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  • Trump Administration Issues Final Rules Protecting Conscience Rights in Health Insurance

    Trump Administration Issues Final Rules Protecting Conscience Rights in Health Insurance



    (November 7, 2018) - - The U.S. Department of Health and Human Services (HHS) published (today) the following information:

    Today, the Departments of Health and Human Services, Treasury, and Labor released two final rules to provide conscience protections for Americans who have a religious or moral objection to health insurance that covers contraception methods. Under the Affordable Care Act, employer-provided health insurance plans are required to cover certain “preventative services” – which were defined through guidance by the Obama Administration as including all contraception methods approved by the Food and Drug Administration, including methods viewed by many as abortifacients, and sterilization procedures.

    In October 2017, the Trump Administration issued two interim final rules providing an exemption for those who had sincerely held religious or moral objections to such coverage, while seeking public comment on the rules. The first of today’s final rules provides an exemption from the contraceptive coverage mandate to entities that object to services covered by the mandate on the basis of sincerely held religious beliefs. The second final rule provides protections to nonprofit organizations and small businesses that have non-religious moral convictions opposing services covered by the mandate. The religious and moral exemptions provided by these rules also apply to institutions of education, issuers, and individuals. The Departments are not extending the moral exemption to publicly traded businesses, or either exemption to government entities.

    Key Facts:
    • In May 2017, President Trump issued an executive order that the Departments consider amending existing regulations to address conscience-based objections to the contraceptive coverage requirements.
    • Obamacare already exempts tens of millions of people from the preventive services coverage mandate because the mandate does not apply to plans insured through grandfathered coverage that existed prior to the law.
    • The rules leave in place government programs that provide free or subsidized contraceptive coverage to low income women, such as through community health centers.
    • These regulations do not ban any drugs or devices or prohibit any employer from covering contraceptives.
    • The Departments estimate the exemptions should affect no more than approximately 200 employers with religious or moral objections.
    • The rules take effect 60 days after their publication in the Federal Register.
    To read a fact sheet with additional information on the final rules, visit: https://www.hhs.gov/about/news/2018/...-care-act.html

    To read the final rule on exemptions for religious beliefs, visit: https://www.federalregister.gov/docu...ices-under-the

    To read the final rule on exemptions for moral convictions, visit: https://www.federalregister.gov/docu...the-affordable




    Credit: U.S. Department of Health and Human Services
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  • U.S. Government Participates in Fifth Annual Global Health Security Agenda Ministerial Meeting

    U.S. Government Participates in Fifth Annual Global Health Security Agenda Ministerial Meeting




    (November 2, 2018) - - Today, the U.S. Department of Health and Human Services (HHS) published the following information:

    On November 4-6, 2018, Health and Human Services Deputy Secretary Eric Hargan will attend the Fifth Global Health Security Agenda (GHSA) Ministerial Meeting in Indonesia, which will officially launch the next five-year phase of GHSA, known as GHSA 2024. Delivering on President Trump’s commitment to global health security, he will lead the multi-sectoral U.S. delegation, including representatives from the Departments of Health and Human Services, State, Defense, Agriculture, the U.S. Agency for International Development, and the National Security Council.

    In Indonesia, the U.S. delegation will hold bilateral meetings with government officials from GHSA member countries to discuss ongoing collaborations between the U.S. and our partners on global health security. At the meeting HHS Secretary Alex Azar will deliver a video message and Deputy Secretary Hargan will deliver remarks on behalf of the Trump Administration, reaffirming U.S. support for GHSA and underscoring the goal to prevent, detect, and respond to infectious diseases.

    Following the GHSA Ministerial Meeting, Deputy Secretary Hargan will travel to Thailand and Laos to underscore the U.S. commitment to global health security and to meet with partners in the region who are crucial to our efforts in addressing global health security concerns such as influenza, artemisinin-resistant malaria, dengue, and tuberculosis.

    On November 7, Deputy Secretary Hargan will travel to Thailand where he will visit the CDC Bamrasnaradura Infectious Disease Institute laboratories, Bumrungrad Hospital, and meet with his Thai counterparts as well CDC staff in country. This is the 200th year of friendship between the U.S. and Thailand, and his visit will highlight the important work on health we do together as nations. On November 9, Deputy Secretary Hargan will arrive in Vientiane, Laos, to meet with the Ministry of Health before traveling back to the U.S. on November 10. Laos is an important partner in our global efforts to combat emerging and re-emerging disease threats.

    Additional information regarding Deputy Secretary Hargan’s meetings is forthcoming and will be released via social media posts.

    Background:

    Launched in 2014, GHSA is a worldwide effort to help build countries’ capacity to help create a world safe and secure from infectious disease threats and elevate global health security as a national and global priority. Through a growing multisectoral partnership of international organizations, non-governmental stakeholders, and more than 60 countries, GHSA is accelerating efforts to build countries’ capacity to prevent, detect, and respond to infectious diseases.





    Credit: U.S. Department of Health and Human Services
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  • U.S. Department of Health and Human Services Office for Civil Rights Releases - - Here to Serve You - - Educational Video in Spanish

    U.S. Department of Health and Human Services Office for Civil Rights Releases “Here to Serve You” Educational Video in Spanish



    (November 1, 2018) - - The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has released an educational video in Spanish to raise awareness within the Hispanic community about the work of OCR and to highlight important conscience and religious freedom rights protected by our federal laws.

    “Because respect for the conscience and religious freedom rights of patients and providers ensures diversity in healthcare, we are reaching out to the Spanish speaking community to foster greater understanding of the laws protecting our first freedoms,” said Roger Severino, OCR Director.

    In this video, Director Severino highlights the new Conscience and Religious Freedom Division and describes the work of all of OCR’s divisions in order to help patients, healthcare providers, stakeholders, and the public know their rights and responsibilities and how to file a complaint with OCR if they think that their rights have been violated. OCR protects and enforces civil rights laws in health and human services, including health information privacy and security (HIPAA); laws prohibiting discrimination based on race, national origin, age, sex, or disability; and laws protecting conscience and religious freedom.

    To view the “Here to Serve You” video and for more information about the work of OCR, please visit www.hhs.gov/ocr .




    Credit: U.S. Department of Health and Human Services
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  • U.S. Department of Health and Human Services Announces the Official Opening of the Health Sector Cybersecurity Coordination Center

    U.S. Department of Health and Human Services Announces the Official Opening of the Health Sector Cybersecurity Coordination Center



    (October 30, 2018) - - On Monday, October 29, the Deputy Secretary of the Department of Health and Human Services (HHS), Eric Hargan, announced the official dedication of the Health Sector Cybersecurity Coordination Center (HC3) at an official opening ceremony in the Hubert H. Humphrey building. As part of October’s National Cybersecurity Awareness Month, and in coordination with the Administration’s rollout of the National Cyber Strategy, the opening underscores HHS’ commitment to support and improve the health sector’s cybersecurity defenses.

    “HHS is proud to work with the health community to better protect Americans’ health data and confidential information,” Deputy Secretary Hargan said. “Today’s announcement is a recognition of the importance we place on stakeholder engagement as part of our cybersecurity work.”




    (Photo courtesy U.S. Department of Health and Human Services)



    The U.S. Government recognizes the importance of protecting America against cyber attacks, reaffirming in the most recent National Cyber Strategy that protecting American information networks is vital to protecting the American way of life. The Administration has designated the Department of Homeland Security (DHS) as the lead organization to combat these threats and develop preventive strategies across the entire economy, with HHS given the role to focus cybersecurity support on information sharing within the healthcare and public health (HPH) sector.

    “We believe that when a risk is shared across sectors, the only way to manage that risk successfully is to manage it collectively,” said Jeanette Manfra, Assistant Secretary for Cybersecurity and Communications in DHS. “We know that the majority of the cybersecurity attacks that occurred over the past year could have been prevented with quality and timely information - and the heightened importance of sharing information cannot be stressed enough. The HC3 is a vital capability for the early detection and coordination of information between the private sector and the federal government, and with cyber professionals across the federal government.”

    This mission is now more important than ever with the healthcare sector reporting over 400 major breaches from 2017 to 2018. Within the HPH sector, the threats are significant and hackers covet having the potential to access sensitive medical data, damage medical equipment, secure intellectual property for financial gain, or even conduct terrorist attacks. The HC3 provides a service to healthcare organizations that enables them to protect their assets and patients.

    To address these threats to the sector, HHS has developed a “coordination center” in the HC3 to coordinate the activities across the sector and report to DHS threats, profiles, and preventive strategies. The HC3’s role is to work with the sector, including practitioners, organizations, and cybersecurity information sharing organizations to understand the threats it faces, learn the bad guys’ patterns and trends, and provide information and approaches on how the sector can better defend itself.

    The official opening ceremony comes after extensive stakeholder consultation collaborating with partners that are all working together to defend the health sector’s information technology infrastructure and to strengthen coordination of information sharing.

    The Health Sector Cybersecurity Coordination Center (HC3) is an operational cybersecurity center designed to support and improve the cyber defense of the healthcare and public health sector. HC3 strengthens coordination and information sharing within the sector and cultivates cybersecurity resilience by providing timely and actionable cybersecurity intelligence to health organizations and developing strategic partnerships between these organizations.



    Credit: U.S. Department of Health and Human Services...
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  • U.S. Health and Human Services Secretary Azar Declares Public Health Emergency in US Territory Due to Super Typhoon Yutu

    U.S. Health and Human Services Secretary Azar Declares Public Health Emergency in US Territory Due to Super Typhoon Yutu




    (October 25, 2018) - - Health and Human Services (HHS) Secretary Alex Azar today declared a public health emergency in the Commonwealth of the Northern Marianas Islands (CNMI), a U.S. territory, due to damage from Super Typhoon Yutu. The declaration follows President Trump’s emergency declaration for the territory and gives the HHS Centers for Medicare & Medicaid Services beneficiaries and their healthcare providers and suppliers greater flexibility in meeting emergency health needs.

    “We are working closely with territory health authorities, the local hospital and other healthcare facilities to save lives and protect health after this catastrophic storm,” said HHS Secretary Alex Azar. “This declaration will help ensure that our fellow Americans who rely on Medicare and Medicaid have continuous access to the care they need.”

    Super Typhoon Yutu hit the islands yesterday as a category 5 storm causing widespread damage.

    Before the storm, CMS also worked with dialysis centers in the CNMI to encourage early dialysis of patients and activated the Kidney Community Emergency Response Program to monitor dialysis access and needs of these facilities after the typhoon.

    HHS moved more than 50 medical and public health personnel along with their caches of medical supplies and equipment into Guam, the closest large territory to the CNMI before the storm; these personnel are ready to respond to medical and public health needs that CNMI officials identify in the storm’s aftermath. Additional personnel are staged or on alert from the National Disaster Medical System and the U.S. Public Health Service Commissioned Corps.

    In addition to providing basic medical care, HHS teams can assist Urban Search and Rescue teams in triaging people found, support the health department with disease surveillance, offer behavioral health support for residents and responders, and more. HHS incident managers are working with CNMI officials to determine what federal medical and public health support is needed.

    To assist residents in the impacted area in coping with the stress of the disasters, the Substance Abuse and Mental Health Services Administration activated the Disaster Distress Helpline. The Disaster Distress Helpline provides immediate 24/7, 365-days-a-year crisis counseling and support to people experiencing emotional distress related to natural or human-caused disasters. This toll-free, multilingual, and confidential crisis support service is available to all residents in the United States and its territories. Stress, anxiety, and other depression-like symptoms are common reactions after a disaster. Call 1-800-985-5990 to connect with a trained crisis counselor.

    Additionally, the HHS Office for Civil Rights (OCR) has guidance available for territory agencies and community organizations to help ensure equal access to emergency services and the appropriate sharing of medical information during emergencies, including how federal civil rights laws apply in an emergency, how HIPAA laws apply in an emergency. OCR also provided a HIPAA Disclosures for Emergency Preparedness Decision Tool.

    In declaring the public health emergency, in CNMI and authorizing flexibilities for CMS beneficiaries, Secretary Azar acted under his authority in the Public Health Service Act and Social Security Act. These actions and flexibilities are retroactive to Oct. 24, 2018.

    Public health and safety information for Super Typhoon Yutu can be found on the HHS emergency website, https://www.phe.gov/emergency/events...s/default.aspx.




    Credit: U.S. Department of Health and Human Services...
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  • U.S. Departments of the Treasury, Health and Human Services, and Labor Announce Proposal to Expand Access to Quality, Affordable Health Coverage

    U.S. Departments of the Treasury, Health and Human Services, and Labor Announce Proposal to Expand Access to Quality, Affordable Health Coverage



    Washington, DC - - (October 23, 2018) - - The U.S. Departments of the Treasury, Health and Human Services, and Labor today issued a proposed regulation that expands the usability of health reimbursement arrangements (HRAs). HRAs are designed to give working Americans and their families greater control over their healthcare by providing an additional way for employers to finance quality, affordable health insurance. This proposed regulation is in response to President Trump’s Executive Order on “Promoting Healthcare Choice and Competition Across the United States,” and will benefit hundreds of thousands of businesses and millions of workers and their families in the coming years.

    “Today’s proposed regulations will expand the availability of affordable health insurance for hardworking Americans. This fulfills the commitment the President made in his October 2017 Executive Order to foster competition and choice and to provide Americans - especially employees who work at small businesses - with more options for financing their healthcare. Treasury projects that this will benefit hundreds of thousands of employers and millions of workers,” said U.S. Secretary of the Treasury Steven T. Mnuchin.

    “Today’s announcement is another example of President Trump’s delivering on his promise to provide for more affordable healthcare options for the American people. More access to association health plans, short-term insurance, and flexible HRAs complement the work we are doing at HHS to bring down drug prices and lower the cost of healthcare services. Each of these actions is focused on empowering patients through transparency, choices, and competition,” said U.S. Secretary of Health and Human Services Alex Azar.

    “Of those smaller employers that provide health benefits, 81 percent offer only a single option. This proposal is about empowering American workers to have more consumer-driven healthcare choices. Health Reimbursement Arrangements can provide another way for employers to help their employees access quality, affordable health coverage,” said U.S. Secretary of Labor Alexander Acosta.

    HRAs allow employers to reimburse their employees for medical expenses in a tax-favored way. Current regulations, issued by the previous administration, prohibit employers from using HRAs to reimburse employees for the cost of individual health insurance coverage. Undoing that prohibition, the proposed regulation would permit HRAs to reimburse employees for the cost of individual health insurance coverage, subject to certain conditions. These conditions mitigate the risk that health-based discrimination could increase adverse selection in the individual market, and include a disclosure provision to ensure employees understand the benefit.

    Because medical expense reimbursements from HRAs are tax-preferred, HRAs - that workers and their families use to purchase coverage of their choosing - provide the same tax advantage enjoyed by traditional employer-sponsored coverage. The proposed regulation would not alter the tax treatment of traditional employer-sponsored coverage. It would merely create a new tax-preferred option for employers of any size to use when funding employee health coverage. While the employer would fund the cost of individual health insurance coverage, the employee would own the coverage, allowing the employee to keep the coverage even if he or she left the employer and was no longer covered by the HRA.

    In the near term, the proposed regulation, if finalized, would provide opportunities to employers, especially small and mid-size employers who have struggled to offer coverage, to fund the cost of individual health insurance coverage on a tax-preferred basis. The fact is that, currently, many employers simply cannot afford to offer traditional, employer-sponsored coverage to their employees as a result of the significant costs, including the administrative burdens, associated with identifying and managing such health plans.

    Some small businesses and their employees have been hit hard by rising costs, driven in part by Obamacare. For firms that employ 3-to-24 workers, the percentage of workers covered by employer health benefits has fallen from 44 percent in 2010 to 30 percent in 2018. For firms that employ 25-to-49 workers, the percentage of workers covered by employer health benefits has fallen from 59 percent in 2010 to 44 percent in 2018.

    Small and mid-size businesses that continue to offer coverage to their workers generally only make a single plan available. In fact, 81 percent of small employers (fewer than 200 employees), and even 42 percent of large employers, offering health benefits only provide a single coverage option for their employees. The proposed regulation, therefore, could dramatically increase the choices of coverage available for America’s workers and their families.

    In the long term, by increasing choice, the proposed regulation, if finalized, has the potential to spur a truly competitive, value-driven health insurance market that empowers people to shop for their own health plans and, by virtue of consumer choice, drive health plans to deliver higher quality coverage at lower cost. The proposed regulation holds the potential of transformative impact on the health insurance landscape in the coming years.

    Separately, in addition to allowing HRAs to reimburse the cost of individual health insurance coverage, the proposed regulation would allow employers offering traditional employer-sponsored coverage to offer an HRA of up to $1,800 per year (indexed annually for inflation) to reimburse an employee for certain qualified medical expenses, including premiums for short-term, limited-duration insurance plans.

    According to preliminary estimates from the Treasury Department, once employers and employees have fully adjusted to the new rule, roughly 800,000 employers are expected to provide HRAs to pay for individual health insurance coverage to over 10 million employees. It is also possible that this proposed regulation would produce better incentives for both consumers and providers and thus will improve the overall healthcare system, as well as potentially increase workforce investment and wages. Moreover, the proposed regulation would better enable businesses to focus on what they do best - on serving their customers - and not on navigating and managing complex health benefit designs.

    The proposed regulation can be found here, and a fact sheet can be found here.

    Comments on the proposed regulation are requested by December 28, 2018. The regulation, if finalized, is proposed to be effective for plan years beginning on and after January 1, 2020.





    Credit: U.S. Department of Labor
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  • U.S. Department of Health and Human Services Activates Aid for Uninsured Floridians Needing Medicine after Hurricane Michael

    U.S. Department of Health and Human Services Activates Aid for Uninsured Floridians Needing Medicine after Hurricane Michael



    (October 18, 2018) - - Thousands of uninsured Floridians are eligible for no-cost replacements of critical medications lost or damaged by Hurricane Michael. This relief comes from the Emergency Prescription Assistance Program (EPAP), managed by the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).

    The program pays for prescription medications for people without health insurance who are affected by disasters. More than 4,900 Florida pharmacies participate in EPAP, and more than 72,000 pharmacies participate nationwide.

    “The Emergency Prescription Assistance Program provides vital assistance to people without insurance who rely upon certain prescription medicines to protect their health after disasters,” said HHS’ Assistant Secretary for Preparedness and Response Robert Kadlec, M.D. “I encourage citizens in Florida who can use this assistance to take advantage of it to ensure they have an adequate supply of the medicines they need.”

    At no cost to uninsured patients, those needing certain prescription medications during an emergency can obtain a 30-day supply at any EPAP participating pharmacy through Nov. 15. Most prescription drugs exit disclaimer icon are available.

    Uninsured patients also may use the program to replace specific medical supplies, vaccines or medical equipment, such as canes and walkers, damaged or lost as a direct result of Hurricane Michael or as a secondary result of loss or damage caused while in transit from the emergency site to an emergency shelter.

    EPAP provides an efficient mechanism for enrolled pharmacies to process claims for prescription medication, specific medical supplies, vaccines and some forms of durable medical equipment for eligible individuals in a federally identified disaster area.

    Uninsured Floridians affected by Hurricane Michael can call 855-793-7470, to learn if their medication or specific durable medical equipment is covered by EPAP and to find a participating pharmacy or visit www.phe.gov/epap .

    HHS also has Disaster Medical Assistance Teams working alongside local healthcare providers to care for emergency department patients at damaged or overwhelmed hospitals. In addition, these federal medical teams have triaged people found by Urban Search and Rescue and provided basic medical care for residents in local emergency shelters. Since arrival, these teams have seen more than 1,500 patients.

    A U.S. Public Health Service Commissioned Corps behavioral health team also is providing behavioral health support for emergency responders.

    The U.S. Food and Drug Administration has information available to help citizens understand the safe use of medical products, including insulin and devices, exposed to flooding or unsafe water after Hurricane Michael. This information includes the safe use of temperature-sensitive drugs when refrigeration is temporarily unavailable.

    The FDA also continues to monitor Hurricane Michael’s impact on companies that develop products the FDA regulates, including medicines, medical devices, food, and the blood supply, to help ensure safety and availability. There have been no reports of significant impacts on companies that produce critically important medical products, and no shortages of these products are expected at this time.

    Centers for Disease Control and Prevention subject matter experts are working with the state health department to determine and meet any long-term public health effects of the hurricane and providing public health information such as safe clean up and preventing common post-disaster diseases.

    The Centers for Medicare & Medicaid Services is providing waivers and flexibilities to assist healthcare providers and suppliers in providing necessary care and services to beneficiaries throughout the emergency.

    CMS is working with the Kidney Community Emergency Response network and dialysis providers to check on the well-being of dialysis patients and reschedule their dialysis services at open dialysis facilities after the hurricane.

    The Substance Abuse and Mental Health Services Administration activated its Disaster Distress Helpline, a 24/7, 365-day-a-year, national hotline dedicated to providing immediate crisis counseling for people who are experiencing emotional distress related to any natural or human-caused disaster. The Disaster Distress Helpline is toll-free, multilingual, and confidential. Stress, anxiety, and other depression-like symptoms are common reactions after a disaster. Call 1-800-985-5990 or text TalkWithUs to 66746 (for Spanish, press 2 or text Hablanos to 66746) to connect with a trained crisis counselor. The helpline has received almost 200 calls from Floridians in the past week.

    HHS Secretary Alex Azar declared public health emergencies in Florida and Georgia to authorize flexibilities for CMS beneficiaries, following President Trump’s emergency declarations in those states due to Hurricane Michael. These actions and flexibilities are retroactive to Oct. 9, 2018, in Georgia and Oct. 7, 2018, in Florida.

    HHS, through ASPR, leads the federal government’s public health and medical response and recovery support for states and territories after disasters. HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. ASPR’s mission is to save lives and protect Americans from 21st century health security threats.

    Information on disaster health and HHS actions is available on www.phe.gov/emergency . Public Service Announcements with post-storm health tips are available on https://www.cdc.gov/disasters/psa/index.html .





    Credit: U.S. Department of Health and Human Services...
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  • U.S. Department of Veterans Affairs Forms Search Commission to Locate Candidates for the Under Secretary for Health

    U.S. Department of Veterans Affairs Forms Search Commission to Locate Candidates for the Under Secretary for Health



    Washington, DC - - (October 4, 2018) - - The U.S. Department of Veterans Affairs (VA) on Oct. 1 established a search commission, who will help identify candidates for the Under Secretary for Health position, which oversees the Veterans Health Administration (VHA).

    VA has identified individuals who possess the expertise and willingness to serve on this important commission, with experience that is broad, relevant and consistent with the requirements established by law.

    The following individuals were appointed to serve as members of the commission to identify the best qualified candidates to serve as VA’s Under Secretary for Health:
    • Jim Byrne, VA acting deputy secretary
    • Anthony Principi, chairman of the search commission as designated by the VA Secretary
    • Dr. Don Wright, deputy assistant secretary for Health, Director Office of Disease Prevention and Health Promotion, Department of Health and Human Services
    • Dr. James Adams, senior vice president and chief medical officer, Northwestern University
    • Thomas McCaffery, principal deputy assistant secretary of Defense Health Affairs, U.S. Department of Defense
    • Sarah Verardo, executive director, Independence Fund
    • Garry Augustine, executive director, Disabled American Veterans
    • Dr. Jonathan Simons, president and CEO, Prostate Cancer Foundation
    • Dr. Jon Perlin, chairman of the Special Medical Advisory Group.

    “We are committed to selecting the best nominee to lead America’s largest integrated health care system,” said VA Secretary Robert Wilkie. “This commission has a significant mission and I am confident they will use all their collective talents to make a strong recommendation.”

    Candidates for the Under Secretary for Health position must demonstrate the knowledge, vision and dedication to lead VHA in strategic change efforts to realize President Trump’s vision of transforming VA. By law, the appointment is made without regard to political affiliation and solely on the basis of demonstrated ability in the medical profession, health care administration and policy formulation, or in health care fiscal management; and substantial experience in connection with VHA programs or programs of similar content and scope.

    With an annual budget of about $74 billion, VHA provides care to more than 9 million Veterans enrolled in VA health care programs at 1,243 facilities, including 172 VA Medical Centers and 1,062 outpatient sites of varying complexity. VHA is the nation's largest provider of graduate medical education and a major contributor to medical and scientific research.

    Completed applications must be received by 11:59 p.m. (EST) on the closing date of Oct. 17, 2018, to be considered. Interested applicants can apply online at the federal government’s USAJOBS website at https://www.usajobs.gov/GetJob/ViewDetails/512725400 . Applications can also be emailed to VAUSH@va.gov .




    Credit: U.S. Department of Veterans Affairs
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  • U.S. Department of Health and Human Services Announces 2.6 Million Dollars in Prizes to Redesign Dialysis as Part of KidneyX

    U.S. Department of Health and Human Services Announces $2.6 Million in Prizes to Redesign Dialysis as Part of KidneyX




    (September 28, 2018) - - The U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN) have committed $2,265,000 in prize money for “KidneyX: Redesign Dialysis,” a prize competition that challenges the public to develop better treatment options for patients with kidney failure. This prize competition is the first in a planned series of Kidney Innovation Accelerator (KidneyX) prize competitions designed to develop innovative solutions that can prevent, diagnose, and/or treat kidney diseases.

    “With this first prize, KidneyX: Redesign Dialysis, we are looking for solutions that completely disrupt the way kidney failure is currently treated,” said Ed Simcox, HHS Chief Technology Officer, “We are asking innovators like engineers and scientists to propose and develop new technologies to redesign treatment for kidney failure. We look forward to seeing what the best and brightest envision for the future of kidney failure treatment in the first phase of Redesign Dialysis.”

    “In addition to redesigning dialysis, we are also redesigning how HHS tackles complex problems,” said Sandeep Patel, HHS KidneyX Program Director. “Innovators currently must navigate a disjointed and expensive path to bring new products and practices to market. KidneyX has brought together colleagues across our funding (National Institutes of Health), regulatory (Food and Drug Administration), and payment (Centers for Medicare & Medicaid Services) roles to offer a more coherent and transparent path for innovators.”

    HHS and ASN designed this first prize after a year of gathering input from key stakeholders, including patients, nephrologists, investors, and researchers through listening sessions, Twitter chats and two Requests For Information.

    The Redesign Dialysis prize will run in two phases with a total prize purse of $2,625,000. The first phase, which will award up to 15 prizes of $75,000 each, launching in late October and running through February 2019 asks participants to design solutions or components of solutions that can replicate normal kidney functions and improve patient quality of life. The second phase, planned to run from April 2019 to January 2020, will ask participants to develop initial prototypes; this phase will award up to 3 prizes of $500,000 each. Participants may compete in the second phase even if they do not submit a solution in the first phase.

    Mark D. Okusa, MD, FASN, President of the American Society of Nephrology added, “The American Society of Nephrology is excited and honored to partner with HHS to collaborate on the first KidneyX Prize: Redesign Dialysis. We hope to attract new interest, potential collaborators, and ideas from across the medical and scientific communities to accelerate the development of disruptive new therapies.”

    Submissions for the first phase of the Redesign Dialysis prize will launch on Thursday, October 25, 2018 at ASN Kidney Week 2018. For more information on the ReDesign Dialysis prize visit, hhs.gov/idealab




    Credit: U.S. Department of Health and Human Services...
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  • U.S. Department of Veterans Affairs Awards New Leases to Provide Health Care Facilities to Veterans

    U.S. Department of Veterans Affairs Awards New Leases to Provide Health Care Facilities to Veterans



    Washington, DC - - (October 2, 2018) - - The U.S. Department of Veterans Affairs (VA) recently awarded 13 major leases to improve access to care and deliver health care facilities to Veterans.

    These awards are a result of VA’s leasing business transformation effort to improve the timeliness of the lease procurement process.

    “These awards are the next step in increasing access for our Veterans across the country,” said VA Secretary Robert Wilkie. “VA stands firm in ensuring our Veterans are treated in state-of-the-art facilities and continue to access the high quality of care VA is able to provide.”

    The transformation effort aims better to align VA’s lease procurement processes with those of the private sector and other federal agencies, with an emphasis on increased competition, cost savings and speed to market. The following developers and locations were selected after a competitive lease procurement process:
    • Charleston, South Carolina, Primary Care — Size: 75,000 Net Usable Square Footage (NUSF). Developer: Carnegie Management and Development Corp.; site location: Corner of Rivers Avenue and Hanahan Road, North Charleston, South Carolina
    • Chattanooga, Tennessee, Community Based Outpatient Clinics (CBOC) — Size: 75,000 NUSF. Developer: U.S. Federal Properties Co., LLC; site location: 6401 Shallowford Road, Chattanooga, Tennessee
    • Houston, Texas, Research and Development — Size: 47,942 NUSF. Developer: Texas Medical Center; site location: 2450 Holcombe Blvd., Suite 1, Houston, Texas 77021
    • Lincoln, Nebraska, CBOC — Size: 72,000 NUSF. Developer: Johnson Development, LLC; site location: 600 South 70th St., Lincoln, Nebraska 68510
    • Lubbock, Texas, CBOC — Size: 94,000 NUSF. Developer: U.S. Federal Properties Co. LLC; site location: Northeast corner of Fourth St. and Knoxville Avenue in Lubbock, Texas
    • Myrtle Beach, South Carolina, CBOC — Size: 84,000 NUSF. Developer: GuvCar, LLC; site location: Northwest corner of Howard Avenue and Airpark Drive, Myrtle Beach, South Carolina
    • New Port Richey, Florida, CBOC — Size: 114,000 NUSF. Developer: SASD Development Group LLC; site location: 7932 Little Road, New Port Richey, Florida 34654
    • Phoenix, Arizona, CBOC — Size: 203,000 NUSF. Developer: U.S. Federal Properties Co. LLC; site location: 32nd Street and east Van Buren Street, Phoenix, Arizona
    • Ponce, Puerto Rico, CBOC — Size: 107,388 NUSF. Developer: AJM Management LLC; site location: State Road PR-14 Km. 3.7, Manchuelo Abajo Ward, Ponce, Puerto Rico 00716
    • Redding, California, CBOC — Size: 77,000 NUSF. Developer: SASD Development Group LLC; site location: 3455 Knighton Road, Redding, California 96002
    • San Antonio, Texas, CBOC — Size: 190,800 NUSF.; Developer: U.S. Federal Properties, LLC; site location: East Corner of Rogers Road and Texas Highway 151
    • Tulsa, Oklahoma, CBOC — Size: 140,000 NUSF. Developer: SASD Development Group LLC; site location: 8965 S. Mingo Road, Tulsa, Oklahoma 74133-5716
    • Bakersfield, California — Size: 30,100 NUSF. Developer: SASD Development Group, LLC; site location: Vacant land located along Knudsen Drive, where Oliver Drive and Knudsen Drive intersect; address to be determined.
    VA is committed to delivering these projects as quickly as possible, while continuing to comply with all federal procurement laws and regulations.

    For more information on VA’s leasing business transformation, visit: https://www.va.gov/opa/pressrel/pres...se.cfm?id=4016.



    Courtesy: U.S. Department of Veterans Affairs...
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  • U.S. Department of Health and Human Services Selects Pilot Projects to Demonstrate Better Approach to Disaster Medical Care

    U.S. Department of Health and Human Services Selects Pilot Projects to Demonstrate Better Approach to Disaster Medical Care




    (September 27, 2018) - - Today the U.S. Department of Health and Human Services (HHS) published the following information:

    In a disaster, thousands of Americans may require immediate medical specialty care, surpassing the care available in the community. The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) today awarded two $3 million grants to demonstrate how a new Regional Disaster Health Response System could meet these needs, including trauma, burn or other specialty care, during a national emergency and save more lives.

    “Our nation faces real and serious threats that represent a looming risk to healthcare delivery,” said HHS Assistant Secretary for Preparedness and Response Dr. Robert Kadlec. “This system offers a powerful way to form alliances and build specialized capabilities that save more lives in overwhelming, catastrophic emergencies. The system draws on the existing U.S. healthcare infrastructure, pulling together private sector and federal resources in a way that has never been done. I encourage all healthcare delivery facilities and providers to get involved.”

    Nebraska Medicine in Omaha, Nebraska, and Massachusetts General Hospital in Boston, Massachusetts, received the grants from ASPR’s Hospital Preparedness Program to conduct pilot projects that show the potential effectiveness and viability of a Regional Disaster Health Response System.

    The Regional Disaster Health Response System will build on local health care coalitions and trauma centers, creating a tiered system of disaster care. The system will integrate local medical response capabilities with emergency medical services, burn centers, pediatric hospitals, labs, and outpatient services, to meet the overwhelming health care needs created by disasters.

    More than 31,000 health care organizations participate in health care coalitions nationwide, which are funded by the Hospital Preparedness Program. Coalitions create partnerships among health care facilities and providers in communities, primarily from the private sector, to prepare for disasters and respond.

    In demonstrating a Regional Disaster Health Response System, each pilot project must:
    • build a partnership for disaster health response to support clinical specialty care;
    • align plans, policies, and procedures for clinical excellence in disasters;
    • increase state-wide and regional medical surge capacity;
    • improve state-wide and regional situational awareness, such as the availability of hospital beds; and
    • develop metrics and test the regional system’s capabilities.

    Nebraska Medicine and Massachusetts General Hospital were selected from among 19 applicants nationwide by a panel of experts from professional associations, academia, and federal agencies.



    Courtesy: U.S. Department of Health and Human Services
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  • U.S. Food and Drug Administration’s Center for Devices and Radiological Health on Agency’s Commitment to Studying Breast Implant Safety

    Statement from Binita Ashar, M.D., of the U.S. Food and Drug Administration’s Center for Devices and Radiological Health on Agency’s Commitment to Studying Breast Implant Safety





    (September 14, 2018) - - Today, the U.S. Food and Drug Administration published the following information:

    Choosing to obtain a breast implant, whether for augmentation or reconstruction, is a deeply personal choice, from the initial decision to undergo breast implant surgery to the size, material and surface texture. These types of decisions should be discussed between a patient and their provider in a transparent and balanced way with clear information about the benefits and risks of the breast implants and the procedure.

    As a public health agency, we play an important role in ensuring that patients seeking breast augmentation and breast reconstruction have accurate information regarding the benefits and risks of breast implants to make informed decisions on whether implants may be right for them. Part of this role is to continuously monitor the safety of devices, like implants, once they are being used in patients, including examining adverse event reports that are submitted to the agency as well as reviewing postmarket studies and available scientific literature to enhance our understanding of a device’s benefit-risk profile.

    The FDA has worked extensively to monitor, assess and take action to protect patients with regard to breast implant safety over the last several decades. We have regularly communicated about risks associated with breast implants, such as capsular contracture, implant rupture and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Part of our efforts in continuously monitoring device risks include a responsibility to communicate clearly about our perspective on the safety and efficacy of the products we regulate when new information becomes available. That is why today we’re communicating about the editorial response we published in the Annals of Surgery regarding an external assessment of data that the researchers claim shows evidence of an increased risk of certain connective tissue conditions, such as rheumatoid arthritis and scleroderma, in patients with breast implants. We commend the work of our peers in studying the benefits and risks of breast implants. However, we respectfully disagree with the authors conclusions. In our editorial response, we note our concerns with significant shortcomings with the study’s methodology and how the data is presented and concluded, including inconsistences in the data and potential sources of bias. Because of these concerns, we urge the public and healthcare community to view this external assessment’s conclusions with caution.

    We understand that there are concerned patients with breast implants who are experiencing a range of symptoms that may or may not be related to their breast implants. We take these concerns seriously and are committed to continuing to work with patient groups, surgeons and scientists to further assess this issue. While the agency continues to believe that the weight of the currently available scientific evidence does not conclusively demonstrate an association between breast implants and connective tissue diseases, we respect studies like the ones published in Annals of Surgery by our peers. These studies contribute to our discourse on this topic, but more evaluation is required.

    The FDA has in the past thoroughly assessed and reported the results of the large post-approval studies that were used as a basis for today’s Annals of Surgery study. Our interim and final findings were communicated in a 2011 Safety Update and on the FDA post-approval study websites (for manufacturers Allergan and Mentor) in 2015 and 2018. We noted at the time of the Safety Update that breast implants are not lifetime devices and there is insufficient information to show an association between silicone gel-filled breast implants and connective tissue disease, breast cancer or reproductive problems.

    Our perspective today is based the decades of work we have done to assess and communicate the benefits and risks of breast implants. The steps we’ve taken date back to 1988, when, based on emerging safety concerns, the FDA upclassified breast implants from Class II (moderate risk) to Class III (high risk) devices requiring manufacturers to submit a premarket approval application before the device could be marketed. In 1992, the FDA expressed concern about the available safety data for silicone implants and announced a voluntary moratorium on all silicone implant sales in the U.S. pending further review of safety information. This moratorium was lifted in 2006 with the approval of new silicone implants that met the FDA’s standards for safety. As conditions of approval, each manufacturer was required to conduct six post-approval studies to further characterize the safety and effectiveness of their silicone gel-filled breast implants and to answer additional scientific questions about the long-term safety of breast implants that the premarket clinical trials were not designed to answer. As part of these post-approval studies, the FDA collected data from the studies totaling nearly 100,000 patients. We communicated the results of these post-approval studies in our 2011 report, which noted that that breast implants are not lifetime devices and have a reasonable assurance of safety and effectiveness when used as labeled.

    Also in 2011, the FDA was the first public health agency in the world to communicate about the risks of BIA-ALCL, warning women that the available information at the time indicated that there is a risk for women with breast implants for developing this disease. Since 2011, the FDA has regularly updated the information available on our website regarding known BIA-ALCL cases, including deaths and known risks.

    Collectively, all of our actions demonstrate our commitment to fulfilling our public health mission of ensuring patient access to safe and effective products. As part of our recently released Medical Device Safety Action Plan, we committed to streamlining and modernizing how we implement postmarket actions to address device safety issues to make our responses to risks more timely and effective.

    For instance, we have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry as well as medical literature, meetings with patient advocates, and our own post-approval studies have contributed to our understanding of BIA-ALCL and our communication updates to the public regarding BIA-ALCL.

    Additionally, we are working with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for evaluating real world data on the safety and performance of breast implants that will greatly contribute to helping us evaluate data from providers regarding their patients with implants. We have heard from patients who are concerned that their implants may be connected to other health conditions, like chronic fatigue, cognitive issues and muscle pain. While the FDA does not have evidence suggesting breast implants are associated with these conditions, information from NBIR may help us identify
    ...
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  • U.S. Department of Health and Human Services Secretary Azar Declares Public Health Emergencies in North Carolina and South Carolina Due to Hurricane Florence

    U.S. Department of Health and Human Services Secretary Azar Declares Public Health Emergencies in North Carolina and South Carolina Due to Hurricane Florence





    (September 11, 2018) - - Following the lead of President Trump’s emergency declarations for North Carolina and South Carolina, Health and Human Services (HHS) Secretary Alex M. Azar today declared public health emergencies in the two states as Hurricane Florence continues its track toward the eastern seaboard. The declarations give HHS’ Centers for Medicare & Medicaid Services’ (CMS) beneficiaries and their healthcare providers and suppliers greater flexibility in meeting emergency health needs.






    “Hurricane Florence is an intense storm and is predicted to be highly destructive, which poses a significant threat to the health and safety of those in its path,” Secretary Azar said. “These actions help ensure that Americans who rely on Medicare and Medicaid have continuous access to the care they need when the storm makes landfall.”

    In addition to making these declarations to increase the flexibility in providing services to, and assistance for, CMS beneficiaries, HHS strategically pre-positioned approximately 230 medical personnel from the National Disaster Medical System and their caches of medical equipment in North Carolina and Maryland so these assets are available quickly to help state and local authorities respond to communities’ medical needs. HHS also activated the U.S. Public Health Commissioned Corps’ Rapid Deployment Force to assist if needed after the storm. Additional staff is on standby to assist.

    HHS staff from the Office of the Assistant Secretary for Preparedness and Response (ASPR) also coordinated with the Federal Emergency Management Agency to activate a national contract that makes additional ambulances available to evacuate hospitals and nursing homes if needed. ASPR regional emergency coordinators are staffing operations centers in impacted states to stay abreast of potential public health and medical needs post-storm.

    ASPR and CMS also coordinated to provide information to North Carolina and South Carolina health officials on the number of Medicare beneficiaries who rely on dialysis or on special medical equipment at home and the type of equipment, such as oxygen concentrators, in the potentially impacted areas. With this information, health and emergency management agencies can respond better, particularly after power outages, to save lives.

    Secretary Azar acted under his authority in the Public Health Service Act and Social Security Act in declaring the public health emergency and authorizing flexibilities for CMS beneficiaries. These actions and flexibilities are retroactive to September 7, 2018, in North Carolina, and to September 8, 2018, in South Carolina.

    Public health and safety information for Hurricane Florence can be found on the HHS emergency website, https://www.phe.gov/emergency/events...s/default.aspx




    Courtesy: U.S. Department of Health and Human Services...
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  • U.S. Department of Health and Human Services Secretary Azar Meets with Specialty and Patient Groups Regarding Drug Pricing

    U.S. Department of Health and Human Services Secretary Azar Meets with Specialty and Patient Groups Regarding Drug Pricing






    (August 16, 2018) - - On Wednesday, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar met with representatives of specialty-physician and patient groups to discuss the Trump Administration’s efforts to offer new tools for Medicare Advantage plans to negotiate lower drug prices for patients.

    The groups included the American Academy of Ophthalmology, the American Cancer Society’s Cancer Action Network, the American College of Rheumatology, the American Society of Clinical Oncologists, and Patients for Affordable Drugs. Secretary Azar was joined by Centers for Medicare & Medicaid Services Principal Deputy Administrator Demetrios Kouzoukas, Senior Advisor for Drug Pricing Reform Dan Best, and Advisor to the Secretary John O’Brien.

    Both Secretary Azar and the organizational representatives expressed appreciation for the opportunity to share their views with each other on the recent announcement that Medicare Advantage plans will be able to use step therapy or prior authorization to negotiate lower drug prices for patients. Most of the groups with representatives in attendance have expressed concerns about the new policy.

    Representatives offered their individual views on the new policy, included concerns about the complexity and challenges their organizations’ members have faced in prescribing drugs for patients covered by plans that use prior authorization or step therapy. A number of individuals also expressed their support for the administration’s attention to the issue of prescription drug pricing.

    Secretary Azar emphasized the department’s interest in innovations and solutions that can address the high price of prescription drugs, and individual attendees offered a number of ideas, including noting their support for concepts put forth in President Trump’s American Patients First blueprint. He also shared his openness to solutions that may alleviate the burden that could be imposed on physicians by the new negotiation tools.

    Read the President’s American Patients First blueprint - PDF





    Courtesy: U.S. Department of Health and Human Services...
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  • U.S. Department of Health and Human Services Awards 125 Million Dollars to Support Community Health Center Quality Improvement

    U.S. Department of Health and Human Services Awards $125 Million to Support Community Health Center Quality Improvement




    (August 15, 2018) - - Today, the U.S. Department of Health and Human Services (HHS) announced $125 million in Quality Improvement grant awards to 1,352 community health centers across all U.S. states, territories and the District of Columbia. Funded by the Health Resources and Services Administration (HRSA), health centers will use these funds to continue to improve quality, efficiency, and the effectiveness of healthcare delivery in the communities they serve. This announcement comes during National Health Center Week, the annual celebration that highlights the critical role community health centers play in providing high-quality, affordable, primary healthcare.

    “Community health centers provide coordinated, comprehensive, and patient-centered care to millions of Americans,” said HHS Deputy Secretary Eric Hargan. “They have a track record of delivering quality care at significantly lower cost, and are vital partners in our movement toward a health system that delivers quality, affordable, value-based health care for all Americans.”

    HRSA’s Quality Improvement grant awards promote continued community health center improvements in the following categories: Expanding access to comprehensive care, improving care quality and outcomes, increasing comprehensive care delivery in a cost-effective way, addressing health disparities, advancing the use of health information technology, and delivering patient-centered care.

    Community health centers that exceed national clinical quality benchmarks, like Healthy People 2020 goals, receive special designation as National Quality Leaders. The top 30 percent of community health centers that achieve the best overall clinical performance receive designation as Health Center Quality Leaders.

    “Quality, value-based care is a priority of the U.S. Department of Health and Human Services and HRSA-funded health centers serve as leaders in quality healthcare in the U.S.,” said HRSA Administrator George Sigounas, MS, Ph.D. “Nearly all HRSA-funded health centers demonstrated improvement in one or more clinical quality measures from the year prior, and these funds will support health centers’ work to improve the quality of care they deliver every day in their communities around the country.”

    HRSA also released new data compiled from health centers through its Uniform Data System (UDS) reporting, providing an update on health centers’ provision of primary healthcare services. In 2017, more than 27 million people (approximately 1 in 12 U.S. residents) relied on a HRSA-supported health center for affordable, accessible primary healthcare including:
    • One in nine children 17 years or younger;
    • One in five rural residents;
    • One in three people living in poverty; and
    • More than 355,000 U.S. veterans.
    For more than 50 years, health centers have delivered affordable, accessible, quality, and cost-effective primary healthcare services to patients. Today, nearly 1,400 health centers operate more than 11,000 service delivery sites nationwide.

    For a list of FY 2018 Quality Improvement Awards recipients, visit: https://bphc.hrsa.gov/programopportu...ent/index.html

    To learn more about HRSA’s Health Center Program, visit: http://bphc.hrsa.gov/about .




    Courtesy: U.S. Department of Health and Human Services...
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