WASHINGTON - Sen. Chuck Grassley today urged a key federal agency not to dilute a long-awaited transparency rule that would help disclose financial ties between medical researchers who receive billions of dollars in federal funding and the pharmaceutical industry.

"The public's business ought to be public," Grassley said.  "Transparency is a backstop against research that's compromised by doctors' self-interest, to the detriment of consumers.  Backsliding on transparency would undermine the good work done in recent years to shine a light on these financial relationships."

Grassley wrote to the Office of Management and Budget in response to a media report that the agency is proposing to weaken transparency rules proposed in May 2010 by the Department of Health and Human Services.  According to the article, the Office of Management and Budget is removing the requirement in the proposed rule for a publicly available website that would publish the outside financial interests of researchers funded by taxpayers. 

The Department of Health and Human Services includes the National Institutes of Health (NIH), which is the primary means of federal funding of medical research at universities and large medical centers.  The President's proposed budget for the National Institutes of Health for 2012 is $32 billion, with about 83 percent dedicated for research around the country.

In 2007, Grassley began looking into whether universities have disclosed their professors' outside financial interests and found several cases indicating that more transparency might be helpful, including:

--The chair of the Psychiatry Department at Emory University failed to report hundreds of thousands of dollars in payments from a pharmaceutical company while researching that same company's drugs with an NIH grant.  The Health and Human Services Office of the Inspector General is now investigating the matter.

--The chair of the Psychiatry Department at Stanford University received an NIH grant to study a drug while partially owning a company that was seeking Food and Drug Administration approval of said drug.  He was later removed from the grant.

--Three psychiatrists at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants.  Harvard released a report on the matter, and a briefing has been scheduled with Grassley's office.

Also, the Inspector General for the Department of Health and Human Services concluded that the NIH doesn't adequately monitor its outside grants for conflicts of interest.

A law enacted last year through Grassley and Sen. Herb Kohl will require public disclosure of drug company and medical device manufacturer payments to doctors, starting in March 2013. 

The rule proposed for NIH grants would require the research institutions to determine potential conflicts of interest grant by grant, such as whether the doctor owns shares in a company that could cause bias in his or her federally funded research.  The details would have to be posted online for public access. The Office of Management and Budget is proposing to eliminate the online requirement, according to a media article. 

"If the online requirement is gone, it will be much harder for the public to see and use this information," Grassley said. "Without public scrutiny, we'd lose a valuable layer of oversight."

The text of Grassley's letter is available here.

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MILWAUKEE, WI - Traveling can be exciting and a chance to get away from the hustle of the real world, but it also can derail a person's healthy routines.  People may become relaxed with their nutrition selections or think that it's too much effort to exercise.  With numerous opportunities to travel - whether for business, family vacations, or weekend getaways - TOPS Club, Inc. (Take Off Pounds Sensibly), the nonprofit weight-loss support organization, along with the Produce for Better Health Foundation, shares hints to help stay on the wellness track, cut out calories, and feel satisfied.

Eat healthy on the move.
• Bring your own meal for the flight or car ride.  Homemade sandwiches and fresh fruit are a great option.  Not only will you be able to control what you eat, but you will also save time and money.
• Pick up prepackaged fruit and vegetables at the grocery store.  You can also buy peanut butter in a tube or small container to pair with fruit or granola bars.

Be smart with snacks.
• Have a sweet tooth?  Keep dried fruit, which provides disease-fighting antioxidants, handy for snacking instead of candy.  It can also be mixed with nuts and sunflower seeds to create trail mix.
• Pack peppers, celery, or carrots to snack on during a trip.  Resealable containers are perfect for dips, such as ranch dressing, peanut butter, or hummus.
• Frozen grapes make great bite-size snacks and are delicious with low-fat cheese.

Eat out without overdoing it.
• Do your research.  Check out your destination online and look at restaurant menus before the trip.  This will give you an opportunity to find places that serve healthy options.
• Practice eating small portions.  Bring half the meal home or share an entrée with a friend.  Consider choosing two appetizers instead of one entrée.

Give thought to your drinks.
• Switch from soda to low-fat milk, water, or tea with one sugar or a non-nutritive sweetener.
• Opt for tomato juice or vegetable juice on the plane.
• Out for coffee or a smoothie?  Order the smallest size available, request coffee with fat-free or low-fat milk, skip the whipped cream, ask that the smoothie be prepared without added sugar, and look at nutrition facts, if possible.

Watch portions sizes, but don't deprive yourself.
• Use the half-plate rule.  Make fruits and vegetables 50 percent of what you eat at every meal.
• Don't skip your favorite dessert or fried foods.  Eat smaller portions of these foods - just make it a treat, not a regular occurrence. 
• Don't cut out meals.  This may lead to eating too much later in the day.

TOPS Club Inc. (Take Off Pounds Sensibly), the original, nonprofit weight-loss support and wellness education organization, was established more than 63 years ago to champion weight-loss support and success.  Founded and headquartered in Milwaukee, Wisconsin, TOPS promotes successful, affordable weight management with a philosophy that combines healthy eating, regular exercise, wellness information, and support from others at weekly chapter meetings. TOPS has about 170,000 members in nearly 10,000 chapters throughout the United States and Canada.

Visitors are welcome to attend their first TOPS meeting free of charge. To find a local chapter, view www.tops.org or call (800) 932-8677.

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New Law Ensures Injured Student-Athletes Do Not Return to Play Without Medical Clearance and Increases Critical Head Injury Education

CHICAGO - JULY 28, 2011. Governor Pat Quinn today signed comprehensive legislation that will help protect Illinois' student-athletes from concussions and other brain injuries. The new law ensures that athletes who receive a concussion will not be allowed to return to play or practice until they are evaluated and receive written clearance from a licensed health professional. Additionally, the law ensures that student-athletes, their parents and their coaches are able to recognize the signs of a concussion.

"The desire to compete must never trump the safety of our student athletes," Governor Quinn said. "This new law will ensure that student-athletes, parents and coaches recognize the symptoms and understand the risks of concussions, so that they can prevent a more serious, lasting injury."

House Bill 200, sponsored by Illinois House Minority Leader Tom Cross (R-Oswego) and Sen. Kwame Raoul (D-Chicago), requires each school board in Illinois to adopt a concussion policy that complies with Illinois High School Association (IHSA) guidelines. Those guidelines prevent students who are removed from a game or practice due to a possible head injury from returning without being evaluated and cleared by a medical professional. 

The new law also requires all school boards in the state to partner with the IHSA to develop clear guidelines and materials to educate coaches, student athletes and their parents about concussions. In addition, the bill encourages park districts to educate about the dangers of concussions. 

"I am so thankful to the many groups, athletes and parents who came together to help this bill get to the point where it is being signed today by the Governor," said Rep. Cross. "We are hopeful that this new law will raise awareness for our youth in Illinois when it comes to these devastating and sometimes fatal head injuries."

"We have seen too many disturbing stories about the long-term negative impact of concussions," said Sen. Raoul. "From junior football to youth hockey, from girls' basketball or soccer to gymnastics, this new law will help make sure that young athletes are better protected from potentially life-altering head injuries."

CDC research indicates that sports are the second-leading cause of brain injury in young adults 15-24, and that more than 40 percent of high school athletes returned to play before fully recovering from a concussion. Former Chicago Bears guard Kurt Becker, a member of the 1985 championship team and proponent of the legislation, testified before an Illinois House of Representatives' committee on the effects of head injuries that can last a lifetime. Concussion, defined as a type of traumatic brain injury that interferes with normal function of the brain, creates long-term detrimental health effects that are especially harmful for teenagers.

House Bill 200 goes into effect immediately and has already begun to generate results. Chicago Public Schools has distributed concussion awareness materials to all CPS schools and begun to hold meetings with the IHSA to discuss next steps for implementation. 

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New Law Requires Equal Insurance Coverage for Oral Chemotherapy

CHICAGO - July 27, 2011. Governor Pat Quinn today signed legislation to ensure health insurance benefit equality between oral and injectable cancer drugs, allowing cancer patients more affordable treatment options and protecting them from significantly high out-of-pocket costs. House Bill 1825 requires private health insurance plans that provide coverage for oral and intravenous chemotherapy to cover both at the same benefit level.

"Patients battling cancer shouldn't have to forgo potentially life-savings treatments because of costs," Governor Quinn said. "This legislation will provide more affordable coverage options, so that patients can choose the best, most appropriate therapy to fight their cancer."

Historically, chemotherapy drugs have been primarily administered intravenously. Today, many types of chemotherapy can be taken via a liquid, tablet or capsule, a less invasive therapy alternative. Oral chemotherapy is the only appropriate treatment for certain types of cancer, and can also provide an alternative for patients who have trouble responding to other treatments.

Many healthcare benefit plans have not changed to ensure patient access to oral chemotherapy, resulting in some cancer patients facing higher out-of-pocket costs simply because their treatment is dispensed orally rather than intravenously.

The disparity in coverage for oral treatments is also a factor in deployment of "smart drugs" in cancer treatment. Traditional radiation and chemotherapy are effective in killing cancerous cells, but also kill many healthy cells, weakening a patient's immune system. Smart drugs are delivered orally and designed to navigate the bloodstream with precision to stop the growth of cancer cells, often avoiding damage to healthy cells. While these regimens are often more costly up front, they may be able to significantly decrease the amount of therapy time, increase positive outcomes and reduce longer-term costs associated with traditional intravenous treatments.

Illinois joins a number of states that have enacted cancer drug parity laws including Connecticut, Colorado, Indiana, Iowa, Hawaii, Kansas, Minnesota, Oregon, Vermont, the District of Columbia, and New Mexico. Medicare recipients also receive this benefit for identical oral and intravenous chemotherapy drugs.

Sponsored by Rep. Ann Williams (D-Chicago) and Sen. Heather Steans (D-Chicago), HB 1825 passed the General Assembly unanimously and takes effect Jan. 1.

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Friday, July 22, 2011

For your information, a copy of the letter sent today from the U.S. Center for Medicare and Medicaid Services to the Iowa Insurance Commissioner is attached.

As described in the letter, the federal government has approved Iowa's request for a waiver from the medical loss ratio requirements of the Affordable Care Act of 2010.

The new health care law basically requires states to change the requirement of plans in their states to spend more money on care and less on administration and reserves.  As a practical matter, it could run small carriers out of the state.  The potential market disruption has led a number of states to seek waivers of the medical loss ratio requirement until 2014.  Maine and New Hampshire already have waivers.  Today North Dakota was turned down.  Kentucky was effectively turned down, as well.  Iowa was partially approved.

Here is a comment from Sen. Grassley:

"The purpose of this waiver is to allow Iowa to have different medical loss ratios for insurers than would have been required under the health care overhaul enacted last year.  Without this waiver, because of the mandates in the new law, insurers likely would have left the state, leaving Iowans with fewer health coverage options.  The need for this kind of waiver emphasizes that it should be up to states to regulate their insurance markets.  The 2010 health care needs to be repealed and replaced with policies that allow coverage that fits the needs of different marketplaces."

Here is a fact sheet from the Centers for Medicare and Medicaid Services:

Medical Loss Ratio: Getting Your Money's Worth on Health Insurance

 Thanks to the Affordable Care Act, consumers will receive more value for their premium dollars because insurance companies are required to spend 80-to-85% of premium dollars on medical care and health care quality improvement, rather than on overhead costs. If they don't, the insurance companies will be required to provide a rebate to their customers starting in 2012. This policy is known as the "medical loss ratio" (MLR) provision of the Affordable Care Act.

Medical loss ratios apply to all health insurance plans, including job-based coverage and coverage sold in the individual market. However, insurance plans in the individual market often spend a larger percent of premiums on administrative expenses and non-health related costs than job-based health plans do.

Recognizing the variation in local insurance markets, the Affordable Care Act allows States to request a temporary adjustment in the MLR ratio for up to three years, to avoid disruptions to coverage in the individual market. This flexibility allows consumers to maintain the choices currently available to them in their State while transitioning to a new marketplace where they will have more options for coverage and more affordable health insurance through State-based Health Insurance Exchanges. This is one of many ways the Affordable Care Act is building a bridge from today's often disjointed and dysfunctional markets to a better health care system.

HHS has set up a transparent process for how States can apply for an MLR adjustment and what criteria will be used to determine whether to grant those requests. States must provide information to the Department of Health and Human Services (HHS) showing that requiring insurers in their individual market to spend at least 80 percent of their premiums on medical care and quality improvement may cause one or more insurers to leave the market, reducing access to coverage for consumers. States must also show the number of consumers likely to be affected if an adjustment is not granted and the potential impact on premiums charged, benefits provided, and enrollee cost-sharing. All State application materials are posted on the HHS website.

The Iowa MLR Adjustment

Iowa's Department of Insurance requested an adjustment of the 80 percent MLR to a 60% MLR standard for 2011, 70% for 2012, and 75% for 2013. 

Three of Iowa's dominant issuers, Wellmark, Time and American Family -with 88% of Iowa's individual market share- are not expected to be impacted by the 80% MLR standard.  Wellmark and American Family both had a 2010 MLR of well above 80% and while Time had a 2010 MLR below 80%, it does not expect to owe rebates in 2011 or beyond.  Enrollees in these plans will not be affected by the new 80% MLR standard.

However, the remaining three smaller issuers that would owe rebates in 2011, Golden Rule, Coventry, and American Republic - comprising 5.4% of the market share - have MLRs of 48% to 68%.  These three smaller issuers also reported relatively high commissions, validating Iowa's concern that they may have difficulty adjusting their business models to meet an 80% standard as a result of being locked into binding multi-year agent commission and provider contracts.  Some or all of these three issuers could be impacted by meeting an 80% standard and could withdraw from the market, potentially leaving roughly 15,000 enrollees without coverage.

At the same time, the information provided in Iowa's application makes it clear that issuers can meet a higher MLR than it requested for 2011, 2012 and 2013.

Of the six issuers expected to owe rebates in 2011, five have MLRs above Iowa's requested 2011 adjustment to 60%, and three of those 5 have MLRs above 67%.

Iowa has an additional 13 issuers that cover between 300 and 1,000 lives each, and thus are not expected to owe rebates in 2011, but may become subject to rebate provisions in 2013 even if they do not grow their business.[1]  However, nine have MLRs above 75%, which is well above Iowa's requested 60% for 2011 and 70% for 2012.

For these reasons, Iowa is granted an alternative adjustment of 67% for 2011, 75% for 2012, and 80% thereafter.  This approach creates a glide path for compliance with the 80 percent standard and balances the interests of consumers, the State and the issuers in accordance with the principles underlying the MLR provision

By Senator Tom Harkin

July 26th, 2011 marks the 21stanniversary of the landmark legislation, the Americans with Disabilities Act (ADA), which helped change the lives of millions of people across the United States.  In its simplest description, the ADA improved accessibility and inclusion, and prohibited discrimination against people with disabilities. I consider passage of the ADA legislation the proudest moment of my career.

During hearings here in Washington D.C. 21 years ago, I remember listening to stories about people having to crawl up staircases on their hands and knees, being unable to go swimming or even buy a pair of shoes because of their disability. Smart, capable Americans were unable to achieve the American Dream. My late brother Frank, who lost his hearing at a very young age, was also prevented from enjoying the things in life most Americans take for granted. Today, with the help of ADA, those individuals have the necessary tools to live a full and prosperous life, unburdened by the architectural and attitudinal barriers of life before ADA.  Today with the ADA, all Americans, with or without disability, have the opportunity to fulfill their potential.

So much has changed over the last 21 years. It is hard to imagine a world without accessible entrances and restrooms, curb cuts, ramps, and a vast number of examples of universal design features that make the United States more accessible to all of its citizens. Before the passage of the ADA, people with disabilities routinely encountered physical barriers - such as stairs or not having enough room to park their specialized vehicles. Today, public buildings, sports stadiums, hotels, sidewalks, theaters, and transportation options are routinely accessible to individuals with disabilities, and auxiliary aids and services are available to provide equal access to every American.

We mark the 21stanniversary of the ADA, mindful of the significant progress that we have made to date.  The United States now has more accessible areas and activities for individuals with disabilities than anywhere else in the world. Not only has the physical world changed, but opportunity has increased dramatically and discrimination has decreased.  Americans are recognizing that every individual has the potential to make a difference and improve the nation in their own distinct way.  We continue to advance the four great goals of the ADA:  equal opportunity, full participation, independent living and economic self-sufficiency.

Tell me how the ADA has impacted your life by visiting my website at harkin.senate.gov or my Facebook page athttp://www.facebook.com/tomharkin.

A PDF version of the column is available by clicking here.

Group Will Develop Strategies to Improve the Health of Illinois Residents

CHICAGO - July 21, 2011. Governor Pat Quinn today announced 25 appointments to the State Health Improvement Plan (SHIP) Implementation Coordination Council. Today's action is the latest in a series of appointments the Governor is making as he continues to fulfill his commitment to improving the health of all Illinois residents. The interdisciplinary council is tasked with developing implementation strategies for the state's SHIP. The SHIP council will work collaboratively with the Governor's Health Care Reform Implementation Council to promote statewide improvements in public health.

Effective immediately, Governor Quinn named Joseph Antolin, Patricia Canessa, Jenifer Cartland, Greg Chance, Edwin Chandrasekar, Margaret Gadon, Cathy Grossi, Martin Hatlie, Roger Holloway, Kevin Hutchinson, Ahlam Jbara, Robert Kieckhefer, Tammy Lemke, Janine Lewis, Hong Liu, David McCurdy, Maureen McHugh, James Nelson, Sharon Post, Jose Sanchez, Clarita Santos, Patricia Schou, Terry Solomon, Janna Stansell and Christina R. Welter to the SHIP Implementation Coordination Council.

"This council brings together a diverse group of health care professionals that are leaders in their respective fields," said Governor Quinn. "We want a comprehensive approach to make sure the people of Illinois are healthy, and that means bringing everyone to the table. I look forward to the council's work, and the results they will help us achieve in public health."

The SHIP is a framework to address public health issues through an interdisciplinary approach that utilizes the strengths of the entire public health system. Under law, the state of Illinois must complete a SHIP every four years with the goal of creating a system that ensures optimal physical, mental and social well-being for all people in Illinois through a high-functioning public health system. The most recent SHIP was updated in August 2010 to reflect federal health care reform and other state health policies.

In July 2010, the Governor signed into law legislation creating a Governor-appointed council to implement the SHIP, which was one of the one of the recommendations of the SHIP planning team. The group will provide further definition of priorities and action steps, engage stakeholders to enact SHIP objectives, and promote the plan as a common agenda across the public health system.

The SHIP calls for the state to improve access to comprehensive health-related services, enhance data and information technology in the health care sectors, address the social factors affecting health and health disparities, manage and improve the public health system, and ensure sufficient workforce in the health care and public health fields. The SHIP is prevention-focused and centered on the following priority health concerns: alcohol/tobacco, use of illicit drugs/misuse of legal drugs, mental health, environment, obesity (including nutrition and physical activity), oral health, patient safety and quality, unintentional injury and violence.

In addition to the appointed council members, representatives of 12 state agencies and the chair of the State Board of Health, Dr. Javette Orgain, will participate in the SHIP Implementation Coordination Council.  These agencies all play a critical role in the implementation of the SHIP recommendations and will be working with the council to ensure that the goals of the SHIP are achieved. The council co-chairs will be appointed by the Governor.

Information regarding the new council members is attached.

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Washington, DC - Today, Congressman Bruce Braley (IA-01) released the following statement regarding the Institute of Medicine's decision supporting women's comprehensive health care:

"I commend the Institute of Medicine for their recent report supporting women's access to comprehensive health care. I have long fought for women's rights, and I believe this would be a groundbreaking step to ensure that women have full control over their reproductive lives. By requiring that health insurers provide birth control at no cost, this important action would remove major financial obstacles for women who are seeking contraceptives."

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New Law Updates Legal Protections for Citizens Helping in Emergencies

CHICAGO - July 18, 2011. Governor Pat Quinn today signed legislation to help protect good Samaritans who provide cardiopulmonary resuscitation (CPR) to a person having a heart attack or suffering cardiac arrest. Governor Quinn signed House Bill 1549, which amends the Good Samaritan Act in order to provide liability protection to individuals who are trained in CPR in accordance with either American Red Cross or American Heart Association standards.

More than 300,000 people suffer sudden cardiac arrest in the U.S. every year. According to the American Heart Association, less than 8 percent of people who suffer cardiac arrest outside the hospital survive. CPR provided immediately after sudden cardiac arrest by a trained bystander can double or triple a victim's chance of survival.

"Citizens who have been trained in CPR should not be reluctant to use their training to help another person in an emergency," said Governor Quinn. "CPR saves lives, and we want those who are able, to step up and help their fellow citizens in a crisis without fear of a lawsuit. This law protects good Samaritans and will protect lives." 

Previously, legal protections covered 'certified' rescuers; the updated law amends language so that all 'trained' rescuers are protected from lawsuits. Public confusion about who would be protected from civil liability under the Good Samaritan Act decreased the number of people willing to provide CPR to someone in emergency situations.

Updated training methods from the American Red Cross and American Heart Association focus on hands-only CPR, in which chest compressions are delivered to a victim of sudden cardiac arrest. Hands-only CPR has been shown to be as effective as traditional CPR, and is easier to master and perform than mouth-to-mouth ventilation.

House Bill 1549, sponsored by Rep. Jil Tracy (R-Quincy) and Sen. A.J. Wilhelmi (D-Joilet), was an initiative of the American Red Cross and supported by the American Heart Association. The law takes effect immediately.

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Washington, DC - Today, Congressman Bruce Braley (IA-01) announced that 20 Iowa hospitals will receive $12.5 million in additional Medicare reimbursements. The payments will be delivered to the hospitals tomorrow, and come as a result of a provision Rep. Braley authored and passed into law during the health care negotiations last Congress.

"For decades, Iowa's doctors have been punished for no reason other than geography," said Rep. Braley. "These payments are the first step toward ending these geographic disparities and reforming our Medicare system so it finally rewards quality of care instead of the number of procedures performed."

The following Iowa hospitals will receive the funds:

Hospital Name  

County  

Estimated Payment  

Broadlawns Medical Center  

Polk  

$44,991  

Grinnell Regional Medical Center  

Poweshiek  

$89,982  

Iowa Lutheran Hospital  

Polk  

$479,904  

Iowa Methodist Medical Center  

Polk  

$1,709,658  

Lakes Regional Healthcare  

Dickinson  

$74,985  

Marshalltown Medical & Surgical Center  

Marshall  

$164,967  

Mary Greeley Medical Center  

Story  

$479,904  

Mercy Hospital  

Johnson  

$509,898  

Mercy Medical Center - Cedar Rapids  

Linn  

$584,883  

Mercy Medical Center-Des Moines  

Polk  

$2,129,574  

Mercy Medical Center-North Iowa  

Cerrogordo  

$1,004,799  

Mercy Medical Center-Sioux City  

Woodbury  

$779,844  

Skiff Medical Center  

Jasper  

$104,979  

Spencer Municipal Hospital  

Clay  

$164,967  

St Anthony Regional Hospital  

Carroll  

$104,979  

St Luke's Hospital  

Linn  

$794,841

St Luke's Regional Medical Center

Woodbury

$374,925

Trinity Regional Medical Center

Webster

$434,913

Unity Hospital

Muscatine

$74,985

University Of Iowa Hospital & Clinics

Johnson

$2,399,520

TOTAL

$12,507,499

Rep. Braley secured the funding during late night negotiations with Speaker Nancy Pelosi and Obama Administration officials before the final health care votelast spring. Tomorrow, Iowa hospitals will receive $12.5 million in additional Medicare reimbursements, or 8.3 percent of the available funds. Under Rep. Braley's provision, Iowa receives the 4th-highest amount of payments of any state.

Last Congress, Braley negotiated a compromise adding language to the health carereform bill that provides an immediate $800 million to address geographic disparities for both doctors and hospitals, as well as written guarantees from Health and Human Services Secretary Kathleen Sebelius for further action toreform Medicare reimbursement rates. Iowa doctors and hospitals have long suffered from an unfair Medicare formula which reimburses them at a lower rate than providers in other states - all while offering some of the highest quality, lowest-cost care in the nation.

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