Volunteer Responder Incentive Protection Act (VRIPA) Introduced

by: Sendator Benjamin L.Cardin (D - MD

Washington, D.C. - April 23, 2019 - (The Ponder News) -- U.S. Senators Ben Cardin (D-Md.), a member of the Senate Finance Committee, and Susan Collins (R-Maine), the Chair of the Congressional Fire Services Caucus, introduced the Volunteer Responder Incentive Protection Act (VRIPA), bipartisan legislation to enhance communities’ ability to recruit and retain volunteer firefighters and Emergency Medical Services (EMS) personnel.

“Local communities depend on the public service of volunteer firefighters to stay safe and secure. These modest changes will make it easier for communities across Maryland and nationwide to recruit and retain the bravest men and women who are ready to defend against whatever might come next,” said Senator Cardin. “Protecting our communities from harm is one of the most basic functions of government.”

“Across our nation, volunteer firefighters play a critical role in helping to ensure the safety of our communities and the well-being of our neighbors. Maine is largely a rural state, and more than 90 percent of firefighters are volunteers. Without these public-spirited citizens, many smaller communities would be unable to provide firefighting and other emergency services at all,” said Senator Collins. “This bipartisan bill would protect cost-effective incentives that support the brave men and women who volunteer to protect their communities, and I urge our colleagues to join us in supporting the Volunteer Responder Incentive Protection Act.”

“I’d like to thank Senator Cardin for introducing this bill exempting volunteer benefits from being taxed by the federal government,” said Eric Bernard, a volunteer firefighter in Rockville who also serves as the Executive Director of the Montgomery County Volunteer Fire-Rescue Association. “Recruitment and retention of volunteers is a major challenge for fire and EMS agencies in Maryland and across the nation. Passage of the Volunteer Responder Incentive Protection Act will make it easier for communities to offer incentives to their volunteers.”

“Call and volunteer emergency responders are absolutely critical in a predominantly rural state like Maine,” said Ken Desmond, President of the Maine State Federation of Firefighters. “We thank Senator Collins for introducing this important legislation, which will support our efforts to maintain uniform and effective emergency response services throughout the State of Maine.”

In order to bolster recruitment and retention, many fire and EMS agencies now provide benefits, including non-monetary gifts, reductions in property taxes, per-call payments, stipends, or retirement benefits. The Volunteer Responder Incentive Protection Act would allow communities to provide volunteer firefighters and EMS workers with up to $600 per year of property tax reductions or other incentives, without those benefits being subject to federal income tax and withholding. This would ease the administrative burden that local departments sometimes face when they reward their volunteers with minor benefits.

The U.S. Senate Finance Committee has introduced the Retirement Enhancement and Savings Act, which incorporates VRIPA authored by Senators Cardin and Collins.

Click HERE to read the full-text of the bill.

Brown Bill to Crack Down on Drug Company Greed, Protect Taxpayer Dollars Signed into Law

by: Senator Sherrod Brown (D-OH)

Washington, D.C. - April 23, 2019 - (The Ponder News) -- President Trump signed U.S. Senator Sherrod Brown’s (D-OH) bipartisan measure into law that would prevent drug companies from misclassifying their medications as generic drugs to charge Medicaid, and therefore taxpayers, more money. Brown’s measure follows Mylan’s $465 million settlement with the U.S. Department of Justice (DOJ) for overcharging Medicaid by millions of dollars by misclassifying their EpiPen as a generic medication. Brown’s bill would give the U.S. Department of Health and Human Services (HHS) the ability to correctly reclassify a medication and recoup any rebates given to the drug companies when they misclassify a drug. Brown’s measure is part of a bipartisan bill that now heads to the President’s desk to be signed into law.

“Taxpayers should not be on the hook for the drug companies’ corporate greed,” said Brown. “By going after bad actors who try to rig the game in their favor by misclassifying their products, we can cut down on costs and protect Ohio taxpayers who rely on these medications for their health and the health of their families.”

Brown has led the charge when it comes to lowering the cost of prescription drugs for Ohio patients.

Brown recently re-introduced his Stop Price Gouging Act, which would require drug companies to report and justify increases in drug prices, and penalize drug companies that engage in unjustified price increases with financial penalties proportionate to the price spike.

The Stop Price Gouging Act would:

Require drug companies to report increases in drug prices, and justify the increase.

Penalize drug companies that engage in unjustified price increases with financial penalties proportionate to the price spike.

In addition to the Stop Price Gouging Act, Brown also introduced legislation with Rep. Doggett (D-TX) to put people over big Pharma profits. Their Medicare Negotiation and Competitive Licensing Act would authorize the Secretary of Health and Human Services (HHS) to negotiate drug prices and, if drug companies refuse to negotiate in good faith, it would enable the Secretary to issue a competitive, compulsory license to another company that is willing and able to produce the medication as a generic.

Last year, Brown and a group of Senators introduced a package of proposals to help bring down the cost of prescription drugs. The package included provisions to stop price spikes by penalizing pharmaceutical companies that engage in price gouging, and would allow Medicare to negotiate drug prices – which the President promised to do throughout his campaign. Brown’s bill, which will be reintroduced later this year, has been described as “just about every policy idea drug lobbyists hate.”

20th Anniversary of Colombine High School Shooting

by: Senator Michael F. Bennet (D-CO)
April 22, 2019
“Twenty years ago, tragedy struck Columbine High School. Today we remember the 13 innocent victims, their families, and a community determined not to be defined by this senseless act of violence.

“This tragedy opened a troubling new era for our country. Unlike the America I was raised in, we have an entire generation growing up with the fear that they could be a victim of a mass shooting at their school. We cannot accept this as our new normal. As we pay tribute to the lives taken at Columbine we also rededicate ourselves to freeing every American child from the shadow of gun violence.”

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by: Senator Cory Gardner (R-CO)
April 22, 2019
“On the 20th anniversary of the heart wrenching tragedy at Columbine High School we must all remember the friends and loved ones whose lives were taken far too soon,” said Senator Gardner. “As a Coloradan and a father of three I will never forget April 20th, 1999, the day the sanctity of our schools was taken away as parents waited in anguish wondering if their child would make it home. Today is a solemn reminder of the terror unleashed at Columbine High School, and while the years continue to pass since this dreadful day, our state and our country will never forget.”

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Electronic Health Records

by: Senator Lamar Alexander (R-TN)
April 20, 2019
“This proposed rule is an important step toward making it as easy for patients to get their medical records as it is to book an airline flight — and to reduce administrative burdens that are driving doctors away from the practice of medicine. The proposal implements reforms in the 21st Century Cures Act, which Majority Leader Mitch McConnell called the most important new law of the 114th Congress.”

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Senators Blackburn, Tester Ramp Up Oversight of VA’s $16 Billion Electronic Health Record Modernization
by: Senator Marsha Blackburn (R-TN
April 16, 2019
Senators Marsha Blackburn (R-Tenn.) and Jon Tester (D-Mont.) are fighting to keep the VA on target and transparent on its roll-out of the new $16 billion commercial electronic health record system for nine million veterans. The VA is currently undertaking a decade-long transition to bring veterans’ health records into the 21st century by ensuring that veterans can have access to a seamless electronic health record across the VA and Department of Defense health systems. Blackburn and Tester introduced the VA Electronic Health Record Advisory Committee Act to establish a third-party oversight committee to help monitor the implementation of the new electronic health record system.

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UnidosUS: HUD’s Latest Rule Could Impact Millions of U.S. Citizen Children

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by: UnidosUS

Washington, D.C. - April 22, 2019 - (The Ponder News) -- UnidosUS (formerly the National Council of La Raza) issued the following statement in response to the U.S. Department of Housing and Urban Development’s (HUD) proposed rule, which would bar individuals from mixed-status families access to public housing assistance:

“This is really a broader story about how the long-term cost of president’s whimsical immigration policies—here masked under a proposed HUD regulation—will be borne largely by the nearly six million U.S. citizen children that live in a mixed status household. Make no mistake, this is part of an intentionally cruel, misguided and wasteful immigration enforcement strategy hatched by Stephen Miller and his allies. And, it is an effort that is also desperately tone deaf. Our leaders at the highest levels of government should not be engaging in dog whistle politics at a time when there is a real and actionable humanitarian crisis along our southern border that needs to be addressed,” said Carlos Guevara, Senior Policy Advisor at UnidosUS.

UnidosUS, previously known as NCLR (National Council of La Raza), is the nation’s largest Hispanic civil rights and advocacy organization. Through its unique combination of expert research, advocacy, programs, and an Affiliate Network of nearly 300 community-based organizations across the United States and Puerto Rico, UnidosUS simultaneously challenges the social, economic, and political barriers that affect Latinos at the national and local levels. For more than 50 years, UnidosUS has united communities and different groups seeking common ground through collaboration, and that share a desire to make our country stronger.

Decision on Imports of Iranian Oil

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by: U.S. Secretary of State

Washington, D.C. - April 22, 2019 - (The Ponder News) -- Today we are announcing the United States will not issue any additional Significant Reduction Exceptions to existing importers of Iranian oil. The Trump Administration has taken Iran’s oil exports to historic lows, and we are dramatically accelerating our pressure campaign in a calibrated way that meets our national security objectives while maintaining well supplied global oil markets. We stand by our allies and partners as they transition away from Iranian crude to other alternatives. We have had extensive and productive discussions with Saudi Arabia, the United Arab Emirates, and other major producers to ease this transition and ensure sufficient supply. This, in addition to increasing U.S. production, underscores our confidence that energy markets will remain well supplied.

Today’s announcement builds on the already significant successes of our pressure campaign. We will continue to apply maximum pressure on the Iranian regime until its leaders change their destructive behavior, respect the rights of the Iranian people, and return to the negotiating table.

Cotton Statement on U.S. Efforts to End Iranian Oil Exports
by: Senator Tom Cotton (R-AR)
April 22, 2019
"The world pays a steep price for Iranian oil, which funds Iran's military aggression and terrorist proxies. Pressure on the Iranian regime was a necessary decision and I commend the leadership of Secretary Pompeo in the efforts to shift oil reliance from Iran."

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Sen. Cruz: I Applaud President Trump and His Administration for Announcing End of Oil Waivers for Iran
by: Senator Ted Cruz (R - TX)
April 22, 2019
"I applaud President Trump and Secretary of State Pompeo for announcing this morning that the Trump administration will finally end oil waivers for Iran. This decision will deprive the Ayatollahs of billions of dollars that they would have spent undermining the security of the United States and our allies, building up Iran's nuclear and ballistic missile programs, and financing global terrorism. Ending these waivers is another important step in finally ending all American implementation of the Obama Iran nuclear deal, and one that I have longed called for. The administration should also take the long overdue step of ending civil-nuclear waivers, which allow the Iranians to continue nuclear-related work in places like the Fordow centrifuge bunker, which they secretly dug under a mountain so they could build nuclear weapons with additional protection from an aerial attack."

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Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine

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by: U.S. Food and Drug Administration

Washington, D.C. - April 22, 2019 - (The Ponder News) -- The FDA is a public health agency that always strives to use the best available scientific evidence to promote and protect the well being of individuals. It deeply concerns us when we see preventable diseases such as measles or mumps reemerging in the United States and threatening our communities. The World Health Organization recently named vaccine hesitancy one of the top 10 threats to global health. In this time of multiple measles outbreaks, and as we approach National Infant Immunization Week, we want to underscore our continued confidence in the safety and effectiveness of the vaccines that are highly successful at preventing – in some cases, nearly eradicating – preventable diseases.

The MMR vaccine has been approved in the United States for nearly 50 years to prevent measles, mumps and rubella (also known as German Measles). As a result of its use, measles and rubella were completely eradicated in the United States, and mumps cases decreased by 99%. Large well-designed studies have confirmed the safety and effectiveness of the MMR vaccine and have demonstrated that administration of the vaccine is not associated with the development of autism. However we’re seeing an increasing number of outbreaks of measles in communities across the country, including those in New York, New Jersey, Washington, California, and Michigan.

Considered eradicated within the U.S. since 2000, measles has persisted in other areas of the world where the vaccine is not as readily available, including countries in Europe, Asia, the Pacific Islands, and Africa. Unvaccinated U.S. residents may be exposed to measles while they are abroad and bring the disease back into the U.S. and spread it to others. Worldwide, about 20 million people get measles each year. According to the Centers for Disease Control and Prevention (CDC), there have also been outbreaks of mumps reported. It’s an urgent public health priority to monitor these diseases and raise awareness of the importance of timely immunizations, especially as outbreaks are taking hold among unvaccinated populations in this country.

These diseases start with symptoms that may mirror the common cold, but they can cause serious illness and in some cases, even death. Measles – a respiratory disease that causes a skin rash, fever, cough and runny nose – can be dangerous, especially for babies and young children. It is one of the most contagious diseases and can cause severe complications, including pneumonia, swelling of the brain and death. In fact, one to two children out of every 1,000 who contract measles dies from complications of the disease and one in four people who get measles need to be hospitalized. Mumps causes fever, headache, loss of appetite and the well-known sign of swollen cheeks and jaw from the swelling of the salivary glands. Complications, though rare, can include deafness and meningitis (an infection of the lining that surrounds the brain and spinal cord). Rubella, once a common disease that occurred primarily among young children, causes fever, rash, and -- mainly in women -- arthritis. Rubella infection during pregnancy can also lead to birth defects.

We cannot state strongly enough – the overwhelming scientific evidence shows that vaccines are among the most effective and safest interventions to both prevent individual illness and protect public health.

Vaccinating against measles, mumps and rubella not only protects us and our children, it protects people who can’t be vaccinated, including children with compromised immune systems due to illness and its treatment, such as cancer.

We do not take lightly our responsibility to ensure the safety and effectiveness of vaccines, and work diligently to assess safety and effectiveness of all licensed vaccines for their intended uses. The MMR vaccine is very effective at protecting people against measles, mumps, and rubella. It also prevents complications caused by these diseases. And we have nearly 50 years of experience and evidence supporting that fact. In fact, according to the CDC, two doses of the MMR vaccine beginning at 12 months of age (the recommended dosing schedule) are 97% effective against measles, 88% effective against mumps, and 97% effective for rubella.

Like many medical products, the MMR vaccine has known potential side effects that are generally mild and short-lived, such as rash and fever. If parents have concerns about these side effects, we recommend that they speak with their health care providers about the benefits and risks of vaccines, along with the potential consequences of not vaccinating against diseases.

The FDA will continue to closely monitor these outbreaks of vaccine-preventable diseases alongside our federal partners at CDC and the Department of Health and Human Services, and will provide any new information about vaccine safety or effectiveness to the public. But just to be clear, the FDA has determined that the MMR vaccine is both safe and effective in preventing these diseases. We join our colleagues at HHS, CDC, National Institutes of Health and state and local health departments across the country in the continued effort to encourage vaccinations against these preventable diseases.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA permits marketing of first medical device for treatment of ADHD

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by: U.S. Food and Drug Administration

Washington, D.C. - April 22, 2019 - (The Ponder News) -- The U.S. Food and Drug Administration has permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorization by the FDA.

“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”

ADHD is a common disorder that begins in childhood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and very high levels of activity. The diagnosis of ADHD requires a comprehensive evaluation by a health care professional. For a person to receive a diagnosis of ADHD, the symptoms of inattention and/or hyperactivity-impulsivity must be chronic or long-lasting, impair the person’s functioning and cause the person to fall behind normal development for his or her age.

The Monarch eTNS System is intended to be used in the home under the supervision of a caregiver. The cell-phone sized device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient's forehead, just above the eyebrows, and should feel like a tingling sensation on the skin. The system delivers the low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. While the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior.

The stimulation should feel like a tingling sensation on the skin, and the device should be used in the home under the supervision of a caregiver during periods of sleep. Clinical trials suggest that a response to eTNS may take up to 4 weeks to become evident. Patients should consult with their health care professional after four weeks of use to assess treatment effects.

The Monarch eTNS System’s efficacy in treating ADHD was shown in a clinical trial that compared eTNS as the sole treatment, or monotherapy, to a placebo device. A total of 62 children with moderate to severe ADHD were enrolled in the trial and used either the eTNS therapy each night or a placebo device at home for four weeks. The trial's primary endpoint was improvement on a clinician-administered ADHD Rating Scale, ADHD-RS. ADHD-RS scales are used to monitor severity and frequency of ADHD symptoms. A higher score is indicative of worsening symptoms. The ADHD-RS uses questions about the patient’s behavior, such as whether they have difficulty paying attention or regularly interrupt others. The trial showed that subjects using the eTNS device had statistically significant improvement in their ADHD symptoms compared with the placebo group. At the end of week four, the average ADHD-RS score in the active group decreased from 34.1 points at baseline to 23.4 points, versus a decrease from 33.7 to 27.5 points in the placebo group.

The most common side effects observed with eTNS use are: drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events were associated with use of the device.

The Monarch eTNS System should not be used in children under seven years of age. It should not be used in patients with an active implantable pacemaker or with active implantable neurostimulators. Patients with body-worn devices such as insulin pumps should not use this device. The eTNS System should not be used in the presence of radio frequency energy such as magnetic resonance imaging (MRI), because it has not been tested in an MRI machine, or cell phones, because the phone’s low levels of electromagnetic energy may interrupt the therapy.

The FDA reviewed the Monarch eTNS System through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Monarch eTNS System to NeuroSigma.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

VA ensures Veterans have same-day access to emergency mental health care

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by: U.S. Department of Veterans Affairs

Washington, D.C. - April 22, 2019 - (The Ponder News) -- As part of the U.S. Department of Veterans Affairs’ (VA) efforts to provide the best mental health care access possible, VA is reminding Veterans that it offers all Veterans same-day access to emergency mental health care at any VA health care facility across the country.

“Providing same-day 24/7 access to mental health crisis intervention and support for Veterans, service members and their families is our top clinical priority,” said VA Secretary Robert Wilkie. “It’s important that all Veterans, their family and friends know that help is easily available.”

VA’s Office of Mental Health and Suicide Prevention is the national leader in making high-quality mental health care and suicide prevention resources available to Veterans through a full spectrum of outpatient, inpatient and telemental health services.

Additionally, VA has developed the National Strategy for Preventing Veteran Suicide, which reflects the department’s vision for a coordinated effort to prevent suicide among all service members and Veterans. This strategy maintains VA’s focus on high-risk individuals in health care settings, while also adopting a broad public health approach to suicide prevention.

VA has supported numerous Veterans and has the capacity to assist more. In fiscal year (FY) 2018, 1.7 million Veterans received Veterans Health Administration (VHA) mental health services. These patients received more than 84,000 psychiatric hospital stays, about 41,700 residential stays and more than 21 million outpatient encounters.

Nationally, in the first quarter of FY 2019, 90% of new patients completed an appointment in a mental health clinic within 30 days of scheduling an appointment, and 96.8% of established patients completed a mental health appointment within 30 days of the day they requested. For FY 2018, 48% of initial, in-person Primary Care — Mental Health Integration (PC-MHI) encounters were on the same day as the patient’s PC encounter. During the first quarter of FY 2019, 51% of initial, in-person PC-MHI encounters were on the same day as the patient’s PC encounter.

Veterans in crisis – or those concerned about one – should call the Veterans Crisis Line at 800-273-8255 and press 1, send a text message to 838255 or chat online at VeteransCrisisLine.net.

Former Alabama Police Investigator Pleads Guilty to Assaulting Handcuffed Arrestee

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by: U.S Department of Justice

Tallahassee, AL - April 22, 2019 - (The Ponder News) -- The Department of Justice announced today that a former Tallassee Police investigator, Brandon Smirnoff, 27, pleaded guilty to assaulting a handcuffed, 24-year-old man.

According to the guilty plea, Smirnoff, who was on duty as an investigator with the Tallassee Police Department, used his patrol car to pursue the victim, J.M., who was on a four-wheeler. After the pursuit, J.M. stepped off his four-wheeler, laid face down on the ground, and allowed several Tallassee police officers to handcuff him. While J.M. was handcuffed and compliant, Smirnoff lifted him into the air and then slammed him to the ground. Smirnoff then repeated the assault. Moments later, before Smirnoff placed the victim into his patrol car, Smirnoff slammed the victim’s head into the side of the vehicle. For each assault, the victim was handcuffed, compliant, and did not pose a threat.

“Police officers who willfully use excessive force not only violate the Constitution, they erode public trust in law enforcement,” said Assistant Attorney General Eric Dreiband of the Department of Justice’s Civil Rights Division. “The Civil Rights Division is committed to protecting victims of these abuses and upholding the Constitution and laws that protect us all.”

“It is especially important in a climate of distrust between law enforcement and the public, that officers act ethically and within the bounds of the law,” said U.S. Attorney Louis V. Franklin for the Middle District of Alabama. “This police officer’s brutal behavior was unacceptable and criminal. He violated this young man’s constitutional rights and the trust placed in law enforcement officers to faithfully, ethically, and morally enforce the law. You can be sure that anytime an officer steps over the line and into criminal behavior, as this one did, my office will hold that individual accountable.”

FBI Special Agent in Charge James E. Jewell stated, "the FBI supports our state and local law enforcement partners but will not tolerate the intentional abuse of a citizen. The position of police officer should convey compassion as well as trust and we intend to hold that line."

Smirnoff faces a statutory maximum sentence of 10 years in prison and a $250,000 fine.

This case is being investigated by the FBI’s Montgomery Division. It is being prosecuted by Assistant U.S. Attorney Denise Simpson of the Middle District of Alabama and Trial Attorney Michael J. Songer of the Civil Rights Division.