NCCN also recently released Updated NCCN Guidelines for Genetic/Familial Risk Assessment: Colorectal Cancer and Colorectal Cancer Screening, which clarify how to use genetic testing and screening to detect cancer in high-risk individuals at an earlier stage.
Read NCCN press release.
On Monday, July 29, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2020 Outpatient Prospective Payment System (OPPS) proposed rule and the CY 2020 Physician Fee Schedule (PFS) and Quality Payment Program proposed rule.
CMS states that the OPPS proposed rule puts forward price transparency requirements that will increase competition among all hospitals by requiring them to make pricing information publicly available.
According the agency, the policy changes included under the proposed 2020 PFS rule align with the administration's aims to reduce providers' paperwork burden, remove unnecessary reporting measures, and reward clinicians for time spent with patients.
The ACCC policy team is currently reviewing both proposed rules and will provide a more in-depth summary for ACCC members shortly.
To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the U.S. Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders.
The company agreed and is removing these products from the global market.
The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.
These products have the same BIOCELL textured surface (shell), which is a unique surface used only by Allergan.
A list of Allergan’s BIOCELL textured devices marketed in the U.S. that will be voluntarily recalled can be found here.
The FDA notes that the macro-textured implants, like the BIOCELL textured implants manufactured by Allergan, represent less than 5% of breast implants sold in the U.S.
Read the full FDA announcement, which includes recommendations for patients and providers.
On July 23, the U.S. Senate Finance Committee released a long-anticipated drug-pricing bill. The legislation, which is slated for mark up on Thursday, July 25, includes significant changes to drug-pricing policy in Medicare and Medicaid. As written, the bill calls for restructuring of the Part D benefit, imposing much-debated inflationary rebates in Medicare Parts B and D, and increasing the rebate cap in Medicaid.
New Structure for Part D
The bill restructures Part D, eliminating the donut hole and shifting manufacturer liability to the catastrophic phase. Beneficiaries would pay costs up to $415 deductible. After meeting their deductible, during an initial coverage phase, beneficiaries would pay 25% of drug costs and plans would cover 75%. The out-of-pocket spending cap for beneficiaries would be $3,100.
During the catastrophic phase, Medicare would pay 20% for brand drugs, plans would cover 60%, and drug makers would pay 20%. For generics, Medicare would pay 40% and plans would pay 60%. As written, the legislation calls for this new structure to be phased in starting in 2022, and be in full effect by 2024.
The drug-pricing bill includes the following changes to Part B:
Pfizer Inc. announced on July 23, the U.S. Food and Drug Administration (FDA) approval of Ruxience™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
Read the corporate press release.