Heart on the Hill - October 2014

Heart on the Hill 

Volunteers Participate in Rally for Medical Research Hill Day

You’re the Cure advocates joined more than 300 people from 110 partnering organizations for the second annual Rally for Medical Research Hill Day in mid-September.

Heart disease and stroke survivors and caregiver volunteers from around the country came to Capitol Hill on September 17-18 to urge their members of Congress to work together to invest in the National Institutes of Health (NIH).

A congressional reception held to launch the event featured Sen. Dick Durbin (D-IL) and NIH Director Francis Collins, M.D., Ph.D. along with actress, singer and Go Red for Women spokesperson Laura Bell Bundy. Bundy shared her personal struggle with a congenital heart defect, and emphasized the need for more research to help find a less invasive treatment for herself and others with her condition.

In the weeks leading up to the event, more than 1,300 You’re the Cure advocates also helped support the association’s new “Life is Why” campaign by sharing “why” heart and stroke research was personally important to them. The volunteers who participated in the Rally Hill Day, shared their “whys” with lawmakers during their Hill visits. Advocates across the country echoed their messages by sending over 4500 messages to Capitol Hill urging lawmakers to support more funding for NIH research.

Contact: Claudia Louis

Association Releases New E-Cigarette Policy

The statement makes a number of policy recommendations in key areas of tobacco control, including: calling for federal regulation of e-cigarettes; preventing access, marketing and sales advertising to youth; and incorporating e-cigarettes into smoke-free laws.

It also examines e-cigarettes in tobacco-cessation counseling. Pointing to a lack of evidence establishing e-cigarettes as a primary smoking-cessation, the statement stresses that the association will continue to encourage clinicians to use proven smoking cessation strategies first. But the statement reiterates that when repeated efforts with conventional treatment fails, is intolerant, or rejected by a patient who wants to utilize e-cigarettes to help them quit, clinicians should not discourage their use by the patient. In addition, it calls for comprehensive and continuous research on e-cigarettes’ use, their characteristics, their marketing, and their long-term health effects on individual users, the environment and public health.

This association’s statement comes at a critical juncture for e-cigarettes as the Food and Drug Administration (FDA) is currently evaluating whether they should be regulated. In addition to soliciting public comment on the issue this past summer, the FDA recently announced that it will hold three public workshops examining e-cigarettes and public health. The series kicks-off in December with the first workshop focusing on product science; the second and third workshops will explore the impact e-cigarettes have on individual health and on the population. The association plans to participate in all three workshops.

Contact: Susan K. Bishop

FDA Urged to Regulate Lab-Developed Tests

The FDA’s lack of oversight for laboratory developed tests (LDTs) was the focus of a congressional hearing on September 9. Dr. Christopher Newton-Cheh, a cardiologist at Massachusetts General Hospital and assistant professor at Harvard Medical School, represented the association and explained to the House Commerce Health Subcommittee why the FDA should regulate the tests – particularly those that pose the highest risk to patients. newtoncheh

The number of LDTs available has grown in the last decade, moving from simple genetic tests for rare diseases to powerful, complex diagnostic tools for cancer, diabetes and cardiovascular diseases. There also has been a rise of direct-to-consumer marketing of the tests. While the FDA regulates tests sold by manufacturers as testing kits, the agency relies on “enforcement discretion” for lab-created tests, which are marketed without FDA clearance and do not require clinical studies to support their use.

During his testimony, Dr. Newton-Cheh pointed out, “As our knowledge of the genetic underpinnings of cardiovascular disease expands, we anticipate there will be many opportunities to use genetic tests to predict or preempt disease, and to treat it more effectively. However, it is imperative these tests are scientifically credible.” Some genetic tests lack scientific credibility, and without regulation, Dr. Newton-Cheh noted that there is an increased risk of undermining public and healthcare provider confidence in the use of genetic tools to improve health care.

In early October, the FDA issued a guidance document on how it plans to enforce regulations on the laboratory test market. The agency plans to phase in its authority in stages, regulating tests that pose the highest risk to patients first. Dr. Jeffrey Shuren, the FDA’s Director of the Center for Devices and Radiological Health, said this is “starting a dialogue,” and hopes to strike a balance between innovation, validity, safety and effectiveness.

The association believes that genetic tests, including LDTs, should be required to undergo independent review to confirm their analytic and clinical validity and that this information should be made available to healthcare professionals and the public. “Advanced diagnostics hold tremendous promise for patients, but the increasingly pivotal role of these diagnostics in patient care makes it imperative that their safety and effectiveness is assured by the FDA prior to use,” Newton-Cheh said in his testimony. “The FDA standards are intended to reassure patients and providers on the reliability and usefulness of diagnostic tests and set clear parameters for developers of new tests.”

Contact: Kevin Kaiser

FDA Issues Action Plan for Clinical Trial Diversity

The American Heart Association applauded the FDA for its late August release of an “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data.” The plan identifies almost 30 specific steps the FDA plans to take to increase the number of women, minorities and seniors who participate in clinical trials, and make their data and information more transparent and publicly available.

“Gender, race and age play a decisive role in how heart disease, stroke and other forms of cardiovascular disease affect us. Yet, these key populations are often left out of the research necessary to better understand the diverse impact of these diseases,” said CEO Nancy Brown in a joint press release from the association and its partners in response to the Action Plan. “That’s why the FDA must not allow this new plan to just gather dust on a shelf. It’s critical that these actions be carried out rapidly and aggressively, and we look forward to working with the FDA to implement this plan.”

Contact: Stephanie Mohl

Volunteer Testifies on Telestroke

On September 16, Dr. Ralph Sacco, association past president and chairman of neurology at the University of Miami Miller School of Medicine, participated in “Harnessing the Power of Telehealth: Promises and Challenges,” a roundtable hosted by the U.S. Senate Special Committee on Aging.

In his remarks, Dr. Sacco shared how expanding the use of telestroke has proven effective in improving the quality of care and reducing disability for stroke patients. He specifically urged senators to eliminate a barrier to the use of telestroke by allowing Medicare to provide reimbursement for telestroke consultations on behalf of Medicare stroke patients living in urban and suburban areas.

Contact: Stephanie Mohl

FDA Examines the Confidentiality of Interim Trial Data - Association Testifies

Volunteer Matt Roe, M.D., M.H.S. represented the association before a public hearing convened by the Food and Drug Administration (FDA) on August 11. The hearing was called by the agency to examine when interim results in cardiovascular outcomes safety trials should be kept confidential. The FDA was interested in learning about the effects of disclosing information from an ongoing post-market trial and whether general information about the trial could be disclosed without significant risk to the integrity of the trial or its completion.

In his remarks, Dr. Roe discussed different options for evaluating new drugs with cardiovascular safety concerns, the potential risks associated with releasing detailed interim data, and the expanded role Data and Safety Monitoring Boards can play. He suggested that creative approaches are needed to find solutions that protect the integrity and conduct of cardiovascular outcomes trials.

Dr. Roe is an associate professor of Medicine at Duke University, Faculty Director of the Global Outcomes Commercial Megatrials group, and the Duke Clinical Research Institute Fellowship Program Director.

Contact: Susan K. Bishop

Study on Network Adequacy Examines Coverage for Stroke

A new study commissioned by the association and conducted by Avalere Health found that the inclusion of specialty physicians and comprehensive stroke centers (CSC) in marketplace health plans varies widely from region to region.

Released on September 26 at an Alliance for Health Reform briefing on Network Adequacy, the study found that seven of the 30 plans reviewed (23 percent) did not include a CSC in their network; inclusion of specialty physicians ranged from eight percent to 83 percent. It also revealed that while the Affordable Care Act (ACA) includes a number of provisions intended to ensure consumers have access to the care they need, more work remains to be done.

“This study points to the need for tougher network access standards, greater transparency and more up-to-date directories of health care professionals,” said Stephanie Mohl, senior government relations advisor for the association, in a press release. “Consumers need to keep in mind the tradeoffs they may have to make between premium cost and plan coverage when they shop around for health care insurance.”

The association is currently playing an active role in the National Association of Insurance Commissioners’ efforts to update its Managed Care Network Adequacy Model Act, which was approved in 1996.

Contact: Stephanie Mohl

Affordable Care Act Update

Open enrollment for the Health Insurance Marketplaces begins November 15 and will end on February 15, 2015. The association continues to help educate Americans who need insurance about their new coverage choices and provide staff and volunteers with the information and tools they need to assist in outreach.

Here are some ACA highlights:

  • We are in the process of updating the materials in our “Covering All Americans Toolkit” to help staff and volunteers educate the public about the Marketplaces and the coverage options available to the more than 30 million Americans who remain uninsured. More information will be sent out closer to the start of open enrollment.
  • Auto-enrollment: On September 2, the Centers for Medicare & Medicaid Services (CMS) finalized its policy for consumers who are currently enrolled in Marketplace coverage to renew their coverage. As a general rule, consumers who take no action will be auto-enrolled next year into the same plan, with the same premium tax credit and cost-sharing assistance, if applicable, as they had in 2014. Consumers covered through the federally-facilitated Marketplace will receive notices shortly before open enrollment begins that explain the auto-enrollment process and encourage them to return to the Marketplace to shop for the plan that best fits their needs.
  • Lower premiums: A study released by the Kaiser Family Foundation September 5 analyzed the 2015 premiums for marketplace health plans for individuals in 15 states and the District of Columbia. It found that, on average, premiums will be slightly less in 2015 than they were this year. The analysis is based on 16 markets where states have publicly released comprehensive data on rates or rate filings for all insurers. As a result, the overall picture could change as more premium data becomes available. Nevertheless, modest increases and even decreases in premiums in these markets bodes well for consumers, given that in the past individual insurance plan premiums often rose by double-digits annually.
  • Greater choice: A report released by the Department of Health and Human Services September 23 found that there will be more choice for consumers and greater competition among insurers in 2015 in both state-based marketplaces and the federally-facilitated Marketplace. The report found that 77 insurers will be newly offering coverage in 2015. The federal Marketplace states alone will have 57 more issuers in 2015, a 30 percent net increase over this year, and the eight state-based marketplaces where data was available will have a total of six more issuers in 2015, a ten percent net increase over this year.
  • Less uncompensated care: The Department of Health and Human Services released a report on September 24, which projected that hospitals will save $5.7 billion this year in uncompensated care costs because of the Affordable Care Act. States that have expanded Medicaid will receive about 74 percent of the total savings nationally, compared to states that have not expanded Medicaid.

Contact: Stephanie Mohl

Association Leader Speaks on School Nutrition Standards

Dr. Eduardo Sanchez, deputy medical officer for the association, was one of the keynote luncheon speakers at the United Fresh Produce’s Washington conference last month. In his presentation, he stressed that children now eat more fruits and vegetables in school than ever before thanks to the new nutrition standards in the National School Lunch Program. He also reminded the 500 produce industry leaders in attendance that eating habits are formed early in life, and that these standards can help establish lifelong healthy eating patterns.

Dr. Sanchez urged attendees to tell their members of Congress that daily fruits and vegetables as part of a balanced meal are essential to the health and academic success of our children. As a result, he said it was critical that current nutrition standards for school meals not be rolled back.

The association remains committed to stopping any provisions that would undermine the school foods nutrition standards set forth by the Healthy, Hunger-Free Kids Act of 2010. Thanks to the hard work of our advocates and partners, the agriculture appropriations bills – that contained harmful provisions – are stalled. Despite these successes, challenges remain for this issue. There is a chance of unhelpful language in a continuing resolution or omnibus when Congress returns from recess following the November election, and the bill is up for reauthorization next year.

Contact: Kristy Anderson

New Institute of Medicine President Honored

On September 9, the association sponsored a reception in Washington, D.C., to welcome Victor Dzau, M.D., the new president of the Institute of Medicine (IOM).

More than 150 individuals attended the reception to pay tribute to Dr. Dzau, including Sen. Richard Burr (R-NC), Rep. G.K. Butterfield (D-NC) Rep. David Price (D-NC), and several Hill staffers. CEO Nancy Brown kicked off the program and introduced speakers Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration; Dr. Jim Yong Kim, president of the World Bank Group; and David Rubenstein, co-founder and CEO of The Carlyle Group and chairman of the Board of Trustees at Duke University. Academy Health, the American Cancer Society Cancer Action Network, the American College of Cardiology, the Association of American Medical Colleges, Kaiser Permanente and Research!America co-sponsored the event.

Before beginning his six-year term in July, Dr. Dzau spent the last decade at Duke University, where he was chancellor for health affairs and also president and CEO of the Duke University Health System. Previously, he was Hersey Professor of the Theory and Practice of Physic (Medicine) at Harvard Medical School and also served as the chair of the department of Medicine and director of Research at Brigham and Women’s Hospital.

During a career of more than three decades, Dr. Dzau has been highly regarded as a trailblazer in translational research, health innovation, and global health care strategy and delivery. Dr. Dzau received his first research grant from the association in the early 80s, and served as a volunteer since then, holding numerous leadership positions with several of our scientific councils. He is also a past recipient of our Research Achievement Award and Distinguished Scientist Award.

Contact: Claudia Louis

Federal Government Operating on a Continuing Resolution

September 30 marked the end of the federal government’s 2014 fiscal year. The 12 FY2015 appropriations bills have yet to be signed into law, which means the federal government – including priority programs for the association like the National Institutes of Health – is operating under a continuing resolution through December 11 at FY2014 levels.

Depending on the outcome of the mid-term elections, it is likely that the 12 individual bills may be included in one single “omnibus” appropriation bill. The bill will then need to be passed by Congress and ultimately signed into law by President Obama. Final funding decisions may be curtailed until March of 2015 after the new Congress takes office.

Contact: Claudia Louis

Association Makes Recommendations on CV Polypill

On September 10, the Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee met to discuss the potential clinical utility of fixed-combination prescription drugs composed of an anti-hypertensive drug, aspirin and a statin. The drug would be administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke in patients with a history of cardiovascular disease.

Niteesh Choudhry, MD, PhD, executive director of the Center for Healthcare Delivery Sciences at Brigham and Women's Hospital and Associate Professor at Harvard Medical School, represented the association at the meeting. Dr. Choudhry discussed how a cardiovascular polypill might increase medication adherence and help reduce cardiovascular morbidity and mortality. But he cautioned that more data is needed to identify the appropriate patient population, the specific ingredients and doses that should be included, and potential safety concerns. He also highlighted the need to monitor marketing of the drug following its approval.

Contact: Susan K. Bishop

CPR Hill Training

In August, the American Heart Association and the WellPoint Foundation partnered to host two hands-only CPR training sessions for Capitol Hill staffers. Over 60 staff from the House of Representatives attended the event, which also included instruction on how to use an AED.

We have joined forces with the foundation in the past to host similar training sessions that raise awareness of hands-only CPR as a lifesaving method and increase the likelihood of people performing CPR in an emergency. This effort also includes a mobile tour which has trained more than 16,000 people since it began in June 2012.

The association and the WellPoint Foundation look forward to teaming up again later this year to offer the training for Senate staff.

Contact: Kevin Kaiser


Nevada Shows National Leadership in School Nutrition

The Nevada Department of Agriculture recently adopted a new School Wellness Policy that provides two key provisions to ensure kids grow up healthy. Under the policy, all items sold to students at schools must meet the Smart Snacks Nutrition Standard established by the U.S. Department of Agriculture. In addition, marketing of these products must be consistent with the Smart Snacks Nutrition Standards. This policy includes any oral, written or visual advertising or other promotion on school property.

The association partnered with local officials in their efforts to improve school health. The Partners for a Healthy Nevada, the Alliance for a Healthier Generation and the leadership of the Nevada Department of Agriculture also played a critical role in this monumental step forward in ensuring the health of all Nevada school children.

A poll released last month by The Pew Charitable Trusts revealed that 72 percent of parents support standards for school snacks. We applaud Nevada for being one of the first states to establish a policy that responds to this need.

The American Heart Association advocates for each state to ensure a healthy environment before, during and after school. This includes foods and beverages provided or sold by the school at breakfast, lunch and after-school programs as well as all efforts to promote or market foods and beverages on school campuses.

After two years of hard work by American Heart Association staff and volunteers, New Mexico has successfully seen the completion of rulemaking on stroke and STEMI registries. These efforts started with legislation requiring New Mexico to recognize stoke and STEMI hospital designations, and shortly thereafter, the team secured funding for the state to build a statewide database to collect patient data.

Contact: Suzette Harris

19th State Passes CPR Bill

On August 20, a new law requiring CPR training for all high school graduates was signed into law in New Jersey. As the nineteenth state to pass the CPR in schools legislation, New Jersey will add more than 90,000 students to the already 1 million be trained across the country every year.

Contact: Douglas Dunsavage

Illinois Stroke Bill Becomes Law

Illinois will now formally recognize all three levels of stroke care hospitals and require EMS authorities to produce formal transport protocol plans for stroke patients in the state.

The three tiers recognized by the state include: Acute Stroke Ready Centers, Primary Stroke Centers, and Comprehensive Stroke Centers. This three-tiered system of designated stroke care hospitals is a critical prerequisite for building an efficient, integrated, statewide network of hospitals specializing in stroke care. EMS providers throughout the state will also have to update their stroke treatment and transport protocols to ensure that possible stroke patients are identified in the field and transported accordingly. As a result, patients who suffer strokes anywhere in the state will be assured of getting the highest level of stroke care available in their area.

Contact: Douglas Dunsavage

Important Wins in the Fight Against Tobacco

District of Columbia
The District of Columbia's FY2015 budget includes a one-time $2 million appropriation for its tobacco control program, boosting local investment to a total of $2.745 million – or 25.7 percent of what the CDC recommended. This win was especially impactful since the District was spending nothing on tobacco cessation three years ago. We are working with our national and local partners on a long-term campaign to achieve CDC-recommended funding of $10.7 million, with emphasis on dedicating tobacco revenue to cessation initiatives in Washington, D.C.

In addition to the cessation appropriation, the District of Columbia's FY2015 budget includes changes to the tax code that unify tax rates on tobacco products. These changes increase the tax rate on non-cigarette tobacco products, creating parity by taxing them at the same rate as cigarettes.

Waxahachie, Texas
After a lengthy campaign, Waxahachie, Texas passed a comprehensive smoke-free ordinance by a vote of 4 to 1 on August 18, covering all public work places, restaurants and bars. The law also includes e-cigarettes in its smoke-free definition and addresses the sale of e-cigarettes to minors.

Philadelphia, Penn.
Signed into law by Pennsylvania Governor Corbett on September 24, Philadelphia’s $2 per pack cigarette tax hike became the largest single increase ever in a U.S. state or locality. The Philadelphia Health Department estimates that this measure will result in 40,000 fewer smokers and 1,000 to 2,000 fewer youth smokers in the area.

Contact: Chris Sherwin

Safe Routes to School Success in Minnesota

In 2012, Minnesotans for Healthy Kids, a broad coalition of health advocates in Minnesota, began a campaign to fund a Minnesota-based Safe Routes to School (SRTS) program. In addition to the association, the coalition included nearly 40 organizations, including the Bicycle Alliance of Minnesota, Blue Cross and Blue Shield of Minnesota, Minnesota PTA and St. Paul Promise Neighborhood.

The coalition proved to be a strong voice and a powerful presence. As a result, in 2012, the Minnesota Legislature established an SRTS program, which was left unfunded due to a state budget shortfall. In 2013, the coalition backed legislation to fund the state SRTS program. Supported by the governor and the legislature, the bill was passed and provided $500,000 on an ongoing basis every two years for non-infrastructure SRTS needs, such as planning, mapping, and training.

In 2014, funding from Voices for Healthy Kids helped support a targeted coalition campaign, to build public and legislative support for SRTS funding. Despite stiff competition for state budget dollars, the legislature approved $1 million for SRTS infrastructure spending, such as sidewalk and crosswalk construction. It also increased funding by $250,000 for non-infrastructure spending.

Contact: Tim Vaske

Media Advocacy Contacts

Retha Sherrod
Director, Media Advocacy
(202) 785-7929

Samantha Carter
Associate Communications Manager, Media Advocacy
(202) 785-7935

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