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Researchers Explore Health Effects of E-Cigarettes

It’s not uncommon these days to see people using electronic cigarettes (e-cigarettes) in restaurants, bars and parks, all while huge plumes of aerosol swirl around them. Also known as “vaping,” the use of these  hand-held devices has become common, and some teenagers, according to the CDC and FDA, are their biggest fans: More than 2 million middle and high school students use the products, which come in assorted flavors and forms, from devices that resemble regular cigarettes to those that resemble pens or flash drives.

According to preliminary data from the National Youth Tobacco Survey, the number of high-school age children reporting use of e-cigarettes rose by more than 75 percent from 2017 to 2018; and use among middle-school children increased nearly 50 percent. In a recent Washington Post op-ed, HHS Secretary Alex Azar and FDA Commissioner Scott Gottlieb called this an epidemic.

E-cigarettes are the most commonly used tobacco product among youth in the United States. Given their popularity, health officials see the fast-growing use of e-cigarettes as cause for concern among youth. E-cigarettes come with a small battery that heats a liquid that may contain nicotine, transforming it into an inhalable aerosol. Most liquids also feature flavors, including some kid-friendly flavors like bubblegum, gummy bear, and cotton candy, which can broaden their appeal to youth. 

Yet, while e-cigarettes are less harmful than regular combustible tobacco products—and a possible pathway to tobacco-smoking cessation for adults—the evidence on the effectiveness of these products for helping adult smokers quit completely is still uncertain. Additionally, questions remain about the long-term health impact of e-cigarettes, including respiratory outcomes.  Smoking tobacco, for example, can cause chronic obstructive pulmonary disease, or COPD, the fourth leading cause of death in the United States.  However, it’s uncertain what impact e-cigarette aerosol exposure may have on respiratory health.

Vaping devices
Vaping devices

The Surgeon General has reported that tobacco use among youth and young adults in any form, including e-cigarettes, is not safe. E-cigarette use among children and teenagers may lead to addiction and harm to the developing adolescent brain. Finally, there is a concern that e-cigarette use may lead to future uptake of regular cigarettes among young people.

A broad coalition of agencies and institutes across the Department of Health and Human Services, including the FDA, NIH and CDC, are now working together to explore, in-depth, the health effects of these products. For example, the National Heart, Lung, and Blood Institute (NHLBI) will examine the effects of e-cigarettes on the heart and lungs. The institute has recently awarded 20 research grants in this area in addition to its previously awarded e-cigarette studies; four of those grants were also supported by the FDA. Several other grants in this area have been funded by other NIH institutes such as the National Institute on Drug Abuse and the National Cancer Institute.

In addition to these activities, the Centers for Disease Control and Prevention is at the forefront of population-based surveillance and public messaging on the issue of e-cigarettes among young people, and led the 2016 U.S. Surgeon General’s Report on e-cigarettes, the first report issued by a federal agency that comprehensively reviewed the public health issue of e-cigarettes and their impact on our nation’s youth.

“This has been a fantastic collaboration across HHS,” said Lisa Postow, Ph.D., a project officer in the Airway Biology & Disease Branch in NHLBI’s Division of Lung Diseases.  “We’re excited to play a key role in gathering evidence on the health effects of e-cigarettes that will hopefully inform practice and policy in the future.”

Each of the new NHLBI grants will seek to explore the potential health effects of e-cigarettes. Selected studies include the following:

Characterizing the chemical composition of e-cigarette aerosol:  Researchers know that e-cigarette aerosol contains a complex mixture of chemicals that may include nicotine to flavoring additives, and some unknown components. In addition, the aerosol itself is made up of tiny particles that can be inhaled deep into the lung. Researchers at Battelle Pacific Northwest Laboratories are looking to define what about the aerosol is most harmful to the lungs and how the aerosol may affect lung tissue when inhaled.

Analyzing the impact of e-cigarettes on the lungs of young users:  There is growing evidence that e-cigarette use can be harmful to the lungs, promoting conditions such as chronic bronchitis, and that teens might be particularly susceptible.  Researchers at the University of Kansas Medical Center are studying the effects of the aerosol exposure on airway inflammation and lung dysfunction in young e-cigarette users for a period of at least six months.

Studying the effect of e-cigarettes on the heart: Scientists at Huntington Medical Research Institutes are using rodent models to determine the short- and long-term effects of e-cigarette use on the structure and function of the heart and cardiovascular system. They will compare its effects on young versus old hearts as well as hearts with underlying disease. The researchers hope to determine the comparative safety of e-cigarettes to regular combustible cigarettes.

Measuring blood biomarkers in e-cigarette users to assess heart, lung impacts: Researchers at the University of Wisconsin-Madison are measuring blood biomarkers for cardiovascular and lung diseases in four different user-groups: those who use only e-cigarettes, exclusive combustible cigarette smokers, people who use both cigarettes and e-cigs, and those who don’t smoke or use e-cigarettes. They plan to use these biomarkers to determine the harms and risks among these groups for cardiovascular and lung disease.

The NHLBI and other HHS entities are bringing their resources to bear on such an important public health issue as determining the health consequences of e-cigarette use on our nation’s youth. For additional resources on this topic, please see: About Electronic Cigarettes, CDC; Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS), FDA; and FDA takes new steps to address epidemic of youth e-cigarette use, FDA.

Posted in: Prevention and Wellness, Research
Tagged: tobacco, e-cigarettes, vaping




IHS Announces a New Policy to Expand Access to Medication

The word "recovery" on a long road

American Indian and Alaska Native communities across the country are being impacted by the opioid epidemic. IHS is working in partnership with tribes to prevent opioid misuse, treat addiction, and support recovery. This includes promoting safe and effective therapies to help patients stop the inappropriate use of pain medications.

The Indian Health Service is pleased to announce the release of a new Internet Eligible Controlled Substance Provider Designation policy that is designed to increase access to treatment of opioid use disorder for American Indians and Alaska Natives living in rural or remote areas.

Medication Assisted Treatment is the use of medications, in combination with counseling and behavioral therapies, to provide a comprehensive approach to the treatment of substance use disorders. This is one part of a comprehensive approach to achieving long-term recovery.

To prescribe buprenorphine, a medication used for this treatment, providers must have additional training and special authorization from the Drug Enforcement Agency. It is sometimes difficult in rural and remote locations to access a provider with the necessary training and approval to prescribe buprenorphine in an outpatient or office-based setting. This policy enables IHS, tribal, and urban indian organization health care providers to apply to be designated by IHS as Internet Eligible Controlled Substance Providers, allowing them to prescribe controlled substances for Medication Assisted Treatment through telemedicine. Telemedicine uses electronic communications to connect health care providers and patients for remote clinical appointments, as well as some nonclinical services. IHS has found that telemedicine can be one of the best ways to get health care services where they are needed most.

The Drug Enforcement Administration and the Department of Health and Human Services have recently offered clarification surrounding the requirements of Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which generally requires health care providers to conduct an in-person medical evaluation before prescribing Medication Assisted Treatment through telemedicine. The recent clarification addresses exceptions to this in-person evaluation requirement for patients treated in a DEA-registered facility or in the presence of a DEA-registered practitioner.

The Internet Eligible Controlled Substance Provider exception to the Ryan Haight Act allows IHS-designated providers to prescribe Medication Assisted Treatment over telemedicine when the patient is not in the presence of a DEA-registered practitioner and regardless of DEA facility registration status. This exception will expand access to the full spectrum of treatment options for opioid use disorder to individuals in rural and remote areas. Expanding Medication Assisted Treatment locations will reduce the time for patients to start their recovery journey, potentially lower the risk for return to drug use, and may reduce the potential of death from overdose. An example where this policy exception could be used is in a remote Alaska village clinic that is staffed only by a community health aide.

Please see our website for more information surrounding using medications to support recovery. Additional information surrounding the policy and accessing this exception is available via email.

Posted in: Opioids
Tagged: opioids




Answering Your Questions about the IPI Drug Pricing Model

Last week, as part of fulfilling President Trump’s promise to lower drug prices and cut down on foreign governments’ freeriding, HHS put forth a new way of paying for physician-administered drugs within Medicare, the International Price Index (IPI) Model.

The model aims to:

  1. Reduce the price Medicare pays for a set of costly drugs to closer to what other countries pay.
  2. Remove perverse incentives that encourage the prescribing of more expensive drugs.
  3. Reduce physician burden associated with “buy and bill” by enabling private sector vendors to play a larger role in the purchase and distribution of these drugs.

To help people understand how the IPI model will accomplish these goals, we thought it would be useful to answer some questions that have been asked since the model’s release.

How much money will this save patients and Medicare?

The model is projected to save the Medicare and Medicaid programs more than $17 billion over its first five years, and more than $50 billion in its first eight years.

Because Medicare beneficiaries without other coverage pay 20 percent of physician-administered drug payments as coinsurance, they would see up to $3.4 billion in savings over the first five years. Here are two examples:

  • A senior who receives an eye medicine that currently costs Medicare $1,800 a month, but other countries just $300, would see the coinsurance drop from around $4,400 a year to around $900 a year after full implementation of the proposal.
  • Some Medicare beneficiaries use a drug to fight infection that currently costs Medicare $4,700 every time they receive chemotherapy. On average, it costs other countries $1,100. These beneficiaries would see their coinsurance drop from over $900 every time they use the drug to under $300 after full implementation of the proposal.

How will this model affect patient access? Could this change my Medicare benefits?

The IPI model does not include any restrictions on patient access or choice of drugs. This stands in marked contrast to proposals that would impose formularies in order to negotiate down drug prices. Given the size of the U.S. drug market and the fact that the U.S. will continue to pay 126 percent of what other countries pay, we believe manufacturers will be motivated to support the model.

If HHS believes in this proposal, why is it only being implemented in half the country?

This is a significant shift in how Medicare pays for these expensive drugs, and the administration wants to go about it in a deliberative process, taking into account the concerns of all stakeholders involved.

The size of the model and its gradual schedule for implementation gives manufacturers time to adjust their global pricing strategy as they wish, driving changes to their business model but not on an unrealistic timeframe.

The model is also being rolled out for half of hospitals and physicians, and gradually implemented, so that the various effects of the model —such as on drug prices, quality of care received, and patient adherence to medications—can be monitored and evaluated.

As the model is implemented, there is potential to scale it up further. Moreover, as payments within the model are reduced, the average sales price Medicare pays will drop, reducing what patients outside the model owe.

Is this a free-market model in keeping with the U.S. system that has served patients so well—or is it freeloading off of socialist price-setting systems?

The model replaces an artificially high price point currently used in the program—an average of what all private payers in the U.S. pay for a drug, the average sales price or ASP—with a more rational price point, between that average of private payers and the average of what foreign governments pay for these drugs.

Today, other countries use a variety of means to negotiate down prices, including “reference pricing,” which sets the price a government will pay based on what peer countries pay.

As pointed out in the President’s American Patients First drug-pricing blueprint, when the United States runs a reimbursement system without any meaningful way to obtain discounts on certain drugs, reference-pricing systems can continually drive prices down in other countries while manufacturers’ profits are supported by U.S. prices.

But under the IPI model—which uses other countries’ prices to calculate U.S. prices but does not aim to match them—all wealthy countries would now be using competitive models for pricing this set of costly drugs. The pharmaceutical industry would finally be pressured to fairly allocate the burden of funding innovation across wealthy countries.

The model will also boost free-market competition through its two other prongs: removing incentives created by the current Medicare payment system that encourage prescribing of expensive drugs and removing government barriers that prevent private-sector vendors.

The administration says this is taking advantage of discounts that drug manufacturers voluntarily give to other wealthy countries. Are those discounts really voluntary, or are they essentially mandatory in order to have access to European markets?

Drug companies choose to sell to other wealthy governments at significant discounts in order to take advantage of the volume those payers offer. They have decided this is a workable business model for them.

Under the IPI model, companies will be able to sell drugs to Medicare, a larger payer than any other, at a fraction of the discount they give other countries. This is a voluntary arrangement that would represent a rebalancing of market power between the U.S. and other countries.

Will this proposal harm incentives for investment in innovation?

The best way to support future pharmaceutical innovation is to build a sustainable market-based system for pricing prescription drugs, and that is the goal of this proposal.

While this proposal would aim to cut drug prices in the United States, and pharmaceutical industry profits could be impacted, the pharmaceutical industry has offered no evidence for how $17 billion in savings over five years, representing less than 1 percent of pharmaceutical R&D spending during that time, could have a meaningful effect on innovation. The $17 billion also represents the upper limit for what drug companies may see in decreased revenue in the first five years, because it assumes no change in pricing contracts with other countries.

In fact, bringing more reasonable pricing to physician-administered drugs will help rebalance a distortion created by the fact that Medicare currently overpays for these drugs, while paying more competitive prices for pharmacy-dispensed drugs in Part D—using negotiation tools that industry has resisted in Part B. This may be distorting incentives and encouraging the development of drugs paid for by Part B instead of Part D.

Could this drive up prices for private payers here in the U.S.?

If pharmaceutical companies end up reacting to lower prices in Medicare by pushing up prices elsewhere, commercial payers have negotiation abilities not available within Medicare to push back.

At the same time, pharmaceutical companies are in the driver’s seat when deciding to sell their products at the prices negotiated in foreign markets. The model would encourage manufacturers to cut down on foreign freeriding through higher prices abroad, because pushing up prices abroad will lessen the discounts that pharmaceutical companies will be forced to offer here in the U.S.  This will create a more balanced system of support for innovation

Will doctors and hospitals see cuts to the compensation they receive as add-on payments for administering drugs?

The model will increase the add-on compensation available for provider costs associated with drugs covered by the IPI model, by undoing a cut to compensation that was imposed by budget sequestration (from 6 percent of ASP to 4.3 percent). Further, ASP will still be used to calculate the overall level of add-on compensation available, so physicians would not see compensation cut because they are included in the model where prices are lower.

At the same time, physicians and hospitals would be relieved of the cost and activity involved in buying and holding drugs, which they would now contract out to private vendors.

We are open to comment on the exact details of how to distribute compensation in a way that minimizes disruption while making compensation independent of pricing (for instance, by paying based on overall spending by class of drug or specialty). The aim is to keep physicians and hospitals’ compensation whole while removing any incentives to administer more expensive drugs. For instance, the model would pay the same whether doctors prescribe a branded biologic or a lower-cost biosimilar, allowing patients to benefit from lower drug costs. HHS is eager to engage with providers on how to structure the new compensation system in a way that removes perverse incentives but keeps compensation steady.

Isn’t this going to cut the margins that 340B hospitals receive on drugs they purchase at a discount?

We are aware of the complex interaction between the 340B program and Medicare Part B compensation for drugs. HHS is open to better understanding how hospitals that invest significant resources into serving vulnerable populations could be impacted by the IPI model.

We are interested in comments on appropriate approaches to these addressed concerns. As Secretary Azar has said, HHS will look at how some of the substantial savings generated by the model can be used to ensure that disruption is minimized.

If this model works, why not apply the same thinking to Medicare Part D?

Medicare Part D successfully negotiates deep discounts for pharmacy-dispensed drugs—in some cases, lower prices than are paid by European countries. But Medicare Part B pays significantly higher prices than other countries do for the same set of physician-administered drugs, which is the challenge the IPI model addresses.

The President’s American Patients First blueprint for lowering drug prices and out-of-pocket costs raises the possibility of bringing the successful competitive strategies used by Medicare Part D to negotiate for drugs in Medicare Part B, but these proposals have met with resistance from the drug industry. The IPI model is a more direct approach, which can be implemented administratively, to use a new, international index to recalculate the amount the U.S. pays for these drugs.

The blueprint also lays out other ways to bring lower prices to all parts of the Medicare program, not just through the IPI model but also through new negotiating tools for Medicare Advantage and Medicare Part D.

How does this differ from the Obama administration’s Part B demo in 2016?

The IPI model is intended specifically to avoid some of the problems posed by the 2016 Part B demonstration, by taking a more deliberative approach and aiming to leave both Medicare providers and beneficiaries in a better position financially.

Providers: The IPI model would keep provider compensation steady—and actually undo cuts to compensation imposed by sequestration—while the Part B demo would have cut compensation for many prescribers of expensive drugs, by, in some cases, replacing the 6 percent add-on payment with a 2.5 percent add-on payment and a flat fee. The Part B demo proposed these cuts to physician compensation without addressing the underlying problem of runaway prices for physician-administered drugs.

Beneficiaries: Under the IPI model, as prices are cut, beneficiaries’ cost-sharing for most drugs will be reduced significantly. Under the Part B demo, cost-sharing for a given drug would not have changed significantly, or could have even gone up.

Scale: The Part B demo was also proposed for almost all drugs in Medicare Part B, and the significant majority of providers, while the IPI model would apply only to the most costly drugs with the greatest pricing differences at home and abroad, and to half of providers.

Why would vendors participate? How does the role for vendors in IPI differ from the Competitive Acquisition Program, which almost no vendors joined?

In the 2000s, the Competitive Acquisition Program (CAP) was implemented as an optional program that allowed physicians to buy Part B drugs from a private vendor rather than purchasing and holding the drugs themselves. There are numerous differences between the CAP and the IPI model.

More incentives for participation: Because the CAP was an optional program that removed physicians’ compensation for buying and holding the drugs, there was great uncertainty over whether physicians would participate, which made it an unappealing opportunity for private vendors. Under the IPI model, physicians will still receive an add-on payment even when private vendors take title to drugs.

More flexibility: Further, the CAP did not permit vendors to order drugs as needed, creating great financial risk in ordering drugs. The IPI model would include significant new flexibilities that will make it easier to operate as a vendor.

More choice of vendors: Under the CAP, only specialty pharmacies were allowed to act as vendors, while the IPI model would permit hospitals, physicians, pharmacies, manufacturers, group-purchasing organizations, Part D plans, or other entities to participate.

Shouldn’t something as significant as this go through Congress?

Congress has given the Secretary broad powers to test changes to payment policies within the Medicare program, through the Centers for Medicare and Medicaid Innovation and other means.

The IPI model is put forth through the most transparent means available to HHS—following two RFIs and coming in an Advance Notice of Proposed Rulemaking—and will take the form of a rigorously assessed payment and service-delivery model.

HHS would welcome action from Congress, however, on ideas put forth by the IPI model or other ways to introduce competition to how Medicare pays for physician-administered drugs.

Posted in: Drug Pricing
Tagged: Medicare, prescription drugs




Creating A Foundation for Potential New Kidney Cancer Therapies

In addition to fighting off infections, the human immune system also has the capacity to detect and destroy cancer cells lurking in the body. Cancer immunotherapy involves boosting or refining this response to more effectively treat cancer. There have been many advances in this field, but identifying the patients who would most benefit and understanding how to keep the immune system from over-responding are still areas of active research.

Each year, about 60,000 Americans will be diagnosed with kidney cancer, and 92 percent of them will have clear-cell kidney cancer, in which cancer forms in the small tubules of the kidney. Kidney cancer can often be treated successfully with surgery or radiation in its early stages, and the five-year survival rate for all kidney cancers is 71.2 percent. If the cancer spreads to other parts of the body, the prognosis worsens, and there may be a need for more aggressive treatments, such as immunotherapy. However, it’s estimated that less than 20 percent of patients with clear-cell cancer respond to currently available immunotherapies.

Researchers at the National Institutes of Health have developed a novel immunotherapy approach to treat clear-cell kidney cancer by targeting a protein found only in the cancer cells, and are now testing the approach in a clinical trial. 

The approach leading to this new clinical trial is built on decades of discovery science led by Rear Adm. Richard Childs, M.D., clinical director at the NIH’s National Heart, Lung, and Blood Institute, chief of the Transplantation Immunology Hematology Branch, and an officer in the U.S. Public Health Service Commissioned Corps.

NIH researcher in the lab
Dr. Richard Childs viewing clear-cell kidney cancer sample under the microscope.

Childs’ early work as an NIH fellow spun off the concept of using a bone marrow transplant to treat leukemia and other blood cancers, where immune cells, called T cells, in the donor’s bone marrow are used to destroy leukemia cells in the patient’s body. He hypothesized that this so-called graft-versus-cancer effect could also be effective for treating patients with kidney cancer that had become metastatic – spreading to other parts of the body.

In a pilot clinical trial, Childs’ group found that half of patients who had not responded to other immunotherapies exhibited a graft-versus-cancer response from an immune cell transplant. However, it was not clear which donor T cells were actually killing the cancer, and the transplant also sometimes led to graft-versus-host disease in which the donor cells attack vital organs.

So, Childs and fellow researchers isolated and grew T cells from the blood of a patient whose cancer had regressed after the transplant. From those T cells, Childs’ team then isolated a novel protein on kidney tumors that the T cells were recognizing. That protein was discovered to be made from a piece of viral DNA that lodged itself into the human genome millions of years ago:  called a human endogenous retrovirus (HERV-E). While all people have the HERV-E gene, this gene is only turned on in kidney cancer cells.

The team has now developed a method to genetically modify a patient’s own T cells, thus avoiding the risk of graft-versus-host disease, to specifically recognize the HERV-E antigen to enhance the T cells’ ability to target and kill kidney tumor cells.

A trial is now underway to determine if this strategy is safe. The trial is recruiting 24 adult patients who have clear-cell kidney cancer and who have not responded to other types of immunotherapy or to drugs known as kinase inhibitors that are designed to interrupt tumor growth. To learn about the trial, including detailed eligibility criteria, visit the NIH Clinical Center website.

Posted in: Research
Tagged: cancer, kidney, research




HRSA Celebrates Corps Community Month

NHSC personnel
These NHSC personnel provide health care at a North Carolina health center.

Each October, we celebrate Corps Community Month to honor HRSA’s National Health Service Corps (NHSC) and Nurse Corps clinicians serving communities in need. In my second celebration as HRSA administrator, I'm pleased to recognize the 12,500 NHSC and Nurse Corps clinicians committed to delivering care in rural, urban and tribal communities.

Today, HRSA announced it awarded $293 million to primary care clinicians to care for the underserved through its NHSC and Nurse Corps loan repayment and scholarship programs. An estimated 13 million patients will benefit from these awards.

Patients across the country see NHSC and Nurse Corps clinicians who:

  • Serve on the Front Lines of the Opioid Epidemic – In addition to medical, mental and dental primary care, NHSC and Nurse Corps clinicians also provide opioid and other substance use treatment to their patients. Approximately 3,600 NHSC behavioral health clinicians provide care, which includes medication-assisted treatment and other evidence-based services to address substance use disorder.
  • Improve Access and Healthcare Quality – For 27 million adults and children across the country, federally qualified health centers provide affordable, high-quality and patient-centered primary healthcare that would otherwise be out of their reach. Approximately 63 percent of NHSC clinicians and 1 in 4 Nurse Corps clinicians serve in health centers. We are committed to helping health centers with their workforce planning needs, and the NHSC and Nurse Corps programs are a fundamental part of this support.
  • Work Together – NHSC and Nurse Corps clinicians are part of interprofessional care teams.  We know that multidisciplinary care teams are vital to achieving a comprehensive workforce—a workforce capable of meeting future and current healthcare challenges, like the nation’s opioid crisis.

The NHSC and Nurse Corps awards tackle our nation’s greatest healthcare needs and help provide comprehensive healthcare for patients across the U.S. Please join me in thanking the NHSC and Nurse Corps clinicians for their service during this Corps Community Month!

Learn more about the NHSC and Nurse Corps. Like NHSC and Nurse Corps on Facebook; follow NHSC and Nurse Corps on LinkedIn; follow NHSC on Twitter @NHSCorps; and sign up for HRSA email updates.

 

Posted in: Public Health and Safety
Tagged: National Health Service Corps, Nurse Corps, HRSA awards




Never Miss a Flu Vaccine. Here Are the Reasons #WhyIFightFlu

The reason #WhyIFightFlu? It saves lives.

Americans experienced one of the most severe flu seasons in four decades last year with flu activity remaining high well into March 2018. Millions of Americans became sick with the flu, an estimated 900,000 were hospitalized, and 80,000 died from flu and its complications.

Experts agree that the flu vaccine is the single best way to protect you and your loved ones against the flu. If you are vaccinated, you are less likely to get the flu. And, if you do get sick, studies show that when you are vaccinated, your illness will likely be milder, which helps keep you out of the hospital.

By getting vaccinated, we can prevent the spread of flu to those at greatest risk for becoming dangerously ill, including young children, pregnant women, people 65 and older, and those with certain medical conditions.

Pictures of Admiral Giroir with his granddaughter and getting a flu shot. He's inviting people to share #WhyIFightFlu

To me, this means protecting my mother, my granddaughter and people in my life who have conditions like sickle cell disease or diabetes. But it also means protecting the people I cross paths with every day. The simple act of getting vaccinated helps protect all of these people.

There are so many reasons why everyone should get their annual flu vaccine. Please join me this flu season in sharing the reasons you fight flu each year. Post your reason to your social media with the hashtag #WhyIFightFlu and encourage your family, friends and colleagues to do the same. To help, you can download a #WhyIFightFlu card. To learn more about the flu and find a flu vaccine location near you, use the flu vaccine finder and visit Vaccines.gov.

Posted in: Prevention and Wellness, Public Health and Safety
Tagged: Flu, influenza, vaccination




Witnessing Tribal Health Solutions Firsthand

A key piece to success in serving the American people involves going to them in person and hearing what is important in their lives. That was the reason that a large delegation from HHS recently made the trip to the interior of Alaska. 

Our delegation visited with Alaska Native community leaders and families in Allakaket, Alatna, Hughes, Koyukuk, Manley, Tanana, Rampart, and Fairbanks. Through community meetings and tours of healthcare facilities, we heard about everything from the latest in Telehealth technology and medicine “vending machines” to Head Start and eldercare and the continuing challenges of clean drinking water and waste disposal.

In addition to helping to enhance HHS’s understanding of the challenges faced by remote tribal communities, the tour informed our meeting with the Secretary’s Tribal Advisory Committee (STAC), which convened in Fairbanks on September 24 and 25.   

Deputy Secretary Hargan meets with the Secretary’s Tribal Advisory Committee in Fairbanks, Alaska
Deputy Secretary Hargan meets with the Secretary’s Tribal Advisory Committee in Fairbanks, Alaska

I want to thank Tohono O’odham Nation Tribal leader Chester Antone, chairman of the STAC, and all STAC members for joining us in Fairbanks, and thank Tanana Chiefs Conference (TCC) Victor Joseph, TCC Chief/Chairman, for hosting the HHS delegation from HHS on our tour of interior Alaska. 

During our community visits, it became abundantly clear that the quality of care offered in Alaska Native health facilities should be a point of pride for everyone involved in tribal health.  Alaska Native healthcare providers build on the strengths of tribal culture, customs and community to deliver an impressive whole-of-person approach to care.  Patient needs, community providers, and community leaders are driving the delivery of quality healthcare.

Providing care in rural and remote areas is a challenge—one of the most significant problems American healthcare faces.  The challenges are especially substantial in Alaska, America’s most sparsely populated state, and in other parts of Indian Country.  In Alaska, we got to see a homegrown solution to these challenges, the Alaska Community Health Aide Program.   Community health aides provide access to primary care, preventive services, urgent care and emergency response 24/7, 365 days a year in the most rural and remote areas of Alaska. 

We saw this work in action in Hughes, a community so remote that, as some villages we visited, when you search for directions online, the result is: “We can’t find directions for this journey.” In Hughes, our delegation observed a community health aide use an online diagnostic tool to examine a patient with a rash and then consult with a physician assistant and a pharmacist in Fairbanks, about 250 miles away, on treatment approaches through a two-way internet connection. Medicine to treat the rash was then prescribed in Fairbanks and dispensed through a “vending machine” in the Hughes clinic.  

In Hughes, Alaska a community health aide use an online diagnostic tool to examine a patient with a rash and consult on treatment approaches through a two-way internet connection with a physician assistant and a pharmacist in Fairbanks.
In Hughes, Alaska a community health aide use an online diagnostic tool to examine a patient with a rash and consult on treatment approaches through a two-way internet connection with a physician assistant and a pharmacist in Fairbanks.

Thanks to the advanced systems that Alaska Native communities employ, patient health care information can be instantly transmitted through a shared electronic medical record, telehealth connections, and telephone—no travel needed. 

Deputy Secretary Eric Hargan looks at a medicine "vending machine"
Deputy Secretary Eric Hargan looks at a medicine "vending machine"

Two days later, our delegation visited the Chief Andrew Isaac Health Center in Fairbanks where we witnessed, from the other side of the telehealth connection, the follow-up visit with the patient and community health aide in Hughes.   

In Fairbanks, Alaska the follow-up visit with the patient and community health aide in Hughes.
In Fairbanks, Alaska the follow-up visit with the patient and community health aide in Hughes.

We shared this model of care with the STAC members as an approach one community has developed to providing care in rural and remote locations.  

We also took advantage of our time in Alaska to announce $50 million in new grants to tribes across the nation, through the new Tribal Opioid Response program, to support treatment, prevention, and recovery efforts that combat the opioid crisis.   

Thanks to insights gained in consultation with tribal leaders, these funds were distributed by formula, which allows these dollars to go to the broadest possible set of tribes.

While we were in Fairbanks, we informed leadership from the Fairbanks Native Association and Tanana Chiefs Conference that they would be receiving new grants from the Substance Abuse and Mental Health Services Administration at HHS. 

These community and tribal organizations will be receiving three new awards, totaling $6.2 million over the next few years, to address the opioids epidemic and provide mental health services to youth and young adults.

The trip to Alaska was a significant opportunity to hear about the challenges that rural and tribal communities face in obtaining access to health care, especially when it comes to mental health and substance abuse. Moreover, it was an excellent chance to see solutions to these challenges and highlighted the good work in these communities.

I am grateful to the tribal and village leaders and the many community members who took the time to welcome us into your meeting halls and homes to engage in a dialogue so our HHS team can take back what we learned to Washington.

Posted in: Programs for Families and Children
Tagged: American Indian/Alaska Native, opioids




Self-Sufficiency by Tackling Health and Financial Stability

Consistent with President Trump’s Executive Order on Reducing Poverty in America by Promoting Opportunity and Economic Mobility,  HHS’s Strategic Plan sets goals for HHS to encourage self-sufficiency and personal responsibility, and eliminate barriers to economic opportunity (Objective 3.1) and to support strong families and healthy marriage, and prepare children and youth for healthy, productive lives (Objective 3.3). This blog is part of the Self-Sufficiency Series: Solutions from the Field, which profiles local programs from across the country finding solutions to accomplish these goals.

Collaborations across the nation receive support from the Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV) of HHS’s Health Resources and Services Administration (HRSA). The various initiatives aim to meet the department’s Strategic Plan goals to encourage self-sufficiency and personal responsibility, while improving health outcomes for individuals like Dianna Tolentino, and her husband Luis. 

These two Indiana residents were expecting their first child, and were just getting by, both working low-level jobs at fast food restaurants. But a referral by her doctor to the Nurse-Family Partnership (NFP) has changed the course of her family’s future. NFP and Goodwill of Central and Southern Indiana have joined hands to improve the health of low-income, first-time mothers and their babies and to strengthen the economic stability of their families. 

This particular MIECHV-funded program, Goodwill NFP, is one of many efforts across the nation that receives support from MIECHV. The various initiatives aim to meet the department’s Strategic Plan goals to encourage self-sufficiency and personal responsibility, while improving health outcomes. NFP is a national program that has a presence in 42 states and currently serves more than 34,000 families. Goodwill implements the Goodwill NFP program in 30 counties in Indiana.

Under this particular MIECHV-funded program, Goodwill NFP focuses on education and employment. Moms—and dads—lacking high school diplomas can enroll in one of Goodwill’s adult tuition-free high schools—The Excel Center and receive support through with tutors, child care, internships and life coaches, all at no cost. Goodwill’s in-house TalentSource is available to help program participants find higher-wage jobs.

HHS has set a goal to prepare children for healthy, productive lives, and programs like this contribute to this goal. “Education is one of the biggest social determinants of stability and good health,” said Betsy Delgado, vice president, mission and education initiatives, of Goodwill of Central and Southern Indiana, who told me, “We know children will do better if they are children of solid families.”

Tolentino Family: Goodwill NFP graduate Dianna with husband Luis, son Drakeo and daughter Rain.
Tolentino Family: Goodwill NFP graduate Dianna with husband Luis, son Drakeo and daughter Rain. Photo courtesy of Goodwill

Under this MIECHV-funded program, Goodwill NFP also pairs first-time mothers-to-be with a nurse who visits them at their home and tracks their health and their child’s development to the age of 2. Abby O’Connor, an RN who was Dianna’s nurse, monitored her vital signs, made sure she made her pre-natal care appointments, advised her on baby care, and generally taught her how to  have a healthy pregnancy. Dianna and Abby told me that they talked a lot about Dianna’s goals for herself and her family.  Fathers and other family members can also participate, if the mother wants them to. Abby said Luis became involved in the home visits and attended The Excel Center, earning his high school diploma and a clinical medical assistant certification.

“Our nurses become a big part of a support system that young, first-time mothers often don’t have,” Abby said. “We help moms be their best self.” 

According to Goodwill, only 45 percent of the participants were working before joining the program, while more than 68 percent were working by the time their child had turned 2 years old. Last year, within a year of enrollment, 66 percent of households had an increase in income and benefits. Goodwill program data also show that in 2017, 91.3 percent of the moms who participated in the initiative delivered full-term; 89.5 percent of the babies had a normal birth weight and nearly 100 percent of the women quit or reduced tobacco use before their child’s birth.  Goodwill NFP said these outcomes help set children up for healthy lives, as HHS works every day to do.

Dianna credits Abby’s care and their close relationship with her successful pregnancy. When Abby suspected complications, she made sure Dianna went to her doctor, who determined that she had a condition that would lead to a significantly early delivery, and without medical intervention would endanger both mother and baby.

They now have a healthy daughter and son. And Dianna credits Goodwill NFP for helping her family become more financially stable. Dianna said she now has a job in administration at The Excel Center and is working with a Goodwill coach to increase her financial literacy. “I have no credit history and I didn’t know how to budget,” she explained. Luis has the option of using his certification for a job at a hospital, but he’s working as a chef, which is his long-term goal, Dianna said.

Every day, MIECHV-funded programs help couples like Dianna and Luis move toward self-sufficient and healthy families.

“Without this help [from Goodwill and NFP], it would have been rough. There was not much wiggle room in our lives,” Dianna said. “I look back and can’t imagine how different our lives would have been without NFP and Goodwill. It’s moved us from barely scraping by to becoming a thriving family.”

This effort is just one of countless examples of MIECHV-funded programs across the country working to eliminate barriers to economic opportunity and prepare children for healthy, productive lives. HRSA announced on September 27 approximately $361 million in funding to Indiana and 55 other states, territories and nonprofit organizations through the MIECHV Program. These funds support communities providing voluntary, evidence-based home visiting services to women during pregnancy and to parents with young children up to kindergarten entry.

Goodwill NFP offers prenatal care and counseling for expecting mothers, as well as education, career training and job placement

Posted in: Programs for Families and Children
Tagged: self-sufficiency, Maternal and child health




Community Health Centers Are Fighting on the Front Lines

I met a woman recently, at a community health center in Washington, D.C., whose story, like so many others, highlights how the right supports can help Americans struggling with opioid addiction get back on their feet and to be healthy again.

She was dependent on opioids and had gotten sick and could not work, so she lost her job and then her housing. She thought the world was gone for her, but then she walked into the health center.

The staff took care of her, and a physician got her into a substance abuse program.

She did so well, the center gave her an opportunity to work there as a peer support specialist working with patients who had the same problems with substance addiction.

She was a reborn person. “If I did it, anybody can do it,” she said.

I met another woman who had been suicidal, without hope—until she walked through the doors of a health center in New Hampshire. She also got help for her substance use disorder, and the center’s community partners helped her get employment and housing.

The nation’s 1,400 community health centers, operating over 11,000 clinical sites, are a remarkable partnership between the federal government and the private sector. They know the health needs of their communities best. And no matter who walks through the door, they will be seen and cared for, regardless of their ability to pay.

These centers, supported by the Health Resources and Services Administration at HHS, have a long tradition of providing healthcare to our most vulnerable neighbors. But today, they are also on the front lines of the opioid epidemic that is ravaging so many communities. They play an important role in supporting uninsured and under-insured people with substance use disorders.

These centers were established as primary care centers, but the needs of the people and the communities are always changing and expanding. Substance abuse is a huge problem for the entire nation.

I’ve spoken with many providers at community health centers, and they’re very excited about being able to provide care for people struggling with opioid addiction and other substance use disorders.

At first, they were hesitant because they didn’t think they had enough resources to do the job right, and because they feared the centers might suffer from a stigma related to drug addiction. What I heard was “We are a family-oriented primary care center. What will happen if people know we’re dealing with substance abuse?”

But one of the main focuses of the nation’s fight against the opioid crisis is to fight the stigma that keeps people from seeking treatment, and health centers and community providers understand that as well as anyone. Everybody’s talking about the opioid epidemic now and the need to face it head on.

We’re not sweeping it under the rug. We know that it doesn’t matter the location, the economic status of the patient, the age, the gender—everybody’s affected.

HRSA has been increasing support to the centers to help them integrate mental health and behavioral health with primary care. Last year, HRSA awarded $200 million to health centers to increase access to substance use disorder services. This week, we awarded nearly $400 million to health centers, especially to rural centers, to increase access to and improve the quality of substance use disorder services.

Today, more than 90 percent of centers provide mental health services, and more than 70 percent provide substance use disorder services.

The new grants include $352 million to expand access to substance use disorder and mental health services to more than 1,200 health centers across the nation, to help them implement and advance evidence-based strategies that best meet the needs of their communities. Another $18.5 million is being awarded to support partnerships between 21 academic institutions and 54 health centers to increase the number of professionals and paraprofessionals with real-life training to deliver integrated behavioral health and primary care services in communities with high rates of opioid addiction and overdose.

HRSA is also investing millions of dollars in rural organizations to develop and implement innovative, evidence-based strategies to increase access to substance addiction prevention and treatment services to rural populations that have been disproportionately impacted by the opioid epidemic and face special challenges compared with individuals in urban areas. 

We’re trying to be more innovative so we can reach more people who have no easy access to care for behavioral health, mental health, and substance use disorders.

This is not simply a one-year initiative. We’ll continue the support; we’re not stopping here. Our focus, community health centers’ focus, is to reach out to people—and we’ll continue supporting everyone in need until we have defeated our country’s addiction crisis.

Posted in: Mental Health and Substance Abuse, Opioids
Tagged: opioids, mental health, substance abuse




Healing and Hope for Children After a Hurricane

After a year of working to keep children safe and healthy after Hurricane Maria, educators, social workers and pediatricians are seeing some rays of hope for the children of Puerto Rico and gaining valuable lessons that can be shared to help those affected by Hurricane Florence in the Carolinas or by other disasters this year.

The Office of the Assistant Secretary for Preparedness and Response (ASPR) has spent the last year working with partners from across Puerto Rico, the Centers for Disease Control and Prevention, other HHS divisions, and other federal agencies to strengthen health and social services as organizations recover from Maria and build new plans so they are ready for the next disaster.

In the weeks and months following Hurricane Maria, educators, social workers and pediatricians faced a series of daunting health crises as they scrambled to find ways to help keep the children who rely on them safe and healthy. When school resumed, teachers and administrators were called on to help traumatized students cope, work in buildings damaged by floodwaters and filled with mold, and deal with many more problems. When vaccines were needed, pediatricians did not have reliable access to them.

The scope of the health problems that face the children of Puerto Rico has been staggering, but ASPR is continuing to work with its partners to help education and healthcare providers recover from Hurricane Maria and prepare for the next disaster.

When a disaster strikes, young children are some of the most vulnerable people in a community. Many children rely on child care and early childhood education programs, including Head Start.

Medical responders from the National Disaster Medical System went door-to-door in Puerto Rican communities to assist adults and children who needed medical care in the weeks following Hurricane Maria.

ASPR worked with its partners to enhance the preparedness of child care centers and Head Start facilities by providing emergency preparedness workshops across Puerto Rico. The workshops used an innovative approach to developing emergency operations plans and recovery plans. The approach went beyond the typical facility planning by integrating business continuity planning, training and emergency exercises. This turned out to be a useful model for other communities, territories and states to follow.

For older children, we focused on Puerto Rico’s schools, which are responsible for educating and providing food, shelter and a safe environment to more than 350,000 students. Over the last year, many of these children have lost their homes or returned to a home that was damaged, and many families are still trying to recover.

ASPR has supported training for more than 800 school principals in emergency preparedness, behavioral health interventions, and public health risks so they are better able to care for the students who need help now and they can be better prepared for the next disaster.

In addition, more than 2,000 teachers and social workers were trained to administer psychological first aid, an evidence-informed, modular approach to help children, adolescents, adults and families in the aftermath of disaster. Through this course, the teachers and social workers learned how to spot the signs of stress in children and how to help them cope.

Even in a healthy environment, vaccines are critical for pediatric health. But when a disaster strikes, incidents of vaccine-preventable diseases rise, something that we’re currently concerned about in the aftermath of the storm in the Carolinas.

CDC, ASPR, and the CDC Foundation worked with the Puerto Rico Department of Health Immunization Program to conduct assessments and restore services for the 224 Vaccine for Children (VFC) providers across the island. In March 2018, only 65 percent of these providers were operational and able to order vaccines. In April, that number increased to 86 percent of VFC providers, for a total of 192 providers participating in the program.

As the Carolinas begin the process of recovery, Puerto Rico and U.S. Virgin Islands continue to recover from one of the most devastating and costly hurricanes in U.S. history. The road to recovery is almost always long. HHS is committed to helping the people impacted by disasters recover, especially children and other vulnerable populations. While we assist with recovery, we also continue to help our partners put systems and plans in place that protect health and save lives when the next disaster strikes.

Posted in: Emergency Preparedness and Response, Prevention and Wellness
Tagged: Hurricanes, children, hurricane preparedness




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