Category Archives: Industry News

INSIDE THIS ISSUE CMS News: Home Infusion Therapy (HIT) Administration Codes are now Available Drug Reimbursement Code Price Updates: We review the reimbursement HCPCS/CPT® Codes in our system Drugs/Devices: New Clinical and Billing Information Software Updates: How to Locate a Drug Monograph CODE UPDATES Large Price Changes: We identify and report on the codes with […]

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 […]

INSIDE THIS ISSUE Code Updates: Large Price Changes New HCPCS® Codes and Changed Code Descriptions are Now Effective Code Strength Description Changes for New HCPCS® Codes CMS News: CMS Final Ruling on Medicare Physician Schedule Now Effective Quarterly ASP (Average Sales Price) Pricing File Released Hospital OPPS (Outpatient Prospective Payment System) Update Drug Reimbursement Code […]

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 […]

New Drug Overview – emapalumab-lzsg (Gamifant®) On November 20, 2018, the U.S. Food and Drug Administration (FDA) approved emapalumab-lzsg (Gamifant®) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Primary HLH is an ultra-rare disease, […]

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 […]

FDA Approval: 11/2/18 Febrile neutropenia is a complication that can occur in cancer patients receiving chemotherapy. Normally, neutrophils (a type of white blood cell) protect against infections; however, chemotherapy treatments may cause a reduction in neutrophils to abnormal levels in cancer patients, known as neutropenia. When significant neutropenia occurs in the presence of a fever, […]

INSIDE THIS ISSUE Code Updates: Update -J-Code 1599 Addition of 12 active NDCs Update- Removal of minimum and maximum dosing for J1325 and J3285 Update- Revision of maximum dose for J2278  CMS News: Medicare Influenza Vaccine Pricing 2018-2019 Season NEW Influenza CPT® Code 90689 Effective January 1, 2019 NEW HCPCS® Codes and Changed Code Descriptions […]

New Drug Overview – levoleucovorin (Khapzory™) On October 19, 2018, the U.S. Food and Drug Administration (FDA) approved levoleucovorin (Khapzory™) for three indications. Rescue after high-dose methotrexate therapy in patients with osteosarcoma. Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination. The treatment of patients with metastatic colorectal cancer in […]