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  • ACCC Comments to CMS on Proposed RO Model

    On September 16, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's proposed Radiation Oncology (RO) Model rule.

    In its comment letter, ACCC expresses committed support for the movement toward value-based care, noting that ACCC members have long been leaders in developing and participating in value-based payment systems.

    As CMS looks to finalize a model for radiation oncology, ACCC urges the agency to:
    • Make significant changes to the proposed episode payment methodology to ensure that the RO Model incentivizes innovation and cost-efficient care while allowing for equitable treatment of model participants.
    • Phase in mandatory participation in the RO Model to ensure equitable opportunity for success and ensure accurate and useful results from the model.
    • Delay the start of the RO Model until July 1, 2020 at a minimum.
    • Finalize the proposed exclusion of radiopharmaceuticals and certain brachytherapy surgical procedures from services covered by bundled payment.
    • Begin a new RT episode when a new course of treatment begins before a pending 90-day RT episode is complete.
    • Clarify certain aspects of the proposed quality reporting requirements.
    • Reconsider the uncompensated burden that would be required to comply with proposed monitoring and peer review requirements, which are not tied to pay for reporting.
    • Apply the 5 percent Advanced Alternative Payment Model (APM) incentive payment to the technical component of the RO Model payments as well as the professional component.
    • Structure the final RO Model so that all participants will be qualifying participants in an Advanced APM for purposes of the QPP, assuming minimum participation requirements are met.
    • Open the RO Model to voluntary participation by the Medicare Advantage plans and other payers.
    • Clarify how the RO Model will overlap with the Oncology Care Model (OCM) in a manner that allows for full and fair participation in both models.
    Read ACCC's comment letter.    

    Posted 9/23/2019

  • Pelosi Unveils Price Negotiation Bill, Similar to Draft Plan

    On Sept.19, House Speaker Nancy Pelosi introduced her much-anticipated government price negotiation plan that would empower the U.S. Department of Health and Human Services (HHS) to negotiate drug prices that would apply to all payers. A summary of the revised bill includes one major change from a draft plan (leaked on Sept. 9): the final version instructs HHS to negotiate prices on drugs without generic or biosimilar competition. Price negotiation would apply to drugs with no competition that are among the top 250 most costly drugs to Medicare and the U.S. health system. Under Pelosi's plan, the negotiated prices would be available to all payers, including commercial payers, and HHS would be required to negotiate a minimum of 25 drugs per year. (The earlier draft plan included price negotiation on drugs with less than two competing two competing generics or biosimilars.)

    Pelosi's plan also proposes a $2,000 out-of-pocket cap on prescription drugs for Medicare beneficiaries and disabled individuals. 

    The House Energy & Commerce Committee's Health Subcommittee is scheduled to hold a hearing on drug pricing legislation next week on Wednesday, Sept 25.

    Sources: InsideHealth Policy; NPR

    Posted: 9/19/2019

  • FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancers

    On September 17, 2019, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada, Janssen Biotech, Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer.

    Read FDA announcement.

    Posted 9/18/2019

  • With Project Orbis Collaboration, FDA Approves New Treatment for Endometrial Cancer

    On September 17, the U.S. Food and Drug Administration (FDA) announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE).  Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners.

    As part of Project Orbis, in conjunction with decisions by the Australian Therapeutic Goods Administration (TGA) and Health Canada, the FDA today granted accelerated approval to Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. Collaboration among international regulators through Project Orbis allowed for simultaneous decisions in all three countries.

    Read FDA announcement on Project Orbis.

    Read more on FDA approval of lenvatinib in combination with pembrolizumab for certain patients with advanced endometrial carcinoma.

    Posted 9/17/2019

  • FDA Consumer Information on Respiratory Illnesses Associated with Vaping Products

    The U.S. Food and Drug Administration (FDA) has announced new webpage on respiratory illnesses associated with use of vaping products.

    Both FDA and the U.S. Centers for Disease Control (CDC) are working to investigate incidents of severe respiratory illness associated with use of vaping products. 

    While federal and state health officials work to identify more information about the products used, where they were obtained and what substances they contain is ongoing, the FDA has some information that consumers can use to help protect themselves.

    Access the FDA information.

    Posted 9/13/2019

  • CMS Announces Support for Florida in Preparation for Hurricane Dorian

    The Centers for Medicare & Medicaid Services (CMS) Aug. 30 announced efforts underway to support Florida in response to Hurricane Dorian. Health and Human Services Secretary Alex Azar declared a public health emergency in the state. CMS is working to ensure hospitals and other facilities can continue operations and provide access to care despite the effects of Hurricane Dorian. CMS will be waiving certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements; creating special enrollment opportunities for individuals to access healthcare quickly; and taking steps to ensure dialysis patients obtain critical life-saving services.

    Below are key administrative actions CMS will be taking in response to the public health emergency declared in Florida:

    Waivers and Flexibilities for Hospitals and other Healthcare Facilities:  CMS will be temporarily waiving or modifying certain Medicare, Medicaid, and CHIP requirements. CMS will also issue a number of blanket waivers, listed on the website below, and the CMS Regional Office will grant other provider-specific requests for specific types of hospitals and other facilities in Florida. These waivers work to provide continued access to care for beneficiaries. More information is available here.

    Special Enrollment Opportunities for Hurricane Victims:  CMS will make available special enrollment periods for certain Medicare beneficiaries and individuals seeking health plans offered through the Federal Health Insurance Exchange. This gives people impacted by the hurricane the opportunity to change their Medicare health and prescription drug plans and gain access to health coverage on the Exchange if eligible for the special enrollment period. More information available here and here

    Disaster Preparedness Toolkit for State Medicaid Agencies:  CMS developed an inventory of Medicaid and CHIP flexibilities and authorities available to states in the event of a disaster. Access more information and the toolkit

    Dialysis Care:  CMS is helping patients obtain access to critical life-saving services. The Kidney Community Emergency Response (KCER) program has been activated ahead of the storm and is working with the End Stage Renal Disease (ESRD) Network of Florida, ESRD NW7, to assess the status of dialysis facilities in the potentially impacted areas related to generators, alternate water supplies, education and materials for patients, and more. They are also assisting patients who have evacuated ahead of the storm to receive dialysis services in the location to which they are evacuating. Patients have been educated to have an emergency supply kit on hand including important personal, medical, and insurance information; contact information for their facility, the ESRD NW hotline number, and contact information of those with whom they may stay or for out-of-state contacts in a water proof bag. They have also been instructed to have on hand supplies to follow a three-day emergency diet. The ESRD NW7 toll-free hotline is 800-826-3773 and the KCER hotline is 866-901-3773. Additional information is available on the KCER website

    Medical equipment and supplies replacements:  CMS will be temporarily suspending certain requirements necessary for Medicare beneficiaries who have lost or realized damage to their durable medical equipment, prosthetics, orthotics, and supplies as a result of the hurricane. This will help to make sure that beneficiaries can continue to access the needed medical equipment and supplies they rely on each day. Medicare beneficiaries can contact 1-800-MEDICARE (1-800-633-4227) for assistance.

    Suspension of Enforcement Activities:  CMS will suspend current survey and enforcement activities for healthcare facilities in Florida, but will continue to investigate allegations of immediate threat to patient health and safety.

    Ensuring Access to Care in Medicare Advantage and Part D:  During a public health emergency, Medicare Advantage Organizations and Part D Plan sponsors must take steps to maintain access to covered benefits for beneficiaries in affected areas. These steps include allowing Part A/B and supplemental Part C plan benefits to be furnished at specified non-contracted facilities and waiving, in full, requirements for gatekeeper referrals where applicable.

    Posted 8/30/2019

  • USPSTF Updates Recommendation on Screening, Counseling, Testing for BRCA-related Cancer

    The U.S. Preventive Services Task Force has updated its Recommendation Statement on BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing. The full recommendation is published online in the Aug. 20 issue of JAMA.

    The USPSTF recommends that primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with breast cancer susceptibility 1 and 2 (BRCA1/2) gene mutations with an appropriate brief familial risk assessment tool. Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated after counseling, genetic testing. 

    The USPSTF recommends against routine risk assessment, genetic counseling, or genetic testing for women whose personal or family history or ancestry is not associated with potentially harmful BRCA1/2 gene mutations. 

    Read the Recommendation Statement on the USPSTF website.

    Posted 8/20/2019

  • FDA Approves Fedratinib for Intermediate-2 or High-Risk Myelofibrosis

    On August 16, 2019, the Food and Drug Administration approved fedratinib (Inrebic, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).

    The prescribing information for fedratinib includes a Boxed Warning to advise healthcare professionals and patients about the risk of serious and fatal encephalopathy, including Wernicke’s encephalopathy. Healthcare professionals are advised to assess thiamine levels in all patients prior to starting fedratinib, periodically during treatment, and as clinically indicated. If encephalopathy is suspected, fedratinib should be immediately discontinued and parenteral thiamine initiated.

    Read FDA announcement.

    Posted 8/16/2019

  • FDA Approves Entrectinib for ROS1-Positive, Metastatic NSCLC

    Roche announced August 16 that the U.S. Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC).

    The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

    Read corporate press release.


  • FDA Grants Acalabrutinib (Calquence) Breakthrough Therapy Designation

    AstraZeneca announced August 14 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to acalabrutinib (Calquence) for chronic lymphocytic leukemia (CLL).

    The FDA granted the designation as a monotherapy treatment for adult patients with the disease, based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials, which will serve as the foundation for regulatory submissions later this year.

    FDA Breakthrough Therapy Designation is designed to accelerate the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results which may demonstrate substantial improvement on a clinically significant endpoint over currently available medicines. Use of acalabrutinib in adult patients with CLL is not yet FDA-approved.

    Read press release.

    Posted 8/15/2019

  • CMS Finalizes NCD for CAR T-Cell Therapy

    On August 7, the Centers for Medicare & Medicaid Services (CMS) released the finalized National Coverage Determination for FDA-approved Chimeric Antigen Receptor T-cell (CAR T-cell) Therapy. FDA-approved CAR T-cell therapies are approved to treat some people with specific types of cancer – certain types of non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia.  

    Medicare will cover CAR T-cell therapies when they are provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications (according to the FDA-approved label). In addition, Medicare will cover FDA-approved CAR T-cell therapies for off-label uses that are recommended by CMS-approved compendia.

    The NCD 
    continues coverage for routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1.

    In announcing the NCD, CMS notes that outcomes data for CAR T-cell therapy in the Medicare population are "relatively limited," and states that "CMS will leverage information obtained from the FDA’s required post-approval safety studies for CAR T-cell therapies to the fullest extent possible." 

    Read the CMS Decision Memo.

    Download CMS Decision Memo.

    Posted 8/07/2019

  • New NCCN Guidelines Address Small Intestine Cancers

    On August 1, the National Comprehensive Cancer Network (NCCN) announced release of new NCCN Guidelines for Small Bowel Adenocarcinoma. These are the first clinical guidelines in the U.S. to address this rare but growing cancer type, which is sometimes associated with hereditary causes like Lynch syndrome.

    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. 

    Posted 8/1/2019

  • HHS Issues Plan Outlining 2 Paths for Prescription Drug Importation

    The U.S. Department of Health and Human Services (HHS) announced today that HHS and the U.S. Food and Drug Administration (FDA) are publishing a Safe Importation Action Plan that outlines two potential pathways that would lay the foundation for the importation of certain drugs originally intended for foreign markets.

    Pathway 1: A Notice of Proposed Rulemaking (NPRM) would rely on the authority in the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) section 804 to authorize demonstration projects to allow importation of drugs from Canada.

    Pathway 2: Manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the U.S. versions. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require. 

    Read the HHS press release.
    Read the administration's Action Plan.

    Posted 7/31/2019

  • 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