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  • FDA Approves Pembrolizumab for PD-L1 Positive Advanced SCC of Esophagus

    On July 31, Merck announced U.S. Food and Drug Administration (FDA) approval for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

    Read the corporate press release

    Posted 7/31/2019

  • FDA Approves Darolutamide for Non-metastatic Castration-resistant Prostate Cancer

    On July 30, Bayer announced U.S. Food and Drug Administration (FDA) approval of Nubeqa® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Nubeqa was approved under the FDA's Priority Review designation.

    Read corporate press release.

    Posted 7/31/2019

  • 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.

    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.

    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.
    The Senate is not slated to vote on the legislation until September.

    Concurrently, the House is working on its own drug-pricing legislation that is due for release in September. ACCC's policy team will be following developments on Capitol Hill closely and providing updates to its membership.

    Source: Inside Health Policy
    Posted 07/24/2019

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

    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.

    Posted 7/24/2019

  • ACS Launches Geriatric Surgery Verification Program

    On July 19, the American College of Surgeons (ACS) launched a new Geriatric Surgery Verification (GSV) Program at the ACS Quality and Safety Conference. The new surgical quality improvement program introduces 30 new surgical standards designed to systematically improve surgical care and outcomes for the aging adult population. Hospitals can implement to continuously optimize surgical care for this vulnerable population.

    Read the ACS press release here.

    Posted 7/22/2019

  • CMS Proposes CY 2020 & 2021 New Home Infusion Therapy Benefit

    On July 11, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule [CMS-1711-P] that provides for routine updates to the home health payment rates for calendar year (CY) 2020, in accordance with existing statutory and regulatory requirements. The rule includes proposals related to implementation of the permanent home infusion therapy benefit in 2021.

    The 21st Century Cures Act established the Medicare home infusion benefit, which will reimburse for nursing services, patient training and education, remote monitoring services and monitoring services for home infusion therapy treatments. The benefit enables home infusion of certain drugs including anti-infectives, chemotherapy, or treatment for immune deficiencies.

    The proposed rule would permit therapist assistants to provide maintenance therapy. The proposal includes proposed payment categories, amounts, and required and optional adjustments.

    Read CMS fact sheet.
    Access the proposed rule.

    Posted 7/18/2019

  • 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.

    Posted 7/16/2019

  • Administration Withdraws Proposed Drug Rebate Rule

    On July 11, the White House announced withdrawal of its proposed drug rebate rule that would have removed rebates from government drug plans. 

    “Based on careful analysis and thorough consideration, the President has decided to withdraw the rebate rule,” said White House spokesman Judd Deere. “The Trump administration is encouraged by continuing bipartisan conversations about legislation to reduce outrageous drug costs imposed on the American people, and President Trump will consider using any and all tools to ensure that prescription drug costs will continue to decline.”

    The controversial proposed rule fueled a rift in the Administration with HHS Secretary Alex Azar supporting the curbing of drug rebates and other White House officials in opposition due to the potential for the proposal to increase Medicare spending by nearly $200 billion.

    The proposed rule was considered central to the Administration's drug pricing reform plan. Withdrawal of the proposal likely signals an even greater focus by the Administration on its proposed International Pricing Index Model for Medicare Part B Drugs, which is currently undergoing review at the White House. 

    Posted 7/11/2019