing Information Software Updates Prioritize your Code Level Pricing CODE UPDATES Large Price Changes: We identify and report on the codes with the most substantial pricing increases or decreases each month and detail the rationale for the change. Of the 35 […]

Of about clinical 1,400 studies, 34% were tied to some sort of genetic test. This will only increase over time. Watch to learn more: VIEW THE FULL WEBINAR   [TRANSCRIPT] Now, the other piece is, okay, great, so we have these 27 products, pretty small compared to the hundreds or thousands of products that we’re […]

Today there are 27 drugs that have been approved by the FDA that have genetic companion diagnostics tied to them. Genetic-defined therapies are becoming more prevalent in many cases. Although not the case with every therapy, there is definitely a trend with drugs requiring genetic tests having a higher cost per treatment. Watch to learn […]

In January there was one new drug approval by the FDA we deemed specific to the specialty market. In addition, there were three supplemental drug approvals. The FDA had acted on assignment of new PDUFA dates for three new products for review. Finally, there were two complete response letters issued and one manufacturer triggered withdrawal […]

Enacted in 1992, the Prescription Drug User Fee Act (PDUFA) was created to authorize the Food and Drug Administration (FDA) to collect fees from companies that produce certain human drug and biological products. These fees serve as a secondary source of funding for the FDA and serve to expedite the review process.  The FDA establishes […]

In December there were a total of four new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were six supplemental drug approvals. The FDA had assigned eight new products for review. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include […]