Draft Trusted Exchange Framework Released by HHS
The Department of Health and Human Services today released the draft Trusted Exchange Framework, a significant step towards achieving interoperability, as required by the 21st Century Cures Act of 2016.
The draft Trusted Exchange Framework, issued by HHS’ Office of the National Coordinator for Health Information Technology (ONC), advances Congress’ intent that building and maintaining trust is an important core element in ensuring that health information is available where and when it is needed to manage patient health and care.
“The draft Trusted Exchange Framework we issued today reflects the successes and challenges already existing in the exchange of health information and is designed to help guide the nation on its path to interoperability for all,” said Don Rucker, M.D., national coordinator for health information technology. “The principles and direction we released today, combined with the support of providers, existing health information networks, health IT developers, and federal agencies, are designed to help improve patient care, care coordination, and the overall health of the nation.”
The Trusted Exchange Framework proposes policies, procedures, and technical standards necessary to advance the single on-ramp to interoperability requested by Congress. It will be facilitated through ONC in collaboration with a single Recognized Coordinating Entity (RCE) to be selected through a competitive process. The RCE will use the Trust Exchange Framework policies, procedures, technical standards, principles, and goals to develop a single Common Agreement that Qualified Health Information Networks (Qualified HINs) and their participants will voluntarily agree to adopt. Following a 45-day public comment period and refinements to the draft document, a final draft of the combined Trusted Exchange Framework and Common Agreement will be released. The Trusted Exchange Framework and Common Agreement (TEFCA) will be published in the Federal Register in 2018.
ONC will continue to engage with federal partners, such as the Department of Veterans Affairs (VA) and other stakeholders to establish interoperability that allows health information to be used effectively in care and treatment decisions.
“The Department of Veterans Affairs supports ONC’s efforts to create a common “on-ramp” to health information networks that supports widespread interoperability, said Dr. Carolyn Clancy, VA executive in charge. “We look forward to working with all stakeholders to ensure that our veterans’ health information flows and is available when and where it is needed to support seamless care.”
The proposed Trusted Exchange Framework supports ONC’s goals of achieving nationwide interoperability:
Patient Access – Patients must be able to access their health information electronically without any special effort;
Population-level Data Exchange – Providers and payer organizations accountable for managing benefits can receive population level health information allowing them to analyze population health trends, outcomes, and costs; identify at-risk populations; and track progress on quality improvement initiatives; and
Open and Accessible APIs – The health information technology (health IT) community should have open and accessible application programming interfaces (APIs) to encourage entrepreneurial, user-focused innovation to make health information more accessible and to improve electronic health record (EHR) usability.
The draft Trusted Exchange Framework would not prevent existing or new organizations from creating point-to-point or individual agreements between organizations that have a particular business need to exchange information – while preventing potential information blocking – that may be different from those outlined in the proposal.
Today ONC also released a User’s Guide to Understanding the Trusted Exchange Framework and the US Core Data for Interoperability (USCDI) Glide Path to identify a roadmap for broadening the data that can be exchanged via the TEFCA.
“We know that many stakeholders, including healthcare providers, health systems, developers, and existing health information networks have extensive experience in trust agreements and common exchange networks and strongly encourage stakeholders to share that insight with us,” said Rucker.
The period to comment on the draft Trusted Exchange Framework closes on February 20, 2018. Comments can be submitted at exchangeframework@hhs.gov.
BenchmarkPortal Certifies McKesson Specialty Health’s Third Party Logistics Service Center as Center of Excellence
LaVergne, Tenn.The McKesson Specialty Health Customer Care Contact Center has been certified as a Center of Excellence by BenchmarkPortal for the Third Party Logistics (3PL) Service Title/Non-Title business. This marks the first time that the Customer Care Contact Center in LaVergne, Tennessee has received certification. The Center of Excellence recognition is one of the most prestigious and coveted awards in the customer service and support industry.
BenchmarkPortal uses a rigorous benchmarking process to award the Center of Excellence designation to customer service call centers that are ranked in the top ten percent of call centers surveyed. Call centers are judged against a balanced scorecard of metrics for efficiency and effectiveness drawn from the world’s largest database of quantitative data audited and validated by researchers from BenchmarkPortal. Call centers earn the award by demonstrating superior performance for both cost-related and quality-related metrics when compared to industry peers.
“We are excited about receiving this honor of distinction, demonstrating that we have achieved high levels of performance and customer satisfaction. It is particularly gratifying to be recognized by BenchmarkPortal, the leading call center research consulting organization,” said Leta Gibbs, VP of Customer Care at McKesson Specialty Health. “This was a team effort, based on the success and efforts of all our internal teams, 3PL Services, pharmaceutical manufacturers and agents.”;
McKesson Specialty Health supports successful pharmaceutical commercialization through third-party logistics support services. Supporting pharmaceutical manufacturer partners and key stakeholders with the careful coordination of their specialty products through the entire product life-cycle, McKesson 3PL Services provides pharmaceutical and biotech companies with a seamless service model for patient and customer ease of access. By combining McKesson’s long-standing distribution services’ success with pharmaceutical experience, McKesson 3PL Services help pharmaceutical manufacturers deliver products accurately and on time to hospitals, physician practices, pharmacies and medical clinics.
About McKesson Specialty Health
McKesson Specialty Health, a division of McKesson Corporation, works together with stakeholders across the healthcare delivery system to preserve and strengthen specialty care, passionately driven by the benefits it provides patients and the system as a whole. Through innovative provider, practice management, biopharma and payer solutions, McKesson Specialty Health focuses on improving the financial, operational and business health of our customers and partners so they may provide the best care to patients. At McKesson Specialty Health, we believe that we are all in this together. For more information, visit www.mckessonspecialtyhealth.com.
About Center of Excellence Certification
Contact centers and their managers who wish to implement best practices and attain world-class performance in their industry have a unique opportunity to certify their call centers. BenchmarkPortal’s rigorous certification process has the advantage of referencing all performance goals to their best practice database of thousands of contact centers. Thus, contact centers will be held to performance levels that will improve their competitive position, not just force them to adhere to an arbitrary standard. Please follow the link to discover what the steps to certification are and how they will improve your center’s performance. www.benchmarkportal.com/call-center-certification.
About BenchmarkPortal
Founded in 1995, BenchmarkPortal is a global leader in the contact center industry, providing benchmarking, certification, training, consulting, research and industry reports. The BenchmarkPortal team of professionals has gained international recognition for its innovative approach to best practices for the contact center industry. BenchmarkPortal hosts the world’s largest database of contact center metrics, which is constantly being refreshed with new data. BenchmarkPortal’s mission is to provide contact center managers with the tools and information that will help them optimize their efficiency and effectiveness in their customer communications. For more information on BenchmarkPortal please call 1-800-214-8929 or visit www.BenchmarkPortal.com.
Readout of Acting HHS Secretary Hargan’s visit to CDC headquarters
Acting Health and Human Services Secretary Eric Hargan traveled to Atlanta, Georgia, yesterday to discuss the departmental response to the opioid overdose epidemic and other ongoing public health emergencies with Centers for Disease Control and Prevention (CDC) Director Brenda Fitzgerald, M.D., and Centers for Medicare & Medicaid (CMS) Administrator Seema Verma.
Acting Secretary Hargan visits CDC Headquarters.Acting Secretary Hargan first joined Director Fitzgerald and Administrator Verma at a roundtable at CDC Headquarters, where they were joined by CDC officials to discuss the departmental response to ongoing public health emergencies, including coordinated approaches to scaling up and extending effective strategies to address the opioid epidemic.
At a press conference following the roundtable, all three reaffirmed HHS’s commitment to bringing all resources the Department and the Trump Administration have to bear to address public health emergencies. Specifically, Acting Secretary Hargan highlighted HHS’s five-point strategy to combat the opioid crisis, which includes:
Improving access to prevention, treatment and recovery support services;
Targeting the availability and distribution of overdose-reversing drugs;
Strengthening public health data reporting and collection;
Supporting cutting-edge research on addiction and pain; and
Advancing better practices for pain management.
During today’s visit, Acting Secretary Hargan also participated in a hurricane and preparedness briefing and toured several CDC laboratories and the Emergency Operations Center.
Virginia Cancer Specialists and The US Oncology Network Welcome Dr. Stephanie Akbari
Fairfax, Va. (November 28, 2017) —Virginia Cancer Specialists (VCS) announced that Stephanie Akbari, MD, FACS, has joined the practice. VCS, a practice in The US Oncology Network, is a premier cancer care and research center in Northern Virginia with more than 40 years of service to patients.
Dr. Akbari, the first dedicated breast surgeon in Northern Virginia, has been practicing in the area since 2001. Continually integrating new and innovative technology into treatments, Dr. Akbari established the first nationally accredited breast cancer center in the Washington, D.C., region in 2007. There, Dr. Akbari became the first in the area to become certified in breast ultrasound, incorporate partial breast irradiation, and perform office-based minimally invasive breast biopsies.
“We are delighted to have Dr. Akbari, a true leader in the field in breast cancer treatment, join our growing practice,” said Linda Anderson, executive director of VCS. “With her vision and focus on promising new advancements in breast cancer treatment, Dr. Akbari is a welcome addition to the treatment team as we seek to deliver the very best in cancer care to the Northern Virginia community.”
“It is very exciting to join Virginia Cancer Specialists,” said Dr. Akbari. “Throughout my career, I have admired VCS’s cutting-edge and integrated approach to treating cancer patients. I am thrilled to join this incredible team of professionals dedicated to providing comprehensive breast cancer care, one that has such a long-standing, strong commitment to research.”
Dr. Akbari earned her undergraduate degree from Mount Holyoke College. She received her medical training at the University of Pennsylvania and completed her residency in surgery at Harvard’s New England Deaconess Hospital. She is a fellow of the American College of Surgeons and a member of the American Society of Breast Surgeons, previously serving on committees of both organizations. Since 2005, Dr. Akbari has been recognized as one of the region’s “Top Docs” in breast surgery by Washingtonian Magazine.
About Virginia Cancer Specialists
For more than 40 years, Virginia Cancer Specialists (VCS) has contributed to the campaign against cancer and diseases of the blood. VCS has nine locations throughout Northern Virginia staffed by highly-skilled physicians, each delivering exceptional care. The practice has built a world-class treatment team of cancer specialists, as well as acquiring the very latest treatment technology to help achieve the best outcomes for patients. VCS unites medical and radiation oncologists, breast and musculoskeletal surgeons, hematologists, palliative care physicians, oncology nurse navigators, oncology infusion nurses, radiation therapists, genetic counselors, oncology pharmacists and laboratory technicians. All working together, this team designs the optimal multidisciplinary treatment program, efficiently shares knowledge, executes the treatment plan, and provides a patient-centered, consumer-friendly approach to cancer care. Patients receive the full spectrum of high-quality care necessary to treat their disease from a care team united in their effort to provide each patient with the specific personalized care they need to battle cancer. The physicians at VCS have published more than 100 abstracts and papers over the last few years and have been invited to present at national meetings. To learn more about Virginia Cancer Specialists, please visit www.VirginiaCancerSpecialists.com.
Virginia Cancer Specialists is an affiliate of The US Oncology Network (The Network). This collaboration unites VCS with more than 1,400 independent physicians dedicated to delivering value-based, integrated care for patients—close to home. Through The Network, these independent doctors come together to form a community of shared expertise and resources dedicated to advancing local cancer care and to delivering better patient outcomes. The US Oncology Network is supported by McKesson Specialty Health, whose coordinated resources and infrastructure allow doctors in The Network to focus on the health of their patients, while McKesson focuses on the health of their practices. VCS also participates in clinical trials through US Oncology Research, which has played a role in more than 70 FDA-approved cancer therapies, approximately one-third of all cancer therapies approved by the FDA to date. For more information, visit www.usoncology.com.
Cigna, Good Samaritan Health And Sccipa Form New Alliance To Improve Health Care For Santa Clara County Customers
SAN JOSE, Calif., – Good Samaritan Health System, which includes Regional Medical Center of San Jose, Good Samaritan Hospital, and Santa Clara County IPA (SCCIPA), an independent practice group with over 800 physicians, have entered into an alliance with Cigna to offer a simple, comprehensive and focused approach to quality care with improved affordability in Santa Clara County. Health plans will be available starting January 1, 2018.
The alliance also includes Pacific Partners Management Services (PPMSI), and both PPMSI and SCCIPA participate in the value-based Cigna Collaborative Care program. The Good Samaritan Health System hospitals and Pacific Partners are both subsidiaries of HCA Healthcare.
“By aligning Good Samaritan Health with a customized network of primary care doctors, specialists and hospitals, we’re creating a new kind of collaborative care initiative to offer Santa Clara County customers,” said Peter Welch, president for Cigna’s Northern California market. “Together we can help affiliated providers deliver measurably better care quality at a more affordable price by improving health care outcomes through the greater use of evidence-based best medical practices and more closely connecting the delivery of care for customers in need of acute treatment.”
The alliance will be governed by a joint operating committee comprising representatives from Cigna, Good Samaritan and SCCIPA.
“Together with Cigna and SCCIPA, we can develop health plans that achieve our common goals – better health and affordability, and a better experience for our patients,” said Joseph DeSchryver, chief executive officer, Good Samaritan Hospital. “When providers and payers work collaboratively, we can achieve better value for employers and individuals, greater quality in health care and stronger, healthier communities.”
“SCCIPA is pleased to be the physician network working with Cigna and the Good Samaritan Health System in this new collaboration in Santa Clara County,” said Dr. J. Kersten Kraft, SCCIPA’s president and chairman. “Our physician network has worked well with Cigna in a collaborative care arrangement for several years and has been among the highest performing physician groups in delivering high quality and coordinated health care. Expanding this relationship will bring this excellent care to more patients as they gain access to our doctors.”
The Santa Clara County alliance is Cigna’s fourth local alliance arrangement in California. The company also has local arrangements in Los Angeles, Orange and San Diego counties.
About Cigna
Cigna Corporation (NYSE: CI) is a global health service company dedicated to helping people improve their health, well-being and sense of security. All products and services are provided exclusively by or through operating subsidiaries of Cigna Corporation, including Cigna HealthCare of California, Inc., Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Life Insurance Company of North America, Cigna Life Insurance Company of New York, or their affiliates. Such products and services include an integrated suite of health services, such as medical, dental, behavioral health, pharmacy, vision, supplemental benefits, and other related products including group life, accident and disability insurance. Cigna maintains sales capability in 30 countries and jurisdictions, and has more than 95 million customer relationships throughout the world. To learn more about Cigna®, including links to follow us on Facebook or Twitter, visit www.cigna.com .
About Good Samaritan Health System
The Good Samaritan Health System, which includes Regional Medical Center of San Jose and Good Samaritan Hospital-as well as three surgical centers and three Care Now Urgent Care centers, is committed to providing quality healthcare to residents throughout the greater Silicon Valley community. Good Samaritan Health provides a host of technologically-advanced services including cardiovascular, neurological, orthopedic, bariatric and general surgery, interventional pulmonology, along with multi-organ cancer care, and services for women and children. Good Samaritan Hospital and Regional Medical Center of San Jose are the nation’s first Joint Commission Certified Comprehensive Stroke Centers and are accredited Chest Pain Centers and Community Cancer Centers. For more information about the Good Samaritan Health System, visit www.goodsamhealthsystem.com .
About SCCIPA
SCCIPA operates like a clinic without walls, linking patients and health plans with our established network of physicians, hospitals, lab, x-ray, physical therapy and other providers. Based in San Jose, SCCIPA links over 800 physicians who practice independently throughout Santa Clara County, with 280 primary care physicians — specializing in family practice, internal medicine and pediatrics — and over 550 specialists who practice at most local hospitals.
UnitedHealth Group to Host Investor Conference
NEW YORK, N.Y. (Nov. 20, 2017) —
UnitedHealth Group (NYSE: UNH) will host its annual Investor Conference with analysts and institutional investors in New York City on Tuesday, November 28, 2017, beginning at 8:00 a.m. EST. At the meeting, senior leaders will discuss the Company’s performance and outlook, including reviewing business trends and initiatives related to its various business units and providing financial projections for 2018.
The Company will host a livestream of the presentation and management question and answer portions of this meeting and will make conference materials available on its Investors page at www.unitedhealthgroup.com. A replay of the conference will be available on the Company web site through January 2, 2018.
About UnitedHealth Group
UnitedHealth Group (NYSE: UNH) is a diversified health and well-being company dedicated to helping people live healthier lives and making health care work better for everyone. UnitedHealth Group offers a broad spectrum of products and services through two distinct platforms: UnitedHealthcare, which provides health care coverage and benefits services; and Optum, which provides information and technology-enabled health services. For more information, visit UnitedHealth Group at www.unitedhealthgroup.com or follow @UnitedHealthGrp on Twitter.
FDA Announces Comprehensive Regulatory Plan To Shift Trajectory of Tobacco-related Disease, Death
The U.S. Food and Drug Administration today announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.
Tobacco use remains the leading cause of preventable disease and death in the United States, causing more than 480,000 deaths every single year. In addition to the devastating human toll caused mainly by cigarette smoking, tobacco also causes substantial financial costs to society, with direct health care and lost productivity costs totaling nearly $300 billion a year. A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.
“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users,” said FDA Commissioner Scott Gottlieb, M.D. “Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.”
The FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards. The agency intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes. Because almost 90 percent of adult smokers started smoking before the age of 18 and nearly 2,500 youth smoke their first cigarette every day in the U.S., lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit.
“Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA’s strategy for addressing the devastating, addiction crisis that is threatening American families,” said Commissioner Gottlieb. “Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly-regulated products. To be successful all of these steps must be done in concert and not in isolation.”
The FDA is committed to encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes. To make this effort successful, the agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016. This action will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive. For example, the FDA intends to develop product standards to protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children’s exposure to liquid nicotine. It also will provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency.
The agency plans to issue this guidance describing a new enforcement policy shortly. Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.
Importantly, the anticipated new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco, only the newly-regulated tobacco products such as cigars and e-cigarettes. This approach also will not apply to provisions of the final rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors. It also will not affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., “light,” “low,” or “mild,” or similar descriptors.
In order to further explore how best to protect public health in the evolving tobacco marketplace, the agency also will seek input from the public on a variety of significant topics, including approaches to regulating kid-appealing flavors in e-cigarettes and cigars. In particular, the FDA intends to issue ANPRMs to: 1) seek public comment on the role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery; and 2) solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars, which were included in the FDA’s 2016 rule. Additionally, the agency plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.
“This comprehensive plan and sweeping approach to tobacco and nicotine allows the FDA to apply the powerful tools given by Congress to achieve the most significant public health impact,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use.”
To complement these larger policy considerations, the FDA plans to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission. Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars and guidance documents.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Nestlé Health Science Enters The Microbiome Diagnostics Field Through A Partnership With Enterome
Epalinges, Switzerland, – Nestlé Health Science and Enterome are jointly creating Microbiome Diagnostics Partners (MDP), which aims to lead the development and commercialization of innovative microbiome-based diagnostics with potential to transform therapeutic approaches across a broad spectrum of challenging health conditions, including inflammatory bowel diseases (IBD) and liver diseases. The partnership follows Nestlé Health Science’s initial investment announced in April 2016.
MDP’s initial focus will be accelerating Enterome’s diagnostic programs, which include IBD 110 for the assessment and management of mucosal healing and MET210 for NASH (non-alcoholic steatohepatitis). Current standard of care for these conditions include invasive procedures such as endoscopy and biopsies, rather than a non-invasive stool/serum combined Dx tests that will be developed by MDP. Future innovation efforts will leverage advanced microbial and serum-based metabolic technologies developed respectively at Enterome and Nestlé Health Science’s diagnostics arm Prometheus Laboratories.
Commenting upon the move Greg Behar, CEO of Nestlé Health Science, said, “Microbiome Diagnostics Partners is equipped to lead diagnostic discovery in the microbiome field, opening the door to innovative therapeutic approaches combining diagnostics (Dx), nutritional therapies (Nx) and therapeutics (Rx). Mastering the microbiome is an important facet of our strategy to advance the therapeutic role of nutrition. We also see new opportunities for personalized nutrition both for the healthy population and for patients. The two initial programs have great potential to become differentiated diagnostics.”
Pierre Belichard, CEO of Enterome, said, “The formation of Microbiome Diagnostics Partners is an important milestone for Enterome, as it brings together powerful and complementary technologies and capabilities to enable the creation of a new generation of diagnostic and companion diagnostic products. The MDP joint venture will leverage Enterome’s microbiome-based platforms in diagnostic areas, while Enterome will continue to focus on their application for the discovery of novel small molecule therapeutics.”
TERMS OF THE AGREEMENT
Microbiome Diagnostics Partners (MDP) will be a 50:50 joint venture between Enterome and Nestlé Health Science. Prometheus (a Nestlé Health Science Company) will contribute its Diagnostics (Dx) development and commercialization expertise. Enterome will contribute its current microbiome diagnostic programs and intellectual property (IP) derived from its unique microbiome-based platform for the development of Dx in all therapeutic areas except immuno-oncology.
MDP will be governed by a Board, with Pierre Belichard, CEO of Enterome, becoming Chairman of MDP. Warren Cresswell, General Manager and Head of Prometheus Diagnostics, will become an MDP Board member and assume the role of CEO of MDP. Nestlé Health Science will invest €20 million in return for its 50% stake in MDP and exclusive commercialization options on the initial programs. In addition to this investment, MDP will receive further milestone payments linked to success of clinical and commercial activities.
ABOUT ENTEROME
Enterome is a clinical stage company, pioneering the development of novel pharmaceuticals and diagnostics to support personalized therapies in microbiome-related diseases such as Inflammatory Bowel Disease (IBD), cancer and metabolic diseases. Enterome is also leading the development of new industry standards in gut microbiome quantitative and functional analysis. This technology leadership allows Enterome to open up the new field of therapeutic target discovery in the microbiome in order to address significant unmet medical needs. Enterome has established partnerships with leading pharmaceutical companies and academic research institutes, including Johnson & Johnson Innovation/Janssen Biotech, Takeda and Abbvie in inflammatory bowel and gastro-intestinal diseases; Bristol-Myers Squibb in immuno-oncology; and the Mayo Clinic and Geisinger hospitals in metabolic disorders. The Company was established in 2012 in Paris (France) to develop drugs and diagnostics from its proprietary metagenomic platform and is backed by leading venture capital investors (Seventure Partners, Lundbeckfonden Ventures, Health for Life Capital & Omnes Capital) as well as strategic investors (Nestlé Health Science, BMS, Shire & INRA Transfert). Additional information about Enterome is available through its website: visit http://www.enterome.com/.
GE Healthcare and HeartFlow Announce Global Cardiovascular Collaboration
WASHINGTON, D.C. – GE Healthcare and HeartFlow, Inc. announced today at SCCT2017, the annual scientific meeting of the Society of Cardiovascular Computed Tomography, that they have entered into a global collaboration agreement with the goal of increasing the clinical availability and adoption of HeartFlow FFRct, a proprietary technology that helps clinicians diagnose and treat patients with suspected coronary artery disease (CAD). The collaboration will involve computed tomography (CT) scanners from GE Healthcare with HeartFlow® FFRct, the first and only non-invasive technology that provides insight into both the extent of CAD and the impact of the disease on blood flow to the heart. HeartFlow FFRct is designed to enable clinicians to select a definitive, personalized treatment plan for each patient and reduce the need for additional invasive testing. The agreement will initially focus on the United States, with plans to expand into other markets in the future.
CAD, which affects 16.8 million people in the United States,[i] develops when the coronary arteries narrow, reducing blood flow to the heart and causing angina (chest pain), myocardial infarction (heart attack) and death.
“GE has collaborated with HeartFlow over the last five years, and this agreement reinforces our joint commitment to patients worldwide,” said Scott Schubert, general manager, Global Premium CT, GE Healthcare. “Along with our industry-leading cardiac CT systems and clinical applications, GE can now offer HeartFlow FFRct as an option for healthcare providers who strive to deliver the highest standards in clinical care while reducing costs.”
“This agreement with GE will help bring our game-changing non-invasive technology into the mainstream of cardiac care at thousands of hospitals that are already using state-of-the-art CT systems from GE, which provide exceptional image quality,” said John H. Stevens, M.D., president and chief executive officer of HeartFlow. “By collaborating, we can ensure that HeartFlow FFRct can be easily integrated into existing CAD protocols and more readily transform the care of patients with suspected and potentially life-threatening CAD.”
Diagnosing CAD Definitively and Non-Invasively with GE and HeartFlow
Clinicians diagnosing a patient with suspected CAD want to know as definitively as possible if the patient has a significant blockage in their coronary arteries and the impact of that blockage on blood flow to best determine which treatment pathway is appropriate (e.g., medical management, stenting or coronary artery bypass graft).
With HeartFlow FFRct, data from a patient’s non-invasive coronary CT angiogram are securely uploaded from the hospital’s system to the cloud. Then, HeartFlow leverages deep learning to create a personalized, digital 3D model of the patient’s coronary arteries and uses powerful computer algorithms to solve millions of complex equations to simulate blood flow in the model and assess the impact of blockages on coronary blood flow. The results are provided to the patient’s clinician via a secure web interface to offer actionable information on the optimal course of treatment.
GE brings to the collaboration its leading portfolio of cardiac CT solutions, including:
The Revolution™ family of CT scanners, with innovations including One-Beat Cardiac, SnapShot Freeze intelligent motion correction, and High Definition (HD) imaging with the industry’s highest cardiac spatial resolution;
CardioGraphe™, the world’s first dedicated cardiovascular CT system, a whole-heart coverage CT system that is affordable and accessible; and
AW advanced clinical applications including CardIQ, VesselIQ and TAVI planning to enhance physician diagnostic accuracy and productivity.
Together, the combination of GE and HeartFlow technologies promises to become an important way to assist in diagnosing CAD and guiding appropriate treatment. This combination also could help reduce unnecessary and invasive diagnostic coronary angiography procedures, which can be associated with serious complications, such as bleeding, stroke and major blood vessel damage.[ii]
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
About HeartFlow, Inc.
HeartFlow, Inc. is transforming the way cardiovascular disease is diagnosed and treated. The company’s HeartFlow FFRct is the first available non-invasive solution that enables a physician to more accurately evaluate whether a patient has significant coronary artery disease (CAD) based on both anatomy and physiology. HeartFlow FFRct, which leverages deep learning to create a personalized 3D model of the patient’s arteries, is well positioned to become an integral part of the standard of care for patients who are at risk for CAD because of its potential to improve both clinical outcomes and the patient experience while reducing the cost of care. HeartFlow FFRct is commercially available in the United States, Canada, Europe and Japan. For more information visit www.heartflow.com.
Walgreens Boots Alliance Enters into Agreement with Rite Aid to Buy 2,186 Rite Aid Stores and Related Assets
DEERFIELD, Ill., June 29, 2017 – Walgreens Boots Alliance, Inc. (Nasdaq: WBA) announced today a new definitive agreement with Rite Aid Corporation under which Walgreens Boots Alliance will purchase 2,186 stores, three distribution centers and related inventory from Rite Aid.
The consideration for the transaction will be $5.175 billion in cash, the assumption by Walgreens Boots Alliance of the related real estate leases and the grant of an option to Rite Aid, exercisable through May 2019 and subject to certain conditions, to become a member of Walgreens Boots Alliance’s group purchasing organization, Walgreens Boots Alliance Development GmbH. Walgreens Boots Alliance will also assume certain limited store-related liabilities as part of the new transaction.
This new agreement replaces the previous merger agreement with Rite Aid, announced in October 2015 and amended in January 2017, and the agreement to divest certain Rite Aid stores to Fred’s, Inc. announced in December 2016. Both of these agreements have been terminated, and Walgreens Boots Alliance will pay Rite Aid the $325 million termination fee with respect to their merger agreement.
The new transaction is subject to the expiration or termination of applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other customary closing conditions. The initial closing of the new transaction is expected to occur within the next six months.
Upon the initial closing of the new transaction, Walgreens Boots Alliance will begin acquiring the stores and related assets on a phased basis over a period of approximately six months, and intends to convert acquired stores to the Walgreens brand over time.
Walgreens Boots Alliance expects the new transaction to be modestly accretive to its adjusted diluted net earnings per share in the first full year after the initial closing of the new transaction, and expects to realize synergies from the new transaction in excess of $400 million. These synergies are expected to be fully realized within three to four years of the initial closing of the new transaction and derived primarily from procurement, cost savings and other operational matters.
“This new transaction extends our growth strategy and offers additional operational and financial benefits,” said Walgreens Boots Alliance Executive Vice Chairman and CEO Stefano Pessina. “It will allow us to expand and optimize our retail pharmacy network in key markets in the U.S., including the Northeast, and provide customers and patients with greater access to convenient, affordable care. We believe this new transaction addresses competitive concerns previously raised with respect to the prior transaction and will streamline and simplify the transition for customers, team members and other stakeholders.”
About Walgreens Boots Alliance
Walgreens Boots Alliance (Nasdaq: WBA) is the first global pharmacy-led, health and wellbeing enterprise.
The company was created through the combination of Walgreens and Alliance Boots in December 2014, bringing together two leading companies with iconic brands, complementary geographic footprints, shared values and a heritage of trusted health care services through pharmaceutical wholesaling and community pharmacy care, dating back more than 100 years.
Walgreens Boots Alliance is the largest retail pharmacy, health and daily living destination across the USA and Europe. Walgreens Boots Alliance and the companies in which it has equity method investments together have a presence in more than 25* countries and employ more than 400,000* people. The company is a global leader in pharmacy-led, health and wellbeing retail and, together with the companies in which it has equity method investments, has over 13,200* stores in 11* countries as well as one of the largest global pharmaceutical wholesale and distribution networks, with over 390* distribution centers delivering to more than 230,000** pharmacies, doctors, health centers and hospitals each year in more than 20* countries. In addition, Walgreens Boots Alliance is one of the world’s largest purchasers of prescription drugs and many other health and wellbeing products.
The company’s portfolio of retail and business brands includes Walgreens, Duane Reade, Boots and Alliance Healthcare, as well as increasingly global health and beauty product brands such as No7, Botanics, Liz Earle and Soap & Glory.
In October 2016 Walgreens Boots Alliance received the United Nations Foundation Global Leadership Award for its commitment to the UN’s Sustainable Development Goals. The company also ranks No. 1 in the Food and Drug Stores industry of Fortune magazine’s 2017 list of the World’s Most Admired Companies.
GE Healthcare Receives FDA Indication Approval for Visipaque™ (iodixanol) Injection for use with coronary CT angiography
Chalfont St. Giles, UK, – Broadening its range of diagnostic options for clinicians and their patients, GE Healthcare announced today that it has received an indication approval from the U.S. Food and Drug Administration (FDA) for its imaging agent Visipaque™ (iodixanol) Injection. Visipaque 320 mg Iodine/mL is an iso-osmolar agent that is now approved for use in coronary computed tomography angiography (CCTA) to assist in the diagnostic evaluation of adult and pediatric patients 12 years of age or older with suspected coronary artery disease in the United States.
The new CCTA indication allows healthcare practitioners to image the coronary arteries of patients with suspected coronary artery disease (CAD), offering a non-invasive approach to diagnosis. Traditionally, radiologists and cardiologists have utilized Invasive Coronary Angiography (ICA) procedures to diagnose potential CAD in patients, which can be costly and result in longer patient hospital stays. With Visipaque’s CCTA label extension, healthcare practitioners now have an FDA-approved contrast agent in CCTA procedures that can be performed as an outpatient procedure when evaluating patients with suspected CAD.
According to Matt Budoff, Professor of Medicine at UCLA, “Coronary heart disease is a major cause of death in the United States. We are excited about the label extension of Visipaque™ as the first FDA approved iodinated contrast media for use in CCTA. Having an approved contrast agent for CCTA may facilitate the use of CCTA as a gatekeeper to ICA in patients with mild to moderate coronary artery disease, sparing patients from a more invasive procedure and long recovery times.”
“Technology to image the coronary artery has improved dramatically over the past decade and we are delighted to complement these developments with an extension to the approved use of Visipaque,” said Emmanuel Ligner, General Manager of GE Healthcare’s Core Imaging business. “GE Healthcare is focused on continued innovation and investment in our contrast media portfolio to deliver a range of options for our customers and their patients, and we believe the CCTA label extension is an excellent development for patient care. “
Label extension approval for VISIPAQUE 320 mg Iodine/mL for CCTA was evaluated in two prospective, multicenter clinical studies in a total of 1,106 adult patients. Data from the two studies showed that Visipaque™ has a 99% negative predictive value in the diagnosis of CAD (study 1: sensitivity (76-89%), specificity (84-89%); study 2: sensitivity (95%), specificity (87%))[1]. Visipaque’s label extension further enhances GE Healthcare’s cardiology portfolio , joining, Myoview, Adreview, and the recently announced distribution rights for Rapiscan outside the US and Canada.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
The Cost of a Polluted Environment: 1.7 million Child Deaths a Year, Says WHO
GENEVA – More than 1 in 4 deaths of children under 5 years of age are attributable to unhealthy environments. Every year, environmental risks – such as indoor and outdoor air pollution, second-hand smoke, unsafe water, lack of sanitation, and inadequate hygiene – take the lives of 1.7 million children under 5 years, say two new WHO reports.
The first report, Inheriting a Sustainable World: Atlas on Children’s Health and the Environment reveals that a large portion of the most common causes of death among children aged 1 month to 5 years – diarrhoea, malaria and pneumonia – are preventable by interventions known to reduce environmental risks, such as access to safe water and clean cooking fuels.
“A polluted environment is a deadly one – particularly for young children,” says Dr Margaret Chan, WHO Director-General. “Their developing organs and immune systems, and smaller bodies and airways, make them especially vulnerable to dirty air and water.”
Harmful exposures can start in the mother’s womb and increase the risk of premature birth. Additionally, when infants and pre-schoolers are exposed to indoor and outdoor air pollution and second-hand smoke they have an increased risk of pneumonia in childhood, and a lifelong increased risk of chronic respiratory diseases, such as asthma. Exposure to air pollution may also increase their lifelong risk of heart disease, stroke and cancer.
Top 5 causes of death in children under 5 years linked to the environment
A companion report, Don’t pollute my future! The impact of the environment on children’s health, provides a comprehensive overview of the environment’s impact on children’s health, illustrating the scale of the challenge. Every year:
570 000 children under 5 years die from respiratory infections, such as pneumonia, attributable to indoor and outdoor air pollution, and second-hand smoke.
361 000 children under 5 years die due to diarrhoea, as a result of poor access to clean water, sanitation, and hygiene.
270 000 children die during their first month of life from conditions, including prematurity, which could be prevented through access to clean water, sanitation, and hygiene in health facilities as well as reducing air pollution.
200 000 deaths of children under 5 years from malaria could be prevented through environmental actions, such as reducing breeding sites of mosquitoes or covering drinking-water storage.
200 000 children under 5 years die from unintentional injuries attributable to the environment, such as poisoning, falls, and drowning.
Ongoing and emerging environmental threats to children’s health
“A polluted environment results in a heavy toll on the health of our children,” says Dr Maria Neira, WHO Director, Department of Public Health, Environmental and Social Determinants of Health. “Investing in the removal of environmental risks to health, such as improving water quality or using cleaner fuels, will result in massive health benefits.”
For example, emerging environmental hazards, such as electronic and electrical waste (such as old mobile phones) that is improperly recycled, expose children to toxins which can lead to reduced intelligence, attention deficits, lung damage, and cancer. The generation of electronic and electrical waste is forecasted to increase by 19% between 2014 and 2018, to 50 million metric tonnes by 2018.
With climate change, temperatures and levels of carbon dioxide are rising, favouring pollen growth which is associated with increased rates of asthma in children. Worldwide, 11–14% of children aged 5 years and older currently report asthma symptoms and an estimated 44% of these are related to environmental exposures. Air pollution, second-hand tobacco smoke, and indoor mould and dampness make asthma more severe in children.
In households without access to basic services, such as safe water and sanitation, or that are smoky due to the use of unclean fuels, such as coal or dung for cooking and heating, children are at an increased risk of diarrhoea and pneumonia.
Children are also exposed to harmful chemicals through food, water, air and products around them. Chemicals, such as fluoride, lead and mercury pesticides, persistent organic pollutants, and others in manufactured goods, eventually find their way into the food chain. And, while leaded petrol has been phased out almost entirely in all countries, lead is still widespread in paints, affecting brain development.
Making all places safe for children
Reducing air pollution inside and outside households, improving safe water and sanitation and improving hygiene (including in health facilities where women give birth), protecting pregnant women from second-hand tobacco smoke, and building safer environments, can prevent children’s deaths and diseases.
For example, multiple government sectors can work together to improve the following:
Housing: Ensure clean fuel for heating and cooking, no mould or pests, and remove unsafe building materials and lead paint.
Schools: Provide safe sanitation and hygiene, free of noise, pollution, and promote good nutrition.
Health facilities: Ensure safe water, sanitation and hygiene, and reliable electricity.
Urban planning: Create more green spaces, safe walking and cycling paths.
Transport: Reduce emissions and increase public transport.
Agriculture: Reduce the use of hazardous pesticides and no child labour.
Industry: Manage hazardous waste and reduce the use of harmful chemicals.
Health sector: Monitor health outcomes and educate about environmental health effects and prevention.
Under the Sustainable Development Goals (SDGs) countries are working on a set of targets to guide interventions for children’s environmental health, as well as to end preventable deaths of newborns and children under five by 2030. In addition to SDG 3, which aims to ensure healthy lives and promote well-being for all, other SDGs work to improve water, sanitation and hygiene, transition to clean energy to reduce air pollution, and reverse climate change – all of which will have an impact on children’s health.
GE Healthcare expands MRI contrast media product range in Europe with launch of macrocyclic agent Clariscan
VIENNA, AUSTRIA – Growing its range of magnetic resonance imaging (MRI) contrast media options available to patients and radiologists, GE Healthcare today announced the launch of Clariscan™ (gadoteric acid) at the European Congress of Radiology (ECR) 2017 meeting. Clariscan is a gadolinium-based contrast agent (GBCA) designed to support effective visualisation of abnormalities in the brain, spine and associated tissues, and will be provided alongside GE Healthcare’s comprehensive support services and solutions to healthcare practitioners worldwide.
Emmanuel Ligner, General Manager of Core Imaging for GE Healthcare Life Sciences, said: “Gadolinium-based agents are known to be a gold-standard detection tool in MR imaging, offering improved contrast between normal and pathological tissue to enable rapid detection of abnormalities. It is important that radiologists are able to make a contrast media selection dependent on the needs of individual patients.”
“We are therefore pleased to add Clariscan to the family of GE contrast media and imaging products alongside our existing linear agent for MRI, Omniscan, which has been used in routine diagnostic practice for over 25 years with over 80 million administrations. We believe macrocyclic Clariscan, manufactured using a proprietary GE process, extends choice for radiology professionals, backed by the well-established quality, reliability and surrounding services GE customers have come to expect.”
As a macrocyclic and ionic GBCA, Clariscan is available at a range of doses in vials and pre-filled syringes. It is the latest in a line of products and services provided by GE Healthcare to the radiology community, which include a wide range of contrast media as well as a portfolio of systems and products across MRI, X-ray/CT and ultrasound modalities. GE Healthcare has provided comprehensive partnership and support services to the radiology profession for over 30 years.
Demand for contrast media has significantly increased over the past decade due to rapid procedural advancements in MR imaging, elevating the importance of uninterrupted and sustainable product supply, as well as meeting the individual needs of patients undergoing diagnostic procedures. The company invested over USD 65 million in its worldwide supply network between 2013 and 2016, to increase manufacturing capacity. GE contrast media products are used in more than 70 million procedures per year, equivalent to injection in two patients per second. The company provides best-in-class service and supply of its contrast media portfolio to radiologists across all medical, technical and logistical aspects of imaging.
Clariscan™ has been approved using the decentralised procedure with marketing authorisation in place in Norway. It will be introduced to European countries across 2017. Healthcare professionals are advised to speak to their local GE Healthcare representative for information on local availability.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
Funding Available for Kansas Organizations Improving Access to Health Care in Rural and Frontier Areas
Grants ranging from $40,000 to $50,000 will support organizations that address health needs for Kansans who live in rural and frontier areas
Programs must encourage a “whole person” approach to care, leverage telehealth or incorporate community health workers
UnitedHealthcare accepting RFPs by nonprofits, Federally Qualified Health Centers and other organizations at communitygrants@uhc.com
TOPEKA, Kan. (Feb. 06, 2017) —
UnitedHealthcare is now accepting proposals from community nonprofits and government agencies aimed at improving health resources and programs for Kansas residents living in rural and frontier areas.
The RFP was developed following a community brainstorming session that brought together health care providers and other stakeholders from across the state to develop strategies to address the issue. Initial grants will range from $40,000 to $50,000 each. Funding will be provided to programs and one-time projects for up to 12 months.
Programs and projects must meet at least one of the following priorities:
Integrate behavioral and physical health care systems to encourage a “whole person” approach to care.
Leverage telehealth: behavioral health specialists, primary care/specialists, health educators and peer support.
Further develop workforce/incorporate community health workers.
Kansans who live in rural and frontier areas often have to travel long distances to see a health care provider, and limited options can make accessing preventive, specialty and emergency care challenging. In addition:
According to the Kansas Department of Health and Environment, approximately 30 percent of Kansans live in rural or frontier areas, with more than 80 counties established as areas with shortages of primary care health professionals1.
According to 2016 KIDS COUNT data, youth in rural and frontier Kansas have a higher percentage of teen violent deaths, tobacco use and binge drinking compared to kids in urban and semi-urban Kansas.
In the past year, the number of Kansas children in poverty increased 3.8 percent, according UnitedHealth Foundation’s America’s Health RankingsTM report.
“We recognize the health challenges facing many people living in rural and frontier areas, and welcome the opportunity to partner with the community to improve access to the quality health care that Kansans need and deserve,” said Kevin Sparks, CEO, UnitedHealthcare Community Plan of Kansas.
Qualifying organizations, including Kansas-based nonprofits, Federally Quality Health Centers (FQHCs) and public/government agencies can receive the full RFP by contacting communitygrants@uhc.com. Applicants that do not meet this qualification may apply in partnership with one of the organizations listed above as the lead organization. Proposals are due Feb. 17, 2017. Awardees will be notified by April 28, 2017.
About UnitedHealthcare
UnitedHealthcare is dedicated to helping people nationwide live healthier lives by simplifying the health care experience, meeting consumer health and wellness needs, and sustaining trusted relationships with care providers. The company offers the full spectrum of health benefit programs for individuals, employers, military service members, retirees and their families, and Medicare and Medicaid beneficiaries, and contracts directly with more than 1 million physicians and care professionals, and 6,000 hospitals and other care facilities nationwide. UnitedHealthcare is one of the businesses of UnitedHealth Group (NYSE: UNH), a diversified Fortune 50 health and well-being company. For more information, visit UnitedHealthcare at www.uhc.com or follow @myUHC on Twitter.
McKesson Finalizes Settlement with U.S. Department of Justice and U.S. Drug Enforcement Administration to Resolve Past Claims
SAN FRANCISCO– McKesson Corporation (NYSE:MCK) today announced that it has finalized administrative and civil settlements to resolve U.S. Drug Enforcement Administration (DEA) and U.S. Department of Justice (DOJ) potential federal civil and administrative claims regarding McKesson’s monitoring and reporting of suspicious controlled substance orders. The reporting practices dating back to 2009, and challenged by the DOJ in 2013, are addressed by today’s settlement. Since 2013, McKesson has implemented significant changes to its monitoring and reporting processes. The settlement was previously publicly disclosed in a Form 8-K filed on April 30, 2015, and an accrual for the anticipated settlement payment was reflected in McKesson’s fiscal year 2015 (FY15) financial results.
The settlement represents the conclusion of discussions with the DEA and DOJ over several years regarding McKesson’s interpretation of the DEA’s regulations for the monitoring and reporting of suspicious controlled substance orders. In the interest of moving beyond disagreements about whether McKesson was complying with the controlled substance regulations during the applicable period and to instead focus on the company’s partnership with regulators and others to help stem the opioid epidemic in this country, the company agreed to settle with the DEA and DOJ.
As part of the settlement, McKesson will pay $150 million and the DEA will suspend, on a staggered basis for limited periods of time, McKesson’s DEA registrations to distribute certain controlled substances from four of McKesson’s U.S. Pharmaceutical distribution centers.
In recent years, McKesson U.S. Pharmaceutical has put great effort into implementing significant enhancements to how it monitors and controls the distribution of controlled substances, referred to as the company’s Controlled Substance Monitoring Program (CSMP). McKesson’s team includes numerous individuals with significant regulatory and anti-diversion expertise who play a lead role in its due diligence efforts, utilizing advanced analytical tools to closely monitor our customers’ purchases. McKesson is proud of its CSMP and will continue its efforts to be an industry leader in the fight against prescription drug diversion.
“Pharmaceutical distributors play an important role in identifying and combating prescription drug diversion and abuse. McKesson, as one of the nation’s largest distributors, takes our role seriously. We continue to significantly enhance the procedures and safeguards across our distribution network to help curtail prescription drug diversion while ensuring patient access to needed medications,” said John H. Hammergren, chairman and chief executive officer, McKesson.
McKesson sees prescription drug diversion and abuse as an issue that needs to be addressed through a comprehensive approach that includes the patients who become addicted, doctors who write the prescriptions, the pharmacists who fill them, the distributors who fulfill and deliver pharmacies’ orders, the manufacturers who make and promote the products, and the regulators who license the above activities and determine supply.
“We are committed to tackling this multi-faceted problem in collaboration with all parties in the supply chain that share the responsibility for the distribution of opioid medications,” Hammergren concluded.
McKesson is committed to working with the DEA on an ongoing basis to identify new ways to prevent misuse of controlled substances. As part of the settlement agreement reached, McKesson and the DEA plan to meet regularly over the next five years to ensure ongoing alignment. This new level of partnership with regulators, and the enhancements McKesson has made to its CSMP, strengthens McKesson’s ability to partner with all participants in the prescription drug supply chain to help prevent diversion while ensuring services to meet patient needs.
McKesson, in addition to improving the vigorousness of its CSMP, works to educate its customers about the prevention of prescription drug abuse. The company also advocates for public policies that will help address the problem, including the 2015 passage of the Comprehensive Addiction and Recovery Act (CARA), which contained a number of provisions for preventing and treating addiction. McKesson supports more robust funding of those policy proposals.
About McKesson Corporation
McKesson Corporation, currently ranked 5th on the FORTUNE 500, is a healthcare services and information technology company dedicated to making the business of healthcare run better. McKesson partners with payers, hospitals, physician offices, pharmacies, pharmaceutical companies, and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting. McKesson helps its customers improve their financial, operational, and clinical performance with solutions that include pharmaceutical and medical-surgical supply management, healthcare information technology, and business and clinical services. For more information, visit www.mckesson.com.
Boston Children’s Hospital and GE Healthcare Working Together to Create Smart Imaging Technology to Better Detect Pediatric Brain Disorders
Chicago, Illinois – Boston Children’s Hospital and GE Healthcare today announced a collaboration to develop and commercialize digital solutions to advance the diagnosis and treatment of specific childhood diseases – starting with diseases that affect the brain. The first project, detailed today at the 102nd annual meeting of the Radiological Society of North America in Chicago, Ill., seeks to improve diagnostic accuracy in pediatric brain scans by providing real-time contextual information at the time and place the radiologist needs it.
Every day, tens of thousands of children undergo medical imaging. At Boston Children’s alone, nearly 1,000 imaging studies are performed each day. For general radiologists and pediatric imagers alike, the rapid changes in the body that occur as part of normal childhood development can pose challenges to accurately differentiate normal from abnormal. Keeping up with the ever-growing litany of specific diagnoses can frustrate even the most experienced of radiologists.
Leveraging the software expertise of GE Healthcare, the high-volume computing power of the GE Health Cloud and the clinical knowledge of radiologists at Boston Children’s, the two organizations are working to develop a decision support platform that is intended to help distinguish the large variability in brain MRI scans.
The system will be pre-loaded with normative reference scans from young children of different ages for doctors worldwide to use as a benchmark when reading scans of pediatric patients.
“Interpreting pediatric brain scans requires a specific understanding of the developing brain,” said Richard Robertson, MD, radiologist-in-chief at Boston Children’s. “Since most pediatric imaging is not performed in children’s hospitals by specialists, this new digital tool, once available, will provide non-specialists with access to knowledge and expertise to help effectively diagnose children. We believe that by providing decision support at the time of interpretation, we can improve both the confidence and performance of the interpreting radiologist.”
Ad hoc image databases are often limited to the pediatric departments of major academic institutions. General radiologists without access to such databases lack large reference points and context, which could lead to potential misdiagnosis. Changes in myelination occurring during the first few years of life are particularly likely to be confused with disease states or, conversely, may lead to misinterpretation of the exam as normal for the patient when the abnormality is symmetric in the brain.
“Pediatric brain scans of children under the age of four can be particularly tricky to read because the brain is rapidly developing during this period of childhood,” said Sanjay Prabhu, MBBS, pediatric neuroradiologist at Boston Children’s. “Since pediatric neuroradiologists are very scarce, we approached GE Healthcare to collaborate on the development of digital tools to help physicians of varying expertise read the scans.”
During infancy and childhood, complicated disorders, especially when affecting the brain symmetrically, may be misinterpreted as normal brain maturation. Conversely, normal expected developmental changes are sometimes misinterpreted as pathologic leading to unnecessary follow-on imaging or other diagnostic tests, which can be expensive, stressful and inconvenient to the child and family.
“This brain app that we are targeting to develop will be the first of many digital tools we are creating for our deep learning library, said Charles Koontz, chief digital officer, GE Healthcare. “By 2020, we’ll have hundreds of apps in the GE Health Cloud, enabling insights that will transform healthcare in each disease area and help the seven billion people on earth.”
Boston Children’s is participating via its Innovation and Digital Health Accelerator (IDHA), led by Jean Mixer, VP Strategy and Digital Health, and John Brownstein, PhD, Chief Innovation Officer. IDHA seeks to enable clinicians anywhere in the world to access the hospital’s expertise and data in rare and complex pediatric care through digital tools.
About Boston Children’s Hospital
Boston Children’s Hospital is home to the world’s largest research enterprise based at a pediatric medical center, where its discoveries have benefited both children and adults since 1869. More than 1,100 scientists, including seven members of the National Academy of Sciences, 11 members of the Institute of Medicine and 10 members of the Howard Hughes Medical Institute comprise Boston Children’s research community. Founded as a 20-bed hospital for children, Boston Children’s today is a 404-bed comprehensive center for pediatric and adolescent health care. Boston Children’s is also the primary pediatric teaching affiliate of Harvard Medical School. For more, visit our Vector and Thriving blogs and follow us on our social media channels: @BostonChildrens, @BCH_Innovation, Facebook and YouTube.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE Healthcare (GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions GE Healthcare helps medical professionals deliver great healthcare to their patients. http://www.gehealthcare.com
UN Agencies Scaling Up Emergency Health Services As Mosul Is Made Accessible
United Nations agencies are rapidly scaling up efforts in eastern Mosul to ensure that more than 60,000 people living near the frontlines of the current military operations have access to life-saving care.
Two World Health Organization (WHO) clinics were recently deployed in the city to provide residents with health services aid for the first time since June 2014. A UN Population Fund (UNFPA) mobile unit is providing delivery services to women and girls.
In addition to immediate care, the agencies are restoring services at the primary health care clinic in eastern Mosul through disbursement of medicines and other supplies. The clinic, managed by the Ninewah Department of Health, offers primary health care services, vaccinations, and reproductive health services.
“Civilians in conflict areas have suffered enough. They should not be further exposed to avoidable health risks. Together with national health authorities and health partners, WHO aims to reach all people in newly accessible areas. WHO is providing mobile medical clinics, ambulances, medicines and supplies that ensure life-saving health care for thousands of people affected by Mosul operations,” said Altaf Musani, WHO Representative in Iraq.
WHO and UNFPA expect an increase in patients from Mosul and are accordingly scaling up health services to include three primary health care units and two delivery units. They have also positioned mobile medical units and delivery units at a nearby trauma stabilization point in anticipation of trauma injuries and complex deliveries.
“As new areas become accessible, UNFPA will continue to provide frontline emergency response to meet the reproductive health needs of women and girls including lifesaving medical services to pregnant women. UNFPA is currently supporting and operating 30 mobile/static reproductive health services in total as part of Mosul response operations,” said Ramanathan Balakrishnan, UNFPA Representative in Iraq.
Experts expect new areas in Mosul to become accessible in the coming weeks, which means that more than 200,000 people will need emergency health services. This includes nearly 40,000 people who will require urgent interventions followed by hospital care as well as 8,000 pregnant women needed services for deliveries and newborn care.
The mobile clinics are funded with support from the United States Office of Foreign Disaster Assistance (OFDA), the European Union Aid and Civil Protection Department (ECHO), and the Iraqi humanitarian pooled fund. Additional mobile medical clinics will soon be deployed.
WellCare to Acquire Universal American Corp.
TAMPA, Fla. and WHITE PLAINS, N.Y., Nov. 17, 2016 — WellCare Health Plans, Inc. (NYSE: WCG) and Universal American Corp. (NYSE: UAM) announced today that they have entered into a definitive agreement under which WellCare will acquire Universal American in an all cash transaction valued at $10.00 per share of common stock. This represents a 34 percent premium to Universal American’s 60-day volume-weighted average closing stock price as of November 16, 2016.
WellCare expects to retire Universal American’s outstanding preferred shares shortly after closing and, in connection with the merger, Universal American’s outstanding convertible notes will become convertible and holders will have the right to require their convertible notes to be repurchased. The proposed price for Universal American’s common shares implies an equity value of approximately $600 million. With the retirement of Universal American’s preferred shares and its convertible debt, the transaction would be valued at approximately $800 million. The transaction was approved by the board of directors of WellCare and Universal American. The transaction is expected to be funded through available cash on hand and is expected to close in the second quarter of 2017.
“We are pleased to announce this agreement with Universal American. Their focus on Medicare Advantage makes this transaction a very good strategic fit for WellCare,” said Ken Burdick, WellCare’s CEO. “With approximately 114,000 Medicare Advantage members, and nearly 70 percent enrolled in a 4.0 or higher Star Rating plan, the transaction strengthens WellCare’s Medicare Advantage business in two key local markets – New York and Texas – and gives us a Medicare Advantage presence in Maine. In addition, we intend to leverage their core competency in physician engagement to strategically develop and grow value-based provider relationships.”
“Everyone associated with Universal American has worked tirelessly to bring vibrancy to the Healthy Collaboration® model in which we work closely with our physician partners to improve quality and lower costs for Medicare beneficiaries,” said Richard A. Barasch, Universal American’s Chairman and CEO. “Through this acquisition, WellCare is demonstrating its commitment to this model.”
The acquisition is expected to add approximately 65,000 Medicare Advantage (MA) members in a 4.5-Star plan in Houston-Beaumont, Texas and approximately 14,000 MA members in a 4.0-Star plan in the Northeast, primarily in New York, to WellCare’s Medicare Health Plans membership. In addition, Universal American partners with Accountable Care Organizations (ACO) in 11 states, six of which are WellCare Medicare Advantage markets.
Under the terms of the agreement, Universal American stockholders will receive $10.00 in cash for each share of Universal American common stock. WellCare expects annual synergies of approximately $25 million to $30 million by 2019. The transaction is currently expected to produce $0.60 to $0.70 of accretion to WellCare’s adjusted earnings per share in the first year after closing and $0.70 to $0.80 of accretion in the second year after closing, excluding one-time transaction costs and integration costs. The transaction is subject to approval by Universal American’s stockholders and other customary closing conditions, including regulatory approvals.
About WellCare Health Plans, Inc.
Headquartered in Tampa, Fla., WellCare Health Plans, Inc. (NYSE: WCG) focuses exclusively on providing government-sponsored managed care services, primarily through Medicaid, Medicare Advantage and Medicare Prescription Drug Plans, to families, children, seniors and individuals with complex medical needs. The company served approximately 3.8 million members nationwide as of September 30, 2016. For more information about WellCare, please visit the company’s website at www.wellcare.com.
About Universal American Corp.
Universal American (NYSE: UAM), through our family of healthcare companies, provides health benefits to people covered by Medicare. We are dedicated to working collaboratively with healthcare professionals, especially primary care physicians, in order to improve the health and well-being of those we serve and reduce healthcare costs. For more information on Universal American, please visit our website at www.UniversalAmerican.com.
US Labor Secretary Perez’s Stresses Need For Affordable Child Care
WASHINGTON – The U.S. Department of Labor’s blog today features a post by U.S. Secretary of Labor Thomas E. Perez on the importance of affordable child care for America’s working families.
Please find the post’s text below, or read it here:
“Young children can’t be left alone when a parent goes to work. But too many working families can’t afford the high cost of child care.
For a nation that values both families and hard work, making sure every family has access to quality, affordable child care when they need it seems like a no-brainer. And yet, in 33 states and the District of Columbia, infant care is costlier than in-state public university tuition.
While child care costs vary depending on age, type and location, the high price tag almost always eats up a substantial share of a family’s budget.
The Department of Health and Human Services sets its benchmark for affordable child care for low-income families at 7 percent of a family’s income, which is the national average for all families, according to U.S. Census data.
However, low-income families on average spend approximately four times the share of their income on child care compared to higher-income families, and in 38 states, the average cost of center-based care for an infant alone is over 10 percent of the median income for a two-parent family. An Economic Policy Institute analysis found that for a family with two kids, ages 4 and 8, child care is more expensive than rent in 80 percent of geographic areas analyzed.
Skeptics argue that investing in high-quality, affordable child care is prohibitively expensive. But, as is the case with paid family and medical leave, inaction carries a steep cost for children, families, caregivers and our economy.
Gone are the days when the majority of families had one parent at home with the kids (usually the mother) while the other secured a paycheck. Today, fewer than a quarter of families with children under 14 are married-couple households with a working father and a non-employed mother. Nearly two-thirds of married couples with children under 18 rely on two incomes to make ends meet.
More and more, children are living in homes with only one parent — usually the mother. In 2013, unmarried mothers maintained more than a quarter of all households with children. And while single mothers are more likely than other groups to be in the labor force — meaning they are working or actively looking for work — nearly half of working single mothers are in the bottom 20 percent of earners nationwide, compared with fewer than one in 10 married mothers who work.
Assistance with child care costs boosts employment rates and duration for all families, but the effect is even more pronounced for single mothers, who are 40 percent more likely to be working after two years than those who don’t receive financial support.
Working women are a boon to our economy and family economic security, but most of our public policies — including paid leave, child care, workplace flexibility and other work-family supports — have failed to keep up with these new realities, making it difficult to be both a parent and productive employee. This lack of supportive policies also helps explain why women’s labor force participation plateaued in the late 1990s after decades of growth.
Unfortunately, when American workers stop working or cut back their hours to care for children, they are losing out on up to $8.3 billion in wages each year, according to one recent analysis. And off-ramping from employment for even one year can have negative repercussions for someone’s career, lifetime earnings and retirement security.
Needless to say, it is even harder for low-wage workers and single working parents to afford care.
Here’s an additional irony — because we make insufficient investments in high-quality, affordable child care, wages for child care workers are too low.
That means that too many of the hardworking people who care for our children are low-income themselves and struggle to afford quality care for their own kids. Center-based care may typically be more expensive, but it is also more likely to be licensed and meet basic health and safety standards set by states.
No one should have to choose between the paycheck their family needs and the peace of mind that comes from knowing that they have the high-quality care their children deserve. Supporting working families so that they don’t have to make that choice is just one more reason we need a serious and substantial investment in high-quality, affordable child care.
Editor’s Note: With proper attribution, we grant permission for cross-posting.
Mylan to Launch First Generic to EpiPen® Auto-Injector at a List Price of $300 per Two-Pack Carton, a More than 50% Discount to the Brand Product
HERTFORDSHIRE, England and PITTSBURGH, Aug. 29, 2016 – Mylan N.V. (NASDAQ, TASE: MYL) today announced that its U.S. subsidiary will launch the first generic to EpiPen® Auto-Injector (epinephrine injection, USP) at a list price of $300 per generic EpiPen® two-pack carton, which represents a discount of more than 50% to the Mylan list price, or wholesale acquisition cost (“WAC”), of the branded medicine. The authorized generic will be identical to the branded product, including device functionality and drug formulation. Mylan expects to launch the product in several weeks, pending completion of labeling revisions. Upon launch, the product will be available as a two-pack carton in both 0.15 mg and 0.30 mg strengths. Mylan also intends to continue to market and distribute branded EpiPen®.
Mylan CEO Heather Bresch commented, “We understand the deep frustration and concerns associated with the cost of EpiPen® to the patient, and have always shared the public’s desire to ensure that this important product be accessible to anyone who needs it. Our decision to launch a generic alternative to EpiPen® is an extraordinary commercial response, which required the cooperation of our partner. However, because of the complexity and opaqueness of today’s branded pharmaceutical supply chain and the increased shifting of costs to patients as a result of high deductible health plans, we determined that bypassing the brand system in this case and offering an additional alternative was the best option. Generic drugs have a long, proven track record of delivering significant savings to both patients and the overall healthcare system. The launch of a generic EpiPen®, which follows the steps we took last week on the brand to immediately reduce patients’ out-of-pocket costs, will offer a long-term solution to further reduce costs and ease the burden and complexity of the process on the patient.”
Bresch continued, “Ensuring access to medicine is absolutely the core of Mylan’s mission and has been since our founding 55 years ago. Mylan currently markets approximately 600 products in the U.S., saving our healthcare system hundreds of millions of dollars annually. We also are committed partners to the allergy community and take our responsibilities to serving these patients very seriously. Today’s action further demonstrates this commitment.”
To enhance affordability for the broadest patient population possible, both the augmented patient assistance program and the $300 savings card announced last week will remain in place for the brand product. The $300 My EpiPen Savings Card® acts as cash at the pharmacy and is available at epipen.com/savings. People interested in learning more about the patient assistance program should contact Mylan’s Customer Relations team at 800-395-3376. Mylan also will continue its EpiPen4Schools® program.
In addition, Mylan intends to initiate a direct ship program in conjunction with the launch of the generic at the $300 generic list price. Mylan also continues to fight for enhanced access to epinephrine auto-injectors through other measures, such as inclusion of the product on the federal and private insurance preventive drug lists, which could potentially eliminate all co-pays.
Importantly, Mylan remains fully committed to continuing to meet the needs of this under-served patient population. This includes investing in education and awareness about anaphylaxis, a life-threatening allergic reaction. These efforts have proven vital to ensuring patients are aware of their risk, prepared in the event anaphylaxis occurs, and have access to epinephrine auto-injectors whenever and wherever they need them, at an affordable cost.
About EpiPen® (epinephrine injection, USP) Auto-Injector
EpiPen® (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors are used for the emergency treatment of life-threatening allergic reactions. Each EpiPen 2-Pak® and EpiPen Jr 2-Pak® contains two single auto-injectors, instructions for use and a training device, with no drug product or needle, to help patients become familiar with the administration technique. EpiPen® Auto-Injector should be administered immediately at the first sign of an anaphylactic reaction. EpiPen® Auto-Injector is not a substitute for emergency medical treatment. Patients should seek emergency medical attention immediately following administration. For more information about EpiPen® Auto-Injector, visit epipen.com.
About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 2,700 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 40,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com