WASHINGTON - Sen. Chuck Grassley of Iowa is asking Northwestern University for documents on a medical device implanted in patients for heart valve repair.  Grassley wrote to the university in 2008 and 2009 about the Myxo device over allegations that the device had not been cleared by the Food and Drug Administration (FDA) before it was implanted in patients as part of an outcomes study.

Since then, new allegations have come to light that Northwestern did not provide all of the documents to Grassley that were squarely within the scope of his request, and that Northwestern failed to provide any notice or explanation of why it was withholding certain documents.  In a letter this week to the presidents of Northwestern University and Northwestern Memorial Hospital, Grassley asks for the documents apparently withheld from him in response to his earlier inquiries.

The documents are important to reviewing whether Northwestern's use of the devices was appropriate and whether notification to patients was adequate.

Grassley has a longstanding interest in FDA oversight and patient safety.

The text of his letter is available here.

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It's a sad but simple fact - patients suffering from life-threatening or chronic illnesses need access to their prescribed medications. How they pay for them, though, is another story.

Despite paying insurance premiums like everyone else month after month, these patients are being forced to pay a much higher percentage of their healthcare costs as insurance companies jack-up the co-payments for more and more medicines, putting an even bigger burden on those who are suffering already.

Unless you are dealing with this, you probably don't even know that insurance companies divide prescriptions into tiers, which typically have fixed co-payments. Many of these companies have added a "specialty tier," which is a fourth category of medicines that requires the patient to pay co-insurance, or a percentage of the drug price.Often, newer, more expensive or more specialized medicines are placed on these specialty tiers and require a sizable out-of-pocket payment by the patient.

Medications needed for life-threatening or debilitating diseases - like oral medicines for cancer or factor for patients suffering from hemophilia - may cost a patient between 25 to 50 percent of the total cost of the drug.

Senator Linda Holmes (D-Aurora) is taking an important step to protect patients across Illinois by introducing Senate Bill 3395 to limit patients' cost-sharing burden, ensuring that any required co-payment to drugs on a specialty tier does not exceed $100 per month.

Joan McGovern, whose husband recently passed away from hemophilia, has first-hand experience worrying about prescription drug costs. Mr. McGovern took Factor 8 for nearly 20 years to manage his disease. Her husband was on Medicare and received full assistance and did not have to pay for Factor 8. If the assistance program did not cover him, he would have had to pay the increased percentage of the co-pay for Factor 8 under the "specialty tiers" category. This would have meant that Mr. McGovern would have had to pay close to $700 every other day for Factor 8 to ensure that he had the life-saving medication he needed to prevent hemorrhaging from his brain and throughout his joints.

Joan also has a 3-year-old grandson who lives with hemophilia. His medication is currently covered by his insurance, but as his condition continues to evolve so will his medical needs. And, sadly, his family will end up having to pay for these exorbitant out-of-pocket costs under the "specialty tiers," which could add up to over $300 per week.

The reality is that most families aren't able to afford expensive medications under these specialty tiers. Patients, who are already suffering, should not have the extra burden of extremely high out-of-pocket costs to manage their illness.

Physician-Chef Points Out the Pros, Cons of 3 Suggested Changes

It's nothing new to the American consumer that food packaging emphasizes only part of a product's health story, and the fact that the nutritional labeling hasn't been overhauled in 20 years hasn't helped, says cardiologist and professional chef Michael S. Fenster, MD.

A proposed update, which could take a year or more to appear on store shelves, is being driven by first lady Michelle Obama, as part of her "Let's Move" campaign.

"Our current nutrition labeling is the same as that implemented in the 1990s, except with the 2006 addition of trans fats information. It's based on nutrition data and eating habits from the 1970s and 1980s," says "Dr. Mike," author of "Eating Well, Living Better: The Grassroots Gourmet Guide to Good Health and Great Food," (www.whatscookingwithdoc.com).

From the perspective of physician and foodie, he analyzes what's good about the first lady's proposed new label, and what could be improved.

• Good: Calorie counts would be displayed in a bigger, bolder font. Emphasizing calories allows consumers to think with a helpful "energy in / energy out" baseline. Do I really need the calories in this product when I could stand to lose a few pounds? That's a reasonably good question to promote.

***Basing the value of food primarily on calories over-simplifies the evaluation process. An energy drink may have zero calories, but it's not better for you than an apple, which may have 100 calories. We cannot overlook nutrition!

• Good: Serving sizes would be determined from real data reflecting the portions real people typically eat. A serving of ice cream is expected to increase from a half cup to a full cup, and a one-serving muffin would be 4 ounces instead of 2 ounces, reflecting the obvious fact that people generally consume the whole scoop of ice cream and the whole muffin.

***Food producers may simply change the size of pre-packaged portions to skirt the rules. Industry experts suggest some food manufacturers may just reduce the package size to make their labeling more seductive. When food is parceled into smaller packages, the price per unit usually increases - it becomes more expensive for consumers.

• Good: New labeling would have listed separately, "added sugar." The grams of sugar added, irrespective of whether it's pure cane sugar, corn syrup, honey, sucrose or any other source, would be shown as one listed value. This is good because it starts to get into the quality and composition of the food product, at least indirectly. Many public health experts say "sweet creep" has been a major contributor to obesity, certain cancers, cardiovascular disease and diabetes.

***This will likely be wildly controversial, prompting aggressive lobbying efforts that may have already begun. The Grocery Manufacturers Association and other industry groups note that the current label already includes the total amount of sugar in the product. The food industry argues that natural sugar and added sugar are chemically identical and that the body doesn't differentiate between the two. However, a significant amount of research shows this is not completely true.

About Michael Fenster, MD

Michael Fenster, M.D., F.A.C.C., FSCA&I, PEMBA, is a board-certified cardiologist and former Assistant Professor of Medicine at the NEOUCOMM. Dr. Mike is a passionate teacher who has addressed numerous professional organizations and he has participated in many clinical trials. He has published original research featured in peer reviewed scientific and medical journals. He worked his way up to executive chef before medical school and later received his culinary degree in gourmet cooking and catering from Ashworth University; where he graduated with honors. He has combined his culinary and medical expertise to deliver delicious cuisine to delivers us from the disability and diseases of modern civilization through his Grassroots Gourmet™ approach to metabolic health.  Dr. Mike's first book  "Eating Well, Living Better: The Grassroots Gourmet Guide to Good Health and Great Food,"  is currently availability. His next book, The Fallacy of the Calorie is slated for release Fall 2014. (www.whatscookingwithdoc.com).

In response to a letter from Loebsack, House Energy and Commerce Committee to hold hearing on propane crisis

Washington, D.C. - Congressman Dave Loebsack today called on Congress to quickly pass legislation to help ease the propane crunch that Iowa and much of the Midwest are currently facing. Loebsack has been leading the charge to figure out the cause of the recent spike in propane costs as well as fighting to find a solution to the problem. This dramatic rise in propane costs has caused significant hardships for families and farmers. A vote on H.R. 4076, the HHEAT Act of 2014, is expected later today (Tuesday) in the House. After its anticipated passage, it will then head to the Senate for consideration. Also, in response to a letter Loebsack and a bipartisan coalition of Midwestern lawmakers sent last month, the House Energy and Commerce Committee has scheduled a hearing this Thursday to look into the current propane shortage.

"The sudden increase in the price of propane, combined with an extremely cold winter continues to wreak havoc on many Iowans' pocketbooks. I am pleased this legislation is moving forward to provide some needed relief for folks who heat their homes with propane," said Loebsack. "This is another expense Iowans cannot afford. I will continue to push this legislation forward until it is signed into law by the President. These barriers must be removed to allow a necessary supply of propane to reach Iowans and help lower the price."

In response to the crisis, Loebsack also joined the Iowa delegation in calling on the Federal Trade Commission to review the spike in propane costs, as well as called on the President to take any necessary action to address the problem.

H.R. 4076, "Home Heating Emergency Assistance Through Transportation Act of 2014" will address the shortages and interruptions in the availability of propane by providing a blanket exemption from federal restrictions on deliveries of propane and other home heating fuels until May 31, 2014, in states where governors have declared emergencies. Doing so would eliminate the need for state governors to renew their emergency declarations.

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1941

The Red Cross began collecting blood for the U.S. military with Dr. Charles Drew as medical director.

1943

March was first proclaimed Red Cross Month by Franklin Roosevelt. Every president since has honored Red Cross Month.

1948

The Red Cross implemented the first nationwide blood program for civilians. The first collection center opened in Rochester, N.Y.

1972

The Red Cross called for a national blood policy, which the federal government set up in 1974, supporting standardized practices.

1992

The Red Cross applied standardized tests to ensure the safety of blood products. Now about a dozen tests are performed on every blood donation.

PEORIA, Ill. (March 3, 2014) – During Red Cross Month, the American Red Cross invites everyone to make a difference in their communities by giving blood, volunteering, taking a class or making a financial donation. Those supporters enable the Red Cross to continue to help people in need like the Roux family.

Jenny Roux's son, Blake, was born with a rare and serious chromosome disorder that causes multiple abnormalities. Jenny and Blake both received two pints of blood the day he was born. For Blake, that marked the first of many transfusions. Jenny said she knew her time with him would be short, but she credits multiple blood transfusions with helping extend his life.

"Without the blood transfusions, I don't know that he would have even had the 10 months we had with him," she said.

At that point Jenny again turned to the Red Cross, and the organization's Service to the Armed Forces program provided emergency communications about Blake's death to her husband, who was deployed to Iraq.

Thanks to everyday heroes, the Red Cross was there for the Roux family in their time of need.

The Red Cross invites the public to discover their inner hero this month. To make an appointment to donate blood or for more information about other ways to get involved with the Red Cross, visit redcrossblood.org or call 1-800-RED CROSS (1-800-733-2767).

Upcoming blood donation opportunities:

Clinton County

March 23 from 8 a.m. to 12 p.m. at Assumption Catholic Church, 147 Broadway St. in Charlotte, Iowa

March 26 from 3:30-7 p.m. at Immanuel Lutheran Church, 1519 S. Washington Blvd. in Camanche, Iowa

Henry County

March 18 from 10 a.m. to 2 p.m. at Kewanee High School, 1211 E. Third St. in Kewanee, Ill.

March 25 from 1-6 p.m. at First United Methodist Church, 214 N. W. Second Ave in Galva, Ill.

March 28 from 9 a.m. to 3 p.m. at Woodhull Alwood High School Student Council, 301 E. Fifth Ave. in Woodhull, Ill.

Mercer County

March 18 from 9 a.m. to 1:30 p.m. at Mercer County High School, 1500 College Ave. in Aledo, Ill.

March 18 from 11:30 a.m. to 5:30 p.m. at VFW Hall, 106 SW Third Ave. in Aledo, Ill.

March 19 from 10 a.m. to 2 p.m. at Aledo Genesis Medical Center, 409 North West Ninth Ave. in Aledo, Ill.

 

Whiteside County

March 19 from 2-6 p.m. at American Red Cross, 112 W. Second St. in Rock Falls, Ill.

March 19 from 3-7 p.m. at Abiding Word Church, 806 E. Lynn Blvd. in Sterling, Ill.

March 20 from 12-6 p.m. at United Methodist Church, 200 W. Lincolnway in Morrison, Ill.

March 25 from 8 a.m. to 1 p.m. at Robert Fulton Community Center, 912 Fourth St. in Fulton, Ill.

March 26 from 10 a.m. to 2 p.m. at American Red Cross, 112 W. Second St. in Rock Falls, Ill.

March 29 from 5:45 a.m. to 12 p.m. at CGH Medical Center, 100 E. LeFevre Road in Sterling, Ill.

March 29 from 7-10:30 a.m. at American Red Cross, 112 W. Second St. in Rock Falls, Ill.

 

How to donate blood

Simply call 1-800-RED CROSS (1-800-733-2767) or visit redcrossblood.org to make an appointment or for more information. All blood types are needed to ensure a reliable supply for patients. A blood donor card or driver's license or two other forms of identification are required at check-in. Individuals who are 17 years of age (16 with parental consent in some states), weigh at least 110 pounds and are in generally good health may be eligible to donate blood. High school students and other donors 18 years of age and younger also have to meet certain height and weight requirements.

 

About the American Red Cross

The American Red Cross shelters, feeds and provides emotional support to victims of disasters; supplies about 40 percent of the nation's blood; teaches skills that save lives; provides international humanitarian aid; and supports military members and their families. The Red Cross is a not-for-profit organization that depends on volunteers and the generosity of the American public to perform its mission. The Red Cross is supported in part through generous financial donations from the United Way. For more information, please visit redcross.org or visit us on Twitter at @RedCross.

 

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The Affordable Care Act made significant cuts to the Medicare Advantage Program.  Late last week, President Obama's administration proposed regulations to implement those cuts.

Americans are learning, over and over again, that the President wasn't being honest when he promised that you could keep the health insurance you had and liked.

In Iowa, we fought hard to have access to Medicare Advantage so that seniors would have more choices and the range of valuable services available to seniors in other parts of the country.  With the payment cut specified as part of the Affordable Care Act, more and more Iowans will find they can't keep the health care coverage they have.

I hear from Iowans every day who have lost their insurance, lost access to their doctors, and have seen their premiums go up because of the Affordable Care Act.  I have serious concerns that because the President insists on barreling ahead with his law rather than coming to Congress to start over again, more Iowans are going to lose access to the services they need.

I am committed to supporting common-sense approaches to reform that provide access to high-quality, low-cost health care.  
By: Jaime Kulaga, Ph.D., LMHC

There's a lot of hype about March MADness, and if you're an NCAA fan (or married to one) you know it well.

But I'd rather think in terms of March Happiness; training mind and body, just as those basketball players train, to remain positive even when faced with stress, sadness and the cyclicality of life. You can create a habit of happiness.

During March Madness, 68 teams in the College Basketball Association compete the national championship. Sixty-eight teams, one month, 12,000 games - or that's what it feels like to me.

All those teams are vying for that one feel-good moment they've worked so hard to achieve. They've dedicated a large portion of their lives to training body and mind, and when the final two teams compete, one team, each team member, and thousands of fans experience fulfillment and happiness.

This March, compete against yourself. Train your mind and body to be healthier and happier than ever before. At this point in the game, you may feel the odds are against you. About 40 percent of people who set New Year's Resolutions have already quit trying. But this month, you are powering up, not gearing down.

You can do it. Here are my TOP 3 Tips for being happy in March and all year long:

Smile and Wave Goodbye to the Toxic People: Waving goodbye has never made you smile so big. In a world where everyone faces uncontrollable stressors and negativity every day (no matter how happy of a person you are), you must get rid of the things and people that are only going to bring you further down. Rid yourself of the toxic people in your life, the haters and the hurters. Take control of your happiness by not allowing others to steer your emotions up and down, or steal them altogether. If you can't completely rid yourself of the negative people, you can definitely set boundaries to minimize your interactions with them. Saying goodbye means saying hello to happiness.

Take Time to Decide: The best way to be unhappy is to go around making promises or commitments you can't live up to or, if you do live up to them, you despise every moment of it. You get one life, so make it a happy one. Don't over commit to someone else and then under commit to yourself. Your happiness is just as important as everyone else's, and don't think otherwise.

When you make an impulsive decision, it is typically based on intense emotions and made with little thought. In most cases, quick decisions are not only poor decisions, they also reduce your control and even ruin your credibility.

To create happiness, make a habit of taking time when making both large and small decisions. Retreat, Rethink, React are your new decision-making steps, in that order.

Forgive: When you hold grudges, possess anger or find yourself always looking backward, it is hard to move forward. The great thing about forgiveness is you don't have to feel it, you just do it. And you are doing it for you, not the other person. If you are angry with someone, your attention and energy is given to them, not you. You can't control your past, and that can be upsetting sometimes. But you can control your future, and you can drive right up to happiness.

As you compete against yourself in March, you must dedicate a portion of your life to training your body and mind. This takes time and commitment. Remember that you are competing for one thing -- that feel-good moment when you notice more days seem brighter; when you notice the win. It not only lies within you, but within your family (team) and all those who you interact with (fans).

This March, turn your Madness into Happiness.

About Jaime Kulaga, Ph.D, LMHC

Jaime Kulaga, Ph.D., LMHC, is the author of "Type 'S'uperWoman - Finding the Work-Life Balance: A Self-Searching Book for Women," (www.mindfulrehab.com). Motivated by watching those she coaches become successful and with a true passion for helping others, Dr. Kulaga earned her bachelor's degree in psychology, and master's and doctorate's in counseling. As a licensed mental health counselor and certified professional coach, she has a special interest in the complex lives of today's women.

WASHINGTON–Provisions within the Affordable Care Act are both boosting the economy and helping millions of Americans receive affordable, quality health care, but adequate oversight is needed for "self-funded" insurance plans, witnesses testified at a Health, Employment, Labor, and Pensions Subcommittee hearing today.

"Of the workers who get coverage through their jobs, about three in five work for an employer who self-funds their coverage, which means that they directly assume responsibility for covering the cost of their employees' medical care," said Rep. Dave Loebsack (D-IA), a senior Democrat on the subcommittee. "While the ACA provides employers who self-fund with greater flexibility, it also ensures that workers with this coverage have access to many of the law's important new consumer protections."

The landmark health care law protects workers in self-insured plans in a variety of ways. It allows, for example, parents to keep their children on their coverage until the age of 26; bans annual and lifetime limits on coverage so that battling a major chronic or catastrophic disease won't lead to bankruptcy; and provides the right to an external review of a benefit denial and the right to a summary of benefits and coverage, which helps ensure insurance decisions are made fairly and empowers those comparing plan options.

Furthermore, the economy has improved since the ACA was enacted. More than 8 million new jobs have been added, and the law is reducing job lock. With increased flexibility in the labor market, workers can make career decisions, such as changing jobs or starting their own business, without worrying about their health insurance coverage.

Employers may benefit from self-funding their health insurance plans. However, there are risks to such insurance models that require sufficient governmental oversight. For example, protections may be needed to ensure that employers don't repeatedly move back and forth between the fully insured and self-insured markets in a way that could raise costs and provide instability for workers. In addition, oversight of the insurance policies that businesses use to protect against occasionally higher costs in self-insured plans, called stop-loss insurance, will help ensure that this market is stable, especially for smaller employers and their employees.

"Ultimately, self-funding will likely lower costs for some employers who choose this path. But this trend will dramatically increase costs for other employers and their employees who remain in the insured market because self-funding is not a viable alternative," said Maura D. Calsyn, Director of Health Policy at the Center for American Progress. "We must acknowledge this and other trade-offs as part of the discussion about self-funding and affordability. Oversight and regulation of stop-loss insurance, which is extremely limited today, will help stabilize the small-group market and protect both employers and employees."

For more information on the hearing, click here.

For more information on the benefits and consumer protections of the Affordable Care Act, click here.

Committee on Education and the Workforce Democrats

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Washington, D.C. - Congressman Dave Loebsack (IA-02), who served as the Senior Democrat on the Health, Employment, Labor, and Pension (HELP) Subcommittee of the House Education and Workforce Committee, today delivered the following opening remarks at the hearing entitled "Providing Access to Affordable, Flexible Health Plans Through Self-Insurance."

Loebsack's opening statement, as prepared for delivery, is below.

"Good morning. I want to thank Chairman Roe for calling today's hearing and thank all of the witnesses for testifying.

"The Affordable Care Act paves the way for all Americans to have access to quality, affordable health care coverage for the first time.

"While it is unacceptable that technical problems prevented people from signing up for the marketplaces at the outset, there is more than a month of open enrollment left and millions of Americans are signing up for coverage.

"As of last month, approximately 4 million people have enrolled in a marketplace plan and millions more have secured coverage through Medicaid.

"The ACA is also helping strengthen employer-sponsored coverage for the more than 150 million workers and their families who get their health insurance through employment.

"Of the workers who get coverage through their jobs, about three in five work for an employer who self-funds their coverage, which means that they directly assume responsibility for covering the cost of their employees' medical care.

"While the ACA provides employers who self-fund with greater flexibility, it also ensures that workers with this coverage have access to many of the law's important new consumer protections.

"Because of the Affordable Care Act's ban on annual and lifetime limits, workers no longer face financial ruin if they confront a chronic or catastrophic illness.

"Children can stay on their parent's plan until they are 26, including 5,400 young people in my district alone. This means that rather than worrying about whether they can afford adequate coverage at the very early stages of their careers, we are giving America's young people a chance to focus on building a strong future right from the start.

"Now workers have the right to appeal a benefit denial to an independent third party and they have the right to a summary of their benefits and coverage to help them compare costs and understand their health care plan.

"The Affordable Care Act also provides workers with greater freedom as they are no longer tied to their employer for their health care coverage. This newfound freedom gives workers greater flexibility in the labor market: they are free to make career decisions, such as changing jobs or starting their own business, without worrying about how they will continue to get health insurance.

"Employers are also benefiting from the law and saving money through such provisions as the small business tax credit and medical loss ratio. In fact, last year health care costs grew at the slowest rate in 50 years.

"Spending less on health care allows employers to create more jobs. Since the law's enactment, more than eight million new jobs have been added to the economy?and nine out of 10 of those jobs are full-time positions.

"Recent reports have indicated that more employers may be looking to self-insure.

"As part of today's hearing, I expect we will discuss the issues unique to the self-insurance market. I think this is an important conversation.

"While there are many benefits to employers who self-insure, there also can be significant financial risk.

"The recent story about AOL exemplifies the risks involved with self-insuring and re-enforces why employers must be adequately prepared if they face higher than expected health care costs.

"The CEO of AOL recently blamed the high health care costs incurred by two babies for the company's decision to cut contributions to its retirement plan.

"With 5,000 workers, AOL is not what I would consider a small employer and thus was ultimately able to absorb the costs.  They did not have to shift the costs onto employees, and, after a public outcry, they backpedaled their plan to cut retirement benefits. A smaller employer?regardless of whether they had stop-loss coverage?may not have as much flexibility to absorb unexpected costs in a self-funded plan.

"I hope today's conversation will be a constructive one and look forward to the testimony. Thank you very much, Mr. Chairman. I yield back."

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