Author Archives: Todd Cooperman

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 […]

INSIDE THIS ISSUE Code Updates: Large Price Changes New HCPCS® Codes and Changed Code Descriptions Effective January 1, 2019 CMS News: CMS Final Ruling on Medicare Physician Schedule Effective January 1, 2019 Drug Reimbursement Code Price Updates: 47 Drug Codes required a recalculation of their AWP Code Price Drugs/Devices: New Clinical and Billing Information CODE UPDATES Large […]

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

In October there were a total of seven new drug approvals by the FDA we deemed specific to the specialty market. One of these approvals was for a biosimilar of Humira, which due to patents, is not slated to be launched until 2023. In addition, there were five supplemental drug approvals, two of which were […]

In September there were a total of six new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were two supplemental drug approvals. The FDA had assigned six new products for review. Finally, there was one complete response letter with no current data on expected resubmission date. Drugs included […]

INSIDE THIS ISSUE Code Updates: Large Price Changes New Q-Codes Effective October 1, 2018 New C-Codes for Hospital OPPS use Effective October 1, 2018 CMS News: Medicare Influenza Vaccine Pricing 2018-2019 Season NEW Influenza CPT® Code 90689 Effective January 1, 2019 Medicare Coverage Indicator Change for Q9994 Drug Reimbursement Code Price Updates Drugs/Devices: New Clinical […]

RJ identified a total of seven new FDA drug approvals specific to the specialty market in August 2018, and six supplemental drug approvals. The FDA had assigned four new products for review. Review the August 2018 RJ Health monthly specialty FDA actions newsletter below for more information. Drugs included in this review are generally regarded […]

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 […]