NGS Alert for Pegfilgrastim Product Claims
This alert is for all hospital outpatient departments. Pegfilgrastim and biosimilars claims are denying in error due to an internal systems issue in Jurisdiction 6 and Jurisdiction K, Part A outpatient providers. National Government Services (NGS) is in the process of reviewing the cause of the errors and will determine the action it will take.
No provider action is necessary at this time, however, please continue to check the production alerts section of the NGS website and future email updates for additional information regarding this issue
If you have any questions, please contact NGS.
FDA Approves Daratumumab + Carfilzomib and Dexamethasone for R/R MM
On August 20, 2020 the U.S. Food and Drug Administration (FDA) approved Darzalex® (daratumumab) in combination with Kyprolis® (carfilzomib) and dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have received one to three previous lines of therapy.
Read Janssen's announcement.
Read the FDA announcement.
CMS Releases CY 2021 OPPS and PFS Proposed Rules
On August 4, 2020, the Centers for Medicare & Medicaid Reimbursement (CMS) issued the calendar year (CY) 2021 Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment Proposed Rule (CMS-1736-P). ACCC and council are reviewing these proposed rules and will be providing comments.
Until this analysis is complete, read the proposed OPPS rule and the proposed PFS rule. Then register for ACCC’s August 14 webcast on The 2021 Proposed PFS and OPPS Rules: Practical Implications and Considerations to gain insight into how these proposed rules will affect your cancer program.
FDA Approves Tafasitamab-cxix + Lenalidomide for R/R DLBCL
On July 31, 2020 MorphoSys and Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
Read corporate press release.
Read FDA announcement.
FDA Approves Keytruda for Patients with Unresectable or Metastatic MSI-H or dMMR CRC
On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
MSI-H/dMMR testing is required prior to initiating treatment with Keytruda in these patients. For the MSI-H/dMMR indication, select patients for treatment with Keytruda as a single agent based on MSI-H/dMMR status in tumor specimens. An FDA-approved test for the detection of MSI-H or dMMR is not currently available.
Read prescribing information and medication guide.
FDA Approves Pembrolizumab for Patients with Recurrent or Metastatic cSCC
On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co.) injection 100 mg for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Read FDA announcement and prescribing information.
FDA Approves Phesgo™ Injection for Subcutaneous Use
On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo, Genentech) injection, for subcutaneous use.
Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is indicated for use in combination with chemotherapy for:
Phesgo™ is indicated for use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Read corporate announcement.
Billing and coding sheet.
Update: COVID-19 Emergency Food Assistance Grant Amount Change
Due to increasing demand for the program’s financial assistance, the individual grant award amount has been changed to $300 effective immediately. This adjustment will allow thousands of additional patients to receive meaningful financial support for nutritional needs while maximizing the reach of available funding as the number of people impacting by COVID 19 continues to accelerate.
To date, the COVID-19 Emergency Food Assistance Program has helped more than 13,000 patients, including 1,000 emergency food deliveries made and over 12,000 financial assistance grants being provided to patients in all 50 states.
This innovative program is a collaboration between Team Rubicon (TR) and Patient Advocate Foundation (PAF) and provides emergency food delivery and financial assistance to people living with cancer, multiple sclerosis, and rheumatoid arthritis.
Who is Eligible?
Patients with cancer, multiple sclerosis or rheumatoid arthritis who have trouble accessing or affording food or other nutritional needs due to COVID-19, with eligibility established at the point of application in most cases.
For more information, including application instructions, click here.
FDA Approves Avelumab for Maintenance Treatment in Advanced Urothelial Carcinoma
On June 30, 2020, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio, EMD Serono, Inc.) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
Read FDA announcement.
FDA Approves Pembrolizumab for First-line Treatment of Metastatic MSI-H or dMMR CRC
On June 29, 2020, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
Read FDA announcement.