Oncology Newsfeed

CMS Releases Proposed 2020 OPPS and PFS Rules

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.

• Read the agency's press release on the proposed 2020 OPPS
• Read the agency's fact sheet on the proposed 2020 OPPS rule.
• Access the proposed OPPS rule. The rule is scheduled for publication in the August 9 Federal Register. The deadline for submitting comments on the proposed rule is September 27, 2019.

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.

• Read the agency's press release on the proposed 2020 PFS and Quality Payment Program (QPP) rule.
• Read the agency's fact sheet on the proposed 2020 PFS rule.
• Read the 2020 QPP Proposed Rule Fact Sheet.
• Access the proposed PFS and QPP rule. The proposed PFS rule is scheduled for publication in the August 14 Federal Register. The deadline for submitting comments on the proposed rule is September 27, 2019.

The ACCC policy team is currently reviewing both proposed rules and will provide a more in-depth summary for ACCC members shortly.

Posted 7/29/2019

FDA Requests Recall of Certain Textured Breast Implants

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.

Posted 7/24/2019

Senate Finance Committee Reveals Drug-Pricing Legislation

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.

Part B
The drug-pricing bill includes the following changes to Part B: 

• Establishes requirement that manufacturers pay rebates when drugs and biologicals prices increase faster than inflation, as measured by the CPI-U. (Biosimilars or vaccines paid under Part B are excluded from this measure.)
  
• Sets a new maximum add-on payment for drugs, biologics and biosimilars. 
  
• Increases payments for biosimilars to encourage their use over brand biologics.
  
• Requires drug, biologic and biosimilars makers to exclude the value of coupons provided to privately insured individuals when they report a drug’s ASP to HHS. However, the bill would not include contributions to patient assistance programs or foundations.
  
• Requires that patients be better informed about cost sharing.

FDA Approves Ruxience (rituximab-pvvr) for Adult NHL, CLL, Some Auto-Immune Conditions

ACS Launches Geriatric Surgery Verification Program

CMS Proposes CY 2020 & 2021 New Home Infusion Therapy Benefit

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