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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
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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:
- 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?
- 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.
- 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
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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
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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
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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
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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
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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
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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
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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
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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