Author Archives: Todd Cooperman

In July 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 seven new products for review. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include […]

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

May 2018 Specialty Drug FDA Actions In May there were a total of five new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were eight supplemental drug approvals. The FDA had assigned eight new products for review and assigned five potential specialty products with June 2018 PDUFA dates. […]

INSIDE THIS ISSUE Code Updates:         • NDC Crosswalk update for HCPCS Code(s) J7050, J7040, and J7030         • NEW HCPCS Q-Codes effective July 1, 2018  Drug Reimbursement Code Price Updates  Drugs/Devices:         • New Clinical and Billing Information     CODE UPDATES Large Price Changes: We identify and report on the codes with the most substantial pricing increases or decreases […]

In April there were a total of five new drug approvals by the FDA we deemed specific to the specialty market. One of these approvals was a first-time generic approval for Zavesca®. In addition, there were six supplemental drug approvals. The FDA had assigned seven new products for review. Finally, there were six potential specialty […]

In March there were a total of seven drug approvals by the FDA we deemed specific to the specialty market.  In addition to these approvals, the FDA had assigned five new PDUFA dates. Finally, there were fifteen potential specialty products with PDUFA dates in April, although two of those products received a complete response letter […]

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 […]

2017 was a busy year for the Food and Drug Administration (FDA) with a 100 percent score in meeting the assigned (Prescription Drug User Fee Act) PDUFA dates for 46 products. Of these products 33% were first in class, 39% had an orphan designation, 85% were approved on the first review, and 78% were approved […]

INSIDE THIS ISSUE Code Updates:         • Large Price Changes         • New HCPCS C-Codes Effective April 1, 2018         • New HCPCS Q-Codes Effective April 1, 2018         • HCPCS Q-Code Description Change Effective April 1, 2018         • Deleted HCPCS Q-Code Effective April 1, 2018 CMS News:         • Part B Biosimilar Biological Product Payment Effective April 1, 2018         • Implementation of the Transitional Drug Add-On […]

INSIDE THIS ISSUE Webinar:         •  Solving for Incorrectly Mapped NDC to HCPCS/CPT® Codes And Improperly Reported NDC Units Blog Updates:         •  Hemlibra Introductory Pricing Drugs/Devices:         •  New/Updated Billing and Clinical Information Code Updates:         •  Large Price Changes         •  HCPCS/CPT Codes With Price Changes         •  Reminder – New HCPCS Drug Codes for 2018   WEBINAR Solving for Incorrectly Mapped NDC to HCPCS/CPT® […]