ACCC Summary of RO Model Highlights Key Considerations

On July 10, 2019, the Centers for Medicare & Medicaid Services (CMS) announced new details of a proposed bundled payment model for radiation oncology services (“RO Model”). As proposed, the model would make fundamental (but temporary) changes to the way that Medicare pays for radiation therapy in certain randomly chosen geographic areas. Under the proposed model, Medicare would pay providers a pre-determined, site-neutral bundled rate for most services provided in a 90-day episode of radiation therapy, rather than paying for each service individually. The proposed model would be mandatory for providers selected to participate and is intended to incentivize providers to deliver radiation therapy services more cost-effectively while maintaining or improving the quality of care delivered.

The Association of Community Cancer Centers has released a summary of the proposed RO Model, including potential implications for providers and manufacturers offering radiation therapy services and products. The summary covers top-of-mind consideration for this model, as proposed, and outlines questions for further analysis going forward as ACCC works with stakeholders to further evaluate the proposal.

Based on the proposed rule’s anticipated date of publication date in the Federal Register, comments on the proposal will be due September 16, 2019.

Administration Withdraws Proposed Drug Rebate Rule

CMS Releases Proposed Radiation Oncology Model Rule

On July 10, 2019, the Centers for Medicare and Medicaid Services (CMS) released its proposal for a new mandatory Medicare Payment Model – the Radiation Oncology Model (RO Model) that seeks to promote the inclusion of radiation oncology in the evolution of value-based care arrangements in cancer care.

This model would be conducted under the Center for Medicare and Medicaid Innovation (CMMI) at CMS, and is proposed as a four-year model, running from 2020 through 2024. The proposal seeks to include 17 cancer types in the RO Model that would make prospective episode-based payments to participants in a site-neutral manner. The RO Model would also be furnished to provide physicians the opportunity to participate in an Advanced Alternative Payment Model (APM) under the Quality Payment Program (QPP). Participation in the RO Model would be required based upon radiation therapy (RT) services furnished in randomly selected Core Based Statistical Areas (CBST).
More details on the proposed model if available from CMMI here.

The ACCC policy team is continuing to analyze the effect of this proposal across our entire membership. CMS is accepting comments from relevant stakeholders up to 60 days after the release of this proposed rule into the Federal Register.

Posted 7/10/2019

FDA Approves Selinexor for Multiple Myeloma

Information on Keytruda Dosing & Testing Requirements

FDA Approves Pembrolizumab for Metastatic SCLC

FDA Approves Biosimilar Trastuzumab-anns for All Approved Herceptin Indications

FDA Approves First-Line Pembrolizumab for Metastatic or Unresectable HNSCC

FDA Approves Lenalidomide in Combination for Follicular and Marginal Zone Lymphoma

FDA Approves Alpelisib for Metastatic Breast Cancer

FDA Approves Venetoclax Plus Obinutuzumab for CLL and SLL

FDA Approves Avelumab Plus Axitinib for Advanced RCC

On May 14, Pfizer Inc. announced that the FDA has approved avelumab (Bavencio) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). A Phase III study showed that the combination significantly lowered risk of disease progression or death by 31 percent and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib.

Read the Pfizer press release.

Posted 5/15/2019

FDA Approves Ramucirumab for HCC

On May 10, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib.

FDA Approves Pembrolizumab + Axitinib for Advanced Renal Cell Carcinoma

FDA Expands Pembrolizumab Indication to Include First-Line NSCLC Treatment

FDA Expands Palbociclib Use to Include Male Breast Cancer Patients

HCPCS Assigns J-Code and ASP for Imfinzi

Imfinzi (durvalumab) has been assigned a unique Healthcare Common Procedure Coding System (HCPCS) code and average sales price (ASP) by the Centers for Medicare & Medicaide Services (CMS). The following code can be used to identify Imfinzi when billing across settings of care:

• J9173: Injection, durvalumab, 10 mg (vial size 500mg/10 mL, billing unit 50 units, NDC 0310-4611-50)
• J9173: Injection, durvalumab, 10 mg (vial size 120mg/2.4 mL, billing unit 12 units, NDC 0310-4500-12)

• J9173: Inj., durvalumab, 10 mg (HCPCS code dosage 10MG, payment limit $73.778).

FDA Approves Atezolizumab for Small Cell Lung Cancer

FDA Approves Trastuzumab-qyyp as Biosimilar to Herceptin

FDA Approves Atezolizumab Plus Nab-paclitaxel for TNBC