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As 2020 comes to a close, NAMCP would like to wish its members, partners and other industry professionals a safe and happy holiday season. As we reflect on the past year for the industry, we would like to provide the readers of the newsbrief a look at the most accessed articles from the year. |
CMS proposes to expand the scope of Medicare coverage determinations
JD Supra
From Sept. 15: On Sept. 1, the Centers for Medicare & Medicaid Services published a proposed rule that would, for the first time, establish formal criteria to define the “reasonable and necessary” standard for Medicare coverage, and would make Medicare coverage available immediately for medical devices deemed to be breakthrough devices by the Food and Drug Administration.
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10 health hacks for 2020
By Victoria Fann
From Jan. 14: A new year is upon us and with it typically comes the desire to get healthy. Here are some health hacks to give your healthy resolutions a jump-start! For example, if sitting is the new smoking, then it's essential to find creative ways to move. Instead of setting aside time to stretch or move, double up! Stretch while waiting for your coffee to brew in the morning, take a 10-minute walk during your lunch break, do yoga while watching television or talking on the phone, dance while doing housework, etc.
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Epic Systems wages interoperability war on CMS
By Scott E. Rupp
From Feb. 11: There's a major hubbub going on in healthcare right now regarding interoperability. This includes a campaign from the CEO of an EHR company to health system leaders encouraging them to rally against federal interoperability reform; tech giants telling the Office of the National Coordinator for Health Information Technology (ONC) to enforce its rules; and Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma suggesting that some healthcare EHR vendors are attempting to protect "short-term profits." Where to start? In this case, we'll begin to break this drama down at the top — with the regulators, CMS.
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TCS is the leading provider of software designed to support health plans, TPAs, ACOs, and other risk-bearing organizations.
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Wide support for House bill to boost CMS alternative pay models
Medscape
From Aug. 4: A newly introduced House bill designed to strengthen the Medicare Shared Savings Program and other Advanced Alternative Payment Models of the Centers for Medicare & Medicaid Services has gained the support of 13 national health stakeholder groups, it was announced on July 24.
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3 tools to help limit or stop your anxiety
By Simma Lieberman
From Jan. 14: I know how debilitating anxiety can be. I've experienced the discomfort of anxiety at different times in my life. Even now, I've found myself feeling anxious about the future, making the right decisions about business and where I want to live. After getting help for extreme anxiety years ago, and learning how common it was, I decided I wanted to help other people. I got trained as a stress management consultant and began working with leaders in organizations to manage their stress and anxieties and support their employees. To this day, I continue to use the techniques I learned and have taught others. I'm sharing three of them with you.
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Apollo delivers evidence-based guidelines in an easy to use format, available 24/7 from any internet-connected device. No software download required. Streamline utilization reviews and lower your costs today. Click here  to begin your risk-free trial, or call to learn more! 888.276.5563
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New Ebola vaccine shows 100% prevention
Nurse.org
From Jan. 14: The Food and Drug Administration announced the release of the world’s first-ever vaccine for the prevention of Ebola virus disease.
Produced by Merck for adults over the age of 18, the live vaccine is called rVSV-ZEBOV, or Ervebo as a trading name, and is effective against the Zaire ebolavirus species of ebolavirus only. The World Health Organization supported the EVD vaccine, and now the FDA has followed suit, in what is being called a “critical milestone” for public health.
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Leveraging payment reforms for COVID-19 and beyond: Recommendations for Medicare ACOs and CMS's interim final rule
Health Affairs
From June 2: The COVID-19 pandemic has significantly challenged clinician practices, hospitals and all health care delivery organizations. Many such organizations have scrambled to build new capabilities and shift workflows to test, trace and manage COVID-19 as well as remotely manage chronic conditions for their non-COVID patients.
At the same time, healthcare delivery organizations are facing considerable financial struggles, with elective procedures and non-urgent office visits down by 70-80% in many practices.
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Promoted by Decipher Biosciences
Decipher predicts overall survival and is the 1st genomic classifier validated in a Phase III, randomized controlled trial in prostate cancer. In RTOG 9601, Decipher identified high-risk patients most likely to benefit from the addition of hormone therapy to salvage radiation. Dan Spratt, MD Associate Professor of Radiation Oncology at University of Michigan
gives his perspective on this important development.
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.NAMCP UPDATES
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| Verrica Pharmaceuticals Inc., a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has resubmitted the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) to the U.S. Food and Drug Administration (FDA). The NDA for VP-102 was resubmitted based on the outcome and final minutes of a Type A meeting with the FDA, which was conducted to obtain clarity on the Complete Response Letter (CRL) issued by the FDA in July 2020. Click here to view the full press release.
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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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