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  • FDA Approves New Treatment Option for CLL Under International Collaboration

    Nov. 21, 2019, the U.S. Food and Drug Administration (FDA) -  as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada - granted supplemental approval to acalabrutinib (Calquence ) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This new approved indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.

    Read FDA announcement.

    Read AstraZeneca corporate press release.

    Posted 11/21/2019
    Re-posted 11/26/2019


  • CMS Plans Dec. 3 Call on Hospital Price Transparency Final Rule

    The Centers for Medicare & Medicaid Services (CMS) Medicare Learning Network is holding a call on the final Hospital Price Transparency Final Rule on Dec. 3, from 1:30 - 3:30 PM EST.

    Register here.

    During this call, learn about provisions in the final rule effective Jan.1, 2021, including:

    • Requirements for making public all standard charges for all items and services in a machine-readable format
    • Requirements for displaying shoppable services in a consumer-friendly manner
    • Monitoring and enforcement

    A question and answer session follows the presentation. CMS encourages participants  to review the fact sheet and final rule prior to the call.

    Posted: 11/21/2019



  • CMS Issues Rules on Price Transparency for Hospitals and Health Insurance Issuers

    On Nov. 15, the Centers for Medicare & Medicaid Services (CMS) issued two rules that aim to increase price transparency and increase competition among all hospitals, group health plans, and health insurance issuers in the individual and group markets. The agency finalized the calendar year (CY) 2020 Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Charges Public rule, and issued the Transparency in Coverage Proposed Rule. Both rules (final and proposed) require that pricing information be made publicly available.

    The final "Price Transparency Requirements for Hospitals to Make Standard Charges Public" rule will require hospitals to make their standard charges public in two ways starting in January 1, 2021:

    • Comprehensive Machine-Readable File: Hospitals will be required to make public all hospital standard charges (including the gross charges, payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient, and the minimum and maximum negotiated charges) for all items and services on the Internet in a single data file that can be read by other computer systems. The file must include additional information such as common billing or accounting codes used by the hospital (such as Healthcare Common Procedure Coding System (HCPCS) codes) and a description of the item or service to provide common elements for consumers to compare standard charges from hospital to hospital.
    • Display of Shoppable Services in a Consumer-Friendly Manner: Hospitals will be required to make public payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient for an item or service, and the minimum and maximum negotiated charges for 300 common "shoppable services" in a consumer-friendly way and update the information at least annually.

    CMS fact sheet on final rule.
    Access final rule.

    CMS states that the proposed "Transparency in Coverage" rule is issued in response to an Executive Order dated June 24, 2019. The Department of Health and Human Services, the Department of Labor, and the Department of the Treasury are collectively issuing the proposed rule. As written, the rule would require that most employer-based group health plan and health insurance issuers provide up-front disclosure of price and cost-sharing information to participants, beneficiaries, and enrollees. 

    If finalized, the "Transparency in Coverage" proposed rule would require health plans to:

    • Provide consumers with real-time, personalized access to cost-sharing information, including an estimate of their cost-sharing liability for all covered healthcare items and services, through an online tool that most group health plans and health insurance issuers would be required to make available to all of their members, and in paper form, at the consumer’s request. This would allow consumers to shop and compare costs between specific providers before receiving care.

    Disclose on a public website their negotiated rates for in-network providers and allowed amounts paid for out-of-network providers. Making this information available to the public is intended to drive innovation, support informed, price-conscious decision-making, and promote competition in the healthcare industry.  

    Access a CMS fact sheet on the proposed rule.
    Access the proposed rule.

    More details are available in the HHS press release.

    Posted 11/15/2019


  • FDA Grants Accelerated Approval to Zanubrutinib for Mantle Cell Lymphoma

    On November 14, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa, BeiGene, Ltd.) for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

    FDA granted this application priority review and zanubrutinib received orphan product and breakthrough therapy designations for treatment of MCL. 

    Read FDA announcement.

    Posted 11/15/2019


  • ACP Issues New Guidance for Colorectal Cancer Screening

    On November 5, the American College of Physicians (ACP) published a new evidence-based guidance statement that supports colorectal cancer screening for average-risk adults between ages 50 and 75 who do not have symptoms. The new guidance was published in the Annals of Internal Medicine.


    The frequency of screening depends upon the screening approach selected, according to a statement from ACP, which suggests any of the following screening strategies:

    • Fecal immunochemical test (FIT) or high sensitivity guaiac-based fecal occult blood test (gFOBT) every two years
    • Colonoscopy every 10 years
    • Flexible sigmoidoscopy every 10 years plus FIT every two years

    Read the ACP press release.

    Posted 11/06/2019



  • FDA Office of Hematology Oncology Products, Now Called Office of Oncologic Diseases

    On November 5, the U.S. Food and Drug Administration (FDA) announced that the FDA's office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed as part of modernization plans approved in September 2019.

    The Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology Products (OHOP) has been reorganized and renamed the Office of Oncologic Diseases (OOD).

    Richard Pazdur, M.D., who joined the FDA in 1999 as director for the Division of Drug Oncology Products and became the OHOP Director in 2005, is the acting director of OOD.

    Read FDA press release.

    Posted 11/06/2019



  • FDA Approves Biosimilar Ziextenzo (pegfilgrastim-bmez)

    On Nov. 5, Sandoz, a Novartis division, announced U.S. Food and Drug Administration (FDA) approval of the company's biosimilar ZiextenzoTM (pegfilgrastim-bmez).

    Ziextenzo is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

    Read company press release.

    Posted 11/5/2019


  • CMS Issues RFI on Oncology Care First Model

    Late Friday, Nov. 1, the Center for Medicare and Medicaid Innovation (the Innovation Center) released an informal Request for Information (RFI), on value-based payment to support high-quality oncology care. In the Nov. 1 announcement the Innovation Center stated they hope to gather feedback during today's Public Listening Session that will outline a potential Oncology Care First (OCF) Model. 

    The Innovation Center stated Friday at the Nov. 4 Public Listening Session and in submitted written feedback, they hope to solicit stakeholder input on the following targeted topics:

    1. The potential OCF Model would seek to improve health outcomes and quality of care for Medicare beneficiaries with cancer. How could the potential model support participants’ care transformation through practice redesign activities? Specifically, how could the potential model build on lessons learned from the implementation of the practice redesign activities included in the Oncology Care Model (OCM)? What revisions or additions should be made to the OCM practice redesign activities in the potential model?
    2. We welcome feedback on the potential payment methodology, including the structure and design of the monthly population payment and the performance-based payment. We are considering the inclusion of additional services in the monthly population payment, such as imaging or lab services, and seek feedback on adding these or other services to the monthly population payment.
    3. We encourage feedback on the conceptualized risk arrangements, in particular, how a downside risk arrangement might be best constructed in terms of the level of risk.

    We invite feedback on the interest of physician group practices (PGPs) and hospital outpatient departments (HOPDs) in participating in a potential OCF Model. We are particularly interested in hearing from PGPs and HOPDs about the conceptualized participation eligibility parameters (e.g., the grouping concept), and whether they think that meeting those parameters would be feasible. We also invite feedback from potential payer partners, including commercial payers and state Medicaid agencies. We welcome suggestions about the model concept that would better incentivize participation in the potential model.

    CMMI Public Listening Session on Potential Oncology Payment Model
    Monday, Nov. 4, 2019
    1:00 to 4:00 PM
     EST

    Registration for the Public Listening Session is required. There are three ways to participate: in person, via livestream video, or via teleconference. REGISTER HERE.

    Posted 11/04/19


  • CMS to Hold Nov. 6 Call on PFS and OPPS Final Rules

    On Wednesday, November 6 from 2:15 p.m. to 3:45 PM, EST, the Centers for Medicare & Medicaid Services (CMS) through the CMS Medicare Learning Network is holding a call on provisions in the CMS CY 2020 final Outpatient Prospective Payment System and Physician Fee Schedule and Quality Payment Program final rules.

    Register Here.
    A question and answer session follows the presentation.

    Target Audience: Medicare Part B fee-for-service clinicians; office managers and administrators; state and national associations that represent health care providers; all hospitals operating in the United States; and other stakeholders. 

    Posted 11/04/19



  • CMS Releases CY 2020 Final Medicare Payment Rules

    On Friday, Nov. 1, the Centers for Medicare & Medicaid Services (CMS) released the final calendar year (CY) 2020 Hospital Outpatient Prospective Payment System (OPPS) rule (CMS-1717-FC) and the final CY 2020 Physician Fee Schedule (PFS) and Quality Payment Rule (CMS 1715-F).

    The CMS CY 2020 OPPS fact sheet states that:
    As finalized in last year’s rule, CMS is completing the two-year phase-in of the method to reduce unnecessary utilization in outpatient services by addressing payments for clinic visits furnished in the off-campus hospital outpatient setting.

    And further states:
    We acknowledge that the United States District Court for the District of Columbia vacated the volume control policy for CY 2019 and we are working to ensure affected 2019 claims for clinic visits are paid consistent with the court’s order.  We do not believe it is appropriate at this time to make a change to the second year of the two-year phase-in of the clinic visit policy. The government has appeal rights, and is still evaluating the rulings and considering, at the time of this writing, whether to appeal from the final judgment.

    340B Drug Pricing Program
    The CMS 2020 OPPS final rule fact sheet states that:
    For CY 2020, CMS is finalizing its proposal to continue to pay an adjusted amount of ASP minus 22.5 percent for separately payable drugs or biologicals that are acquired through the 340B Program. In the proposed rule, CMS acknowledged that the CY 2018 and 2019 OPPS payment policies for 340B-acquired drugs are the subject of ongoing litigation, and the agency is currently appealing the decision in the United States Court of Appeals for the District of Columbia Circuit. 

    Access full CMS Fact Sheet on the CY 2020 OPPS final rule.
    Access the CY 2020 OPPS final rule here.

    CY 2020 Physician Fee Schedule (PFS) and Quality Payment Rule
    The CMS fact sheet on the final CY 2020 PFS and Quality Payment rule states that:
    . . . we are aligning our E/M coding with changes adopted by the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel for office/outpatient E/M visits. The CPT coding changes retain 5 levels of coding for established patients, reduce the number of levels to 4 for office/outpatient E/M visits for new patients, and revise the code definitions. The CPT code changes also revise the times and medical decision making process for all of the codes, and requires performance of history and exam only as medically appropriate. The CPT code changes also allow clinicians to choose the E/M visit level based on either medical decision making or time.

    Physician Supervision Requirements for Physician Assistants
    In its 2020 PFS file rule fact sheet, the agency states:
    We are updating our regulation on physician supervision of PAs to give PAs greater flexibility to practice more broadly in the current health care system in accordance with state law and state scope of practice. In the absence of any state rules, CMS is finalizing a revision to the current supervision requirement to clarify that physician supervision is a process in which a PA has a working relationship with one or more physicians to supervise the delivery of their health care services. Such physician supervision is evidenced by documenting the PA’s scope of practice and indicating the working relationship(s) the PA has with the supervising physician(s) when furnishing professional services.

    Access the CMS 2020 PFS final rule fact sheet.
    Access the 2020 QPP Final Rule Fact Sheet 
    Access the CMS 2020 PFS final rule here.

    ACCC's policy team is analyzing these final rules and will provide more in-depth information to members soon.

    Posted 11/01/2019





  • FDA Approves Niraparib for HRD-positive Advanced Ovarian Cancer

    On October 23, 2019, the U.S. Food and Drug Administration (FDA) approved niraparib (Zejula, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy.

    The FDA also approved the Myriad myChoice CDx test for determination of tumor HRD status to select patients for niraparib.

    Read the FDA announcement.

    Access information on FDA-approved test for detection of deleterious or suspected deleterious BRCA mutation and/or genomic instability for this indication. 


    Posted 10/24/2019


  • Cosponsors for H.R. 3502 Surprise Billing Legislation Reach 102

    Congressional bipartisan legislation to address surprise medical billing (H.R. 3502) has received 102 cosponsors. The bill, Protecting People From Surprise Medical Bills Act was introduced Raul Ruiz, MD, (D-Calif.) and Phil Roe, MD, (R-Tenn.). The legislation would end the practice of unexpected healthcare bills by implementing independent dispute resolution. This process would require neutral arbitrated resolution on the billing cost between insurers and providers.

    Posted: 10/25/2019



  • Blood Cancer Patients Covered by Medicare Often Delay or Skip Treatment, Study Finds

    According to a new study from The Leukemia & Lymphoma Society (LLS), 59 percent of blood cancer patients enrolled in traditional Medicare do not start active treatment within three months of their diagnosis. While there are multiple reasons for delayed treatment starts or the decision to forego treatment, the study shows that patients receiving treatment for blood cancers may face the burden of high out-of-pocket costs.

    The study from Milliman, conducted on behalf of LLS, examines factors driving healthcare system costs and affecting patients. LLS released the study on Oct. 21.

    Read The Cost Burden of Blood Cancer in Medicare.

    Posted: 10/23/2019


  • NAM Issues Report on Systems Approach to Supporting Clinician Well-Being

    The National Academy of Medicine (NAM) has released a consensus study, Taking Action Against Clinician Burnout: A Systems Approach to Supporting Professional Well-Being, that is a call to action for healthcare organizations and educational institutions training health professionals, government, and industry to significantly improve clinical work and educational environments for all disciplines "to prevent and mitigate clinician burnout and foster professional well-being for the overall health of clinicians, patients, and the nation."

    The report sets out six goals and recommended system-wide actions to speed progress on burnout prevention and mitigation:

    1. Create positive work environments work that prevent and reduce burnout, foster professional well-being, and support quality care.
    2. Create positive learning environments that prevent and reduce burnout, foster professional well-being, and support quality care.
    3. Reduce administrative burden on clinicians that stem from a host of sources including legislation, policy, and an increasing requirements of accrediting and standard-setting entities.
    4. Optimize the use of technology to support clinicians in providing high-quality care.
    5. Provide support to clinicians and learners to alleviate symptoms of burnout.
    6. Invest in research on clinician professional well-being.

    Read the report recommendations.
    Read report highlights.
    Access the full report.

    Posted 10/23/2019


  • CMMI Plans Public Listening Session on Potential Future Oncology Payment Model

    The Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMMI) has announced a Public Listening Session on Potential Future Oncology Payment Model. Through the session CMMI seeks to gather feedback on value-based payment to support high-quality oncology care. According to the announcement, CMMI plans to release additional materials before the Nov. 4, 2019, Public Listening Session, and will announce when additional materials have been posted to the Innovation Center website.

    CMMI Public Listening Session on Potential Oncology Payment Model
    Monday, Nov. 4, 2019
    1:00 to 4:00 pm
    EST
    Hubert H. Humphrey Building (Great Hall)
    200 Independence Avenue,
    SW Washington, DC

    Registration for the Public Listening Session is required. There are three ways to participate: in person, via livestream video, or via teleconference.

    Posted 10/17/2019



  • ACCC Joins in Letter Urging CMS to Protect Timely to Advanced Diagnostics

    The Association of Community Cancer Centers together with the the Oncology Nursing Society, Friends of Cancer Research, the LUNGevity Foundation, and other oncology stakeholder organizations have joined in comments to the Centers for Medicare & Medicaid Services (CMS) regarding changes to the Laboratory Date of Service Policy (also known as the 14-day rule) included in the CY 2020 Hospital Outpatient Prospective Payment System proposed rule.

    The letter urges the agency not to finalize policy proposals that would reinstate barriers for Medicare beneficiaries that effectively limit or eliminate access to advanced diagnostics in a timely manner. 

    Read comment letter.

    Posted 10/10/19


  • Three Scientists Receive Nobel Prize in Medicine for Work on Cells and Oxygen

    On Monday, the Nobel Assembly announced the Nobel Prize in Physiology or Medicine would be jointly awarded to William G. Kaelin Jr., of the Dana-Farber Cancer Institute and Harvard University; Peter J. Ratcliffe of Oxford University and the Francis Crick Institute; and Gregg L. Semenza, of Johns Hopkins University. The three scientists are being honored for their work in revealing how cells manage responses to changes in oxygen levels. The results of their work have implications for treating a number of diseases, including cancer, anemia, heart attacks, and stroke.

    Posted 10/7/2019



  • ACCC Comments to CMS on Proposed 2020 OPPS & PFS Rules

    On Friday, September 27, the Association of Community Cancer Centers (ACCC) provided comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's proposed calendar year 2020 Outpatient Prospective Payment System (OPPS) and Physician Fee Schedule (PFS) rules. 

    CMS is expected to release the final CY 2020 Medicare payment rules in early November.

    Read ACCC's comments to the proposed CY 2020 OPPS rule.

    Read ACCC's comments to the proposed CY 2020 PFS rule.

    Posted 9/30/2019


  • FDA Approves Daratumumab in Combination for Frontline Multiple Myeloma

    On September 26, 2019, the U.S. Food and Drug Administration (FDA)  approved daratumumab (Darzalex, Janssen) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT).

    Read FDA announcement.

    Posted 9/26/2019


  • FDA Approves Non-Invasive CRC Screening Test for Eligible Individuals Ages 45 to 49

    Exact Sciences Corp. announced September 23 that the U.S. Food and Drug Administration (FDA) has approved the company's non-invasive colorectal cancer (CRC) screening test, Cologuard, for eligible average-risk individuals ages 45 and older, expanding on its previous indication for ages 50 and older.

    Read corporate press release.

    Posted 9/24/2019