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.ONCOLOGY
CMS delays radiation oncology payment model until July
Becker's Hospital Review
CMS confirmed its radiation oncology payment model will not start until July in the 2021 Hospital Outpatient Prospective Payment Final Rule.
The agency said it received feedback from several stakeholders in October about the challenges of preparing to implement the new radiation oncology payment model by Jan. 1 and would delay the start date to July through upcoming rulemaking. In a Dec. 2 final rule, CMS said the model would start July 1.
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Impact of COVID-19 on oncologists
PharmExec.com
In response to the COVID-19 pandemic, U.S. oncologists have adjusted patient care by embracing telemedicine and switching more patients to oral therapies to limit office visits — but personally, more oncologists may be experiencing burnout due to the loss of face-to-face interactions with patients, according to new research from Cardinal Health Specialty Solutions.
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.GENOMICS
Genomics analysis moves to the next level
Genetic Engineering & Biotechnology News
Science fair projects presenting complicated genomic analyses. Smartphones displaying personal genome sequences. Treatment plans specifying genomic modifications. These are just a few of the “bold predictions” outlined in the new strategic vision developed by the National Human Genome Research Institute. These, in addition to the more attainable near-term goals, hinge on the fundamental technology of DNA sequencing.
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Discovery shines light on how cancer cells could protect themselves
Medical Xpress
Sydney researchers have found cancer cells can repair their DNA by using 'cables' in their nucelus. The findings open new possibilities for designing future cancer treatments.
Researchers at Children's Medical Research Institute in Westmead, Sydney, have made an unexpected discovery about cancer cells and how they harness 'cables' in a cell's nucleus to aid DNA repair and replication.
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.EMERGING MEDICAL TECHNOLOGIES
Developing novel non-invasive imaging techniques for cancer biomarkers
European Pharmaceutical Magazine
Preclinical imaging plays a crucial role in understanding how the body works in both healthy and diseased states, and in describing responses to physiological or environmental changes. It provides important insights into disease processes at organ, tissue, cell and molecular levels. Such knowledge informs the development of novel therapeutic strategies, which in turn improve patient outcomes and save lives.
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AI offers accurate prediction of chemotherapy effectiveness prior to breast cancer surgery
The Korea Bizwire
South Korean researchers have developed new technology that uses artificial intelligence to anticipate the effects of chemotherapy for breast cancer patients.
The Korea Institute of Radiological Medical Sciences announced recently that an AI deep learning mechanism can be used to anticipate the effects of chemotherapy for breast cancer patients before they begin treatment.
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.BIOTECH/DIAGNOSTICS/PERSONALIZED MEDICINE
Precision medicine highlights the importance of biomarkers in melanoma
Oncology Nursing News
With the identification of actionable alterations, precision medicine continues to lead the way in all areas of oncology, but especially in melanoma, according to Jason J. Luke, MD, FACP, who added that, in order to successfully apply personalized therapy, it’s critical to be fluent in the differences between biomarkers.
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At-home COVID-19 tests: Advancing do-it-yourself diagnostics
CBS News
The town of Bethlehem, Pennsylvania was famous for producing steel. But the smokestacks are relics. Now, a very different kind of industry is thriving in the Lehigh Valley.
"This company was actually founded in the shadows of the old Bethlehem Steel," said Stephen Tang, the CEO of OraSure Technologies, a biotech company that produces diagnostic tests you can do at home. As millions of Americans lost their jobs last spring, OraSure started hiring.
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.REGENERATIVE MEDICINE
Development of new stem cell type may lead to advances in regenerative medicine
Phys.org
A team led by UT Southwestern has derived a new "intermediate" embryonic stem cell type from multiple species that can contribute to chimeras and create precursors to sperm and eggs in a culture dish.
The findings, published online this week in Cell Stem Cell, could lead to a host of advances in basic biology, regenerative medicine, and reproductive technology.
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.MANAGED HEALTHCARE NEWS
Government, drug companies gearing up to distribute COVID-19 vaccine
Managed Healthcare Executive
With approval of the Pfizer-BioNTech COVID-19 happening as early as next week, attention is shifting how it and other COVID-19 vaccines will be distributed and administered.
Certainly pharmacists and possibly dentists and optometrists will be playing an important role in administering the COVID-19 vaccine.
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Could the pandemic put an end to medical overtreatment?
Managed Healthcare Executive
Several years ago, more than 2,000 physicians indicated in a survey that significant proportion of medical care is unnecessary and ineffectual. Responses to the survey suggests that more than a fifth of overall medical care is unnecessary as is more than a fifth of all prescribed medications.
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.FDA: NEW TREATMENTS AND TECHNOLOGY
FDA approves 1st PSMA-targeted PET imaging drug for men with prostate cancer
U.S. Food & Drug Administration
On Dec. 1, the U.S. Food and Drug Administration approved Gallium 68 PSMA-11 — the first drug for positron emission tomography imaging of prostate-specific membrane antigen positive lesions in men with prostate cancer.
Ga 68 PSMA-11 is indicated for patients with suspected prostate cancer metastasis who are potentially curable by surgery or radiation therapy.
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On the edge of a key COVID-19 decision: 5 questions answered
Bloomberg
The coming week could mark an early turning point in the U.S. battle against COVID-19. Advisers to the Food and Drug Administration are set to review the first vaccine and their guidance could speed authorization, clearing the way to making it a top weapon against the virus.
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.ACCOUNTABLE CARE ORGANIZATIONS
CMS announces a new value-based direct contracting model
RevCycleIntelligence
A new direct contracting model from CMS will test whether a geographic-based approach to value-based care can improve quality of care while reducing costs for Medicaid beneficiaries in a specific region.
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Medicaid MCO enrollment continued rising through September 2020
HealthPayerIntelligence
States may need to re-evaluate their Medicaid managed care organization payment rates as trends of increased enrollment and low care utilization continue into fiscal year 2021, according to a Kaiser Family Foundation data note.
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.NAMCP UPDATES
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| Biodesix, Inc., a leading data-driven diagnostic solutions company with a focus in lung disease, today announced publication of an analysis of the company’s Nodify XL2® lung nodule test. The test supports clinical decision-making for suspicious nodules by more accurately identifying patients with a very low risk of malignancy and shifting those patients into surveillance, thereby minimizing invasive procedures on those with benign nodules. Please click here to view the full press release.
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| LivaNova PLC, a market-leading medical technology and innovation company, today announced the publication of a new study in the International Journal of Bipolar Disorders that showed adding Vagus Nerve Stimulation Therapy (VNS Therapy®) to treatment as usual (TAU) significantly improves outcomes in patients with treatment-resistant bipolar depression (TRBD). The study examined patients from a five-year prospective registry and found 63% of TRBD patients treated with adjunctive VNS Therapy in addition to TAU had a significant reduction in depressive symptoms, as measured by a 50% or greater reduction in the Montgomery–Åsberg Depression Rating Scale (MADRS), compared with 39% of patients in the TAU alone group. Click here to view the entire press release. Click here to view the entire press release.
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| Additionally, LivaNova PLC announced a publication in Contemporary Clinical Trials, which details the design for “A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression” or the RECOVER clinical study. RECOVER is currently under way as part of a Coverage with Evidence Development framework of the U.S. Centers for Medicare & Medicaid Services’ (CMS) National Coverage Determination process. Click here to view the entire press release.
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| In late 2018, the National Association of Managed Care Physicians (NAMCP) decided to create the Value Based Care Council (VBCC). The VBCC mission supports empowering medical directors with information and resources to assist them in making value based decisions that support achieving the Triple AIM of improved outcomes and the patient experience while reducing overall costs. The goal is to improve the integration of cost, quality, and access in the clinical decision making process so as to enhance the effectiveness and efficiency of extracting value from the associated spend in order to optimize outcomes.
Pursuant to the above, and in response to an unmet need in the marketplace, the VBCC developed a short form in order to enhance the effectiveness and efficiency with which value propositions can be shared between industry and the medical leadership of various payers throughout the country. This same short form provides a concise and consistent manner with which value propositions can be shared and provides the ability to align expectations prior to actually conducting conversations or having a meeting regarding a product or service.
The Product Value Proposition Customer Engagement Short Form can be found on the NAMCP website (www.namcp.org) in the Value Based Care Council subsection of the Councils tab, under tools and resources. Please contact Will Williams at wwilliams@namcp.org with questions or for additional information.
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| Jazz Pharmaceuticals is excited to announce the approval of ZEPZELCA™ (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. ZEPZELCA is a second-line therapy that has been studied in both platinum-sensitive and -resistant SCLC patients. Please click here for more information.
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| Takeda Pharmaceuticals is part of, "The Fight Is In Us", an initiative to maximize the individual and societal benefit of COVID-19 plasma. The campaign will focus on recruiting COVID-19 survivors to donate their plasma at licensed blood and plasma donor centers.- If you’ve recovered from #COVID19, your immune system has antibodies that could be used as a treatment. See if you can help others by donating plasma www.TheFightIsInUs.org. #TheFightIsInUS
- The antibodies that helped you or someone you know fight off COVID-19 may be able to help others. Visit www.TheFightIsInUs.org to see if you qualify to donate plasma. #TheFightIsInUs
You are a survivor, now you could be a hero. Plasma from recovered #COVID19 patients could play a key role in creating a potential therapy for coronavirus. Learn how you can donate at www.TheFightIsInUs.org #TheFightIsInUs
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| Biodesix, Inc., a leading diagnostic company in lung disease, recently announced a partnership with Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) to bring a COVID-19 Droplet Digital PCR (ddPCR) test to the FDA for an Emergency Use Authorization (EUA) approval to support the escalating need for testing in the U.S. Two studies published this month, ahead of peer review, reported that ddPCR testing showed superior sensitivity and precision for clinical detection of SARS-CoV-2 (the virus that causes COVID-19) compared to existing test methods that are performed using qPCR. Biodesix currently has a focus on lung disease and offers other diagnostic testing for lung cancer utilizing the ddPCR platform.Click here for more information.
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| "Modeling Cost-Effectiveness of On-Demand Treatment for Hereditary Angioedema Attack" was recently published in the Journal of Managed Care Pharmacy's February 2020 issue. Hereditary angioedema (HAE) is a rare disease that causes painful and potentially fatal episodes of swelling (attacks). HAE attacks can be unpredictable and the need to treat sudden attacks promptly and effectively is critical to minimize risk of hospitalization, morbidity, and mortality. A cost-effectiveness model was evaluated that considers evaluation of on-demand medications, healthcare utilization and patient well-being. For access to the publication, please click here.
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| Biodesix, Inc. announced initiation of the next phase of their biomarker development program with Merck KGaA, Darmstadt, Germany and Pfizer Inc. The companies have completed initial discovery and development of a new proteomic test that identifies likely responders to the anti-PD-L1 checkpoint inhibitor (BAVENCIO®) (avelumab). Development efforts will now focus on transferring the test into Biodesix's CLIA lab in Boulder, CO for clinical phase test validation. The new test was developed through retrospective analysis of the circulating proteome of cancer patients treated with the investigational drug candidate, utilizing the proprietary Biodesix Diagnostic Cortex™ artificial intelligence (AI) platform. Click here to read the full press release.
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| The NAMCP Medical Directors Institute recently held the first meeting of its Executive Leadership Council (ELC) at the recent Fall Managed Care Forum. The NAMCP Medical Directors Institute decided in late 2018 to create the Value Based Care Council (VBCC) with a mission to empower medical directors with information and resources to assist them in making value based decisions that support achieving the Triple AIM of improved outcomes and the patient experience while reducing overall costs. Click here to view an overview of the genesis, formation, and work of NAMCP's Value Based Care Council. Please click here to view the press release.
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| LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced the first patient enrolled in "A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression" (RECOVER). The study will evaluate Vagus Nerve Stimulation Therapy (VNS Therapy) for Treatment-Resistant Depression (TRD) in accordance with the U.S. Centers for Medicare & Medicaid Services (CMS) National Coverage Determination as part of its Coverage with Evidence Development Program. The first patient was enrolled by Dr. Azfar Malik in St. Louis. Click here to read the full press release.
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| Biodesix, Inc. this week highlighted findings from multiple studies demonstrating the significance and clinical utility of its VeriStrat® blood-based proteomic test as a predictive biomarker for patient survival outcomes and as a diagnostic tool to improve the clinical management of patients with non-small cell lung cancer (NSCLC). This information is vital to implementing optimal treatment strategies for patients and supports disease state monitoring. To date, VeriStrat testing has helped more than 50,000 patients in determining the best treatment for their lung cancer. Click here to see the full press release. | |
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