Heart on the Hill - May 2016

Heart on the Hill 

FDA Issues Historic Tobacco Regulation Covering E-cigarettes and Cigars

Alternative tobacco products

On May 5, the Food and Drug Administration (FDA) released a long-awaited final rule extending its regulatory authority to all tobacco products, including e-cigarettes, cigars, hookah, pipe tobacco and dissolvables.

The final rule, which takes effect on August 8, establishes a number of new requirements for manufacturers, importers and retailers of these tobacco products, including:

  • Manufacturers will be required to register with the FDA, report product ingredients and obtain FDA approval to market new tobacco products that were not available before February 15, 2007
  •  Misleading terms such as “light,” “low" and “mild” are prohibited, unless authorized by the FDA
  •  Health warnings must be included on product packages and advertisements
  •  Online and in-person sales to individuals under age 18 are prohibited, and a photo ID is required
  •  Vending machine sales are also prohibited, unless the machine is located in an adult-only facility
  •  Distribution of free samples is not allowed.

Some of the requirements, such as barring sales to minors, take effect in 90 days. Other requirements have longer compliance deadlines, such as the ban on the use of misleading terms, which will not be enforced until one year after the final rules take effect.

In a statement, AHA CEO Nancy Brown praised the release of the rule.

The association has been a strong advocate for federal oversight of all tobacco products.  In 2014, when the FDA first proposed extending its authority over these products, AHA was one of the agency’s strongest supporters, with more than 7,800 You’re the Cure advocates sending letters of support to the FDA, in addition to the association’s own detailed comments.

The association will continue to work with the FDA as it develops future regulations for these products. The FDA has already announced that it intends to issue a separate rule that would ban candy and fruit flavorings in cigars, and we will continue to encourage the agency to extend the ban to all tobacco products, including e-cigarettes.

Contact: Susan K. Bishop

Volunteers Press for Expanded Cardiac Rehab Coverage

Volunteer-advocates with Rep. Suzanne Bonamici

Volunteer-advocates with Rep. Suzanne Bonamici (D-Oregon)

On May 17, more than a dozen American Heart Association volunteer- advocates met with over 30 Congressional offices to ask their members of Congress to support legislation (S. 488/H.R. 3355) that would allow physician assistants, clinical nurse specialists and nurse practitioners to directly supervise cardiac rehabilitation programs under Medicare.

Volunteers talked with legislators about why cardiac rehab is a vital step in the recovery process for patients who have suffered a cardiac event and asked their members of Congress to cosponsor the legislation.

You're the Cure advocates who met with senators encouraged their lawmakers to support the bill’s inclusion in a bipartisan legislative package currently being developed by the Senate Finance Committee. That package would improve health outcomes for Medicare beneficiaries with chronic illnesses.

In the House, advocates asked that it be included in any Medicare bill under consideration, including the hospital bill currently being developed by the Ways & Means Committee.

The association will continue to encourage Congress to pass this legislation, and our support is critical to making this happen this year.

Kevin Kaiser

Telestroke Fly-In Spurs Legislative Momentum

Momentum is growing in Congress in support of the Furthering Access to Stroke Telemedicine Act (FAST Act), the association’s top stroke legislative priority this year. The act would provide Medicare coverage for telestroke consultations for stroke patients cared for at urban or suburban hospitals.

FAST Act advocates at the fly-in

YTC FAST Act advocates pose for a picture at the Fly-In

On March 1, the association partnered with the American Academy of Neurology on a Fly-In in support of the bill. Thirty-four You’re the Cure (YTC) volunteer-advocates joined about 200 neurologists in nearly 300 meetings on Capitol Hill to urge lawmakers to co-sponsor the FAST Act. Since the Fly-In, an additional 40 lawmakers have signed up as co-sponsors of the bill, bringing the total number in the House and Senate to 94.

In addition, a number of leading organizations, including the AARP, the American Medical Association and the American Hospital Association, have now endorsed the inclusion of the FAST Act provision in broader Medicare legislation being developed by the Senate Finance Committee.

In another sign of support for telestroke, the association has worked with stroke survivor Sen. Mark Kirk (R-Illinois) to add telestroke language to the FY2017 Military Construction-Veterans Affairs (VA) funding bill. The language urges the VA to adopt telestroke in its medical centers and requires the agency to submit a report to Congress on the status of telestroke implementation within 90 days of enactment.

Contact: Stephanie Mohl

House CNR Bill Ignores Research

In late April, the House Education and Workforce Committee released its child nutrition bill, S. 5003, or the “Improving Child Nutrition and Education Act of 2016.” Unlike the Senate compromise legislation that received unanimous support, this bill is highly partisan and would ultimately harm children’s health.

Some of its more disturbing policies include:

  • Ignoring evidence-based processes widely accepted by the scientific community used to make nutrition recommendations;
  • Prohibiting doctors and other health and nutrition experts from participating in the nutrition recommendation process;
  • Freezing the much-needed sodium reduction standard;
  • Selectively choosing only scientific research that would support eliminating future sodium targets;
  • Creating a junk food loophole by abolishing nutrition standards for a la carte foods and fundraisers; and
  • Restricting access to free meals for thousands of low-income children by cutting the Community Eligibility Provision. For some children, this would eliminate the only healthy meal they receive each day.

American Heart Association CEO Nancy Brown sent a letter to the House of Representatives on May 13 expressing the association’s strong opposition to the bill and disappointment that the bill’s authors blatantly ignored science and 70 years of bipartisan tradition in child nutrition when writing the provisions.

The Committee brought the bill up for consideration and vote on Wednesday, May 18. It passed a on party line of 20-14.

The association is encouraging committee leadership to go back to the drawing board and craft bipartisan legislation that embraces science over politics. Doing so would allow for a conference with the Senate so that Congress can finally reauthorize these programs.

AHA Volunteer Speaks at Congressional Forum on Health Equity 

Richard T. Benson, MD, PhD, the president-elect of the American Heart Association’s Greater Washington Region Board and the Associate Medical Director of Stroke at the MedStar Washington Hospital Center in Washington, D.C., spoke at a congressional forum on health disparities in April, National Minority Health Month.

The forum, “Achieving Health Equity: The Path Forward,” was sponsored by House Energy and Commerce Committee Democrats, led by Ranking Member Frank Pallone, Jr. (D-New Jersey), in partnership with the Congressional Black Caucus (CBC), the Congressional Hispanic Caucus (CHC) and the Congressional Asian Pacific American Caucus (CAPAC).

The discussion focused on health disparities in the treatment and prevention of heart disease and stroke among racial and ethnic minorities. Cardiovascular disease accounts for nearly 40 percent of the disparity in life expectancy between black and white Americans. During the panel, Dr. Benson urged policymakers to support policies to reduce sodium content in foods, noting, “We need to make the healthy choice the right choice.”

In a press release announcing the forum, Congressman G.K. Butterfield (D-North Carolina), chair of the CBC, said: “Cancer, heart disease, diabetes and stroke are some of the most debilitating diseases to disproportionately impact minority communities. This month, we recognize the importance of addressing health inequities in minority and underserved communities. Healthier communities mean lower health costs and a more productive America.”

Contact: Stephanie Mohl  

NIH Director Francis Collins

NIH Director Dr. Francis Collins

Heart Failure Included in NIH Director’s Top Ten

In April, during separate hearings before the House and the Senate Appropriations Subcommittees on Labor, Health and Human Services, Education and Related Agencies, Dr. Francis Collins, director of the National Institutes of Health (NIH) outlined 10 health predictions for the next decade. One such prediction was that the Institutes would lead the way in developing regenerative treatments for heart failure. Dr. Collins spoke about current experiments in which early results suggest a patient’s heart could rebuild itself using his or her own iPs cells. Collins noted that such treatments could make transplant waiting lists and anti-rejection therapies obsolete. 

Contact: Claudia Louis

AHA Submits Funding Recommendations for NIH, CDC

During the first quarter of 2016, the American Heart Association submitted its 2017 funding recommendations for the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC), respectively, to the House and Senate Appropriations Subcommittees on Labor, Health and Human Services, Education and Related Agencies.

For the NIH, the AHA also provided funding recommendations for the National Heart, Lung, and Blood Institute and National Institute of Neurological Disorders and Stroke. In addition, the association provided funding recommendations for CDC’s, Division for Heart Disease and Stroke Prevention, WISEWOMAN program and Million Hearts initiative.

Senate subcommittee action could occur as early as the week of June 6, followed by House subcommittee action as early as the week of June 13.

Contact: Claudia Louis

USDA Updates Nutrition Standards for Child and Adult Day Care Centers

The U.S. Department of Agriculture (USDA) recently released updated nutrition standards for the Child and Adult Care Food Program (CACFP) -- the first major revision of the CACFP nutrition standards since the program was first created in 1968.

The CACFP provides meals to more than four million children and 120,000 adults each day in child care centers, day care homes, afterschool programs, emergency shelters and adult day care centers.

Under the new standards, meals and snacks served to CACFP participants will include a greater variety of vegetables and fruit, more whole grains and less sugar and saturated fat. Providers will be required to offer children and adults at least one whole grain-rich serving of grains per day, a vegetable or fruit at breakfast and both a vegetable and fruit (or two different vegetables) at lunch and dinner.

In addition:

  • Vegetable or fruit juice will be limited to one serving per day;
  • Flavored milk is prohibited for children under six years of age;
  • Yogurt must have 23 grams of sugar or less per six-ounce serving; and 
  • Providers are prohibited from frying foods onsite.

Meanwhile, infants may only be served breastmilk or infant formula through five months of age. Solid foods may be introduced at six months. A fruit or vegetable must be served as a snack, and no juice will be allowed.

The new standards take effect June 24, but CACFP providers have until October 1, 2017 to meet the new requirements.

  Susan K. Bishop

HELP Committee Marks Up Innovation Bills

Last month, the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) marked up and passed 19 bipartisan bills intended to foster the discovery, development and delivery of new cures and treatments for patients.

The HELP Committee advanced bills that would:

  • Support medical rehabilitation research critical to finding new ways to improve recovery from stroke;
  • Encourage research collaboration;
  • Support the promise of precision medicine; and 
  • Attract and retain top talent at the Food and Drug Administration.
Currently, the package of medical innovation legislation passed by the committee does not provide any additional funding for the National Institutes of Health (NIH).
Companion legislation known as the 21st Century Cures Act that was passed in the U.S. House of Representatives last year provided a boost of about $8.75 billion in funding to the NIH spread over a five-year period.

Senate and HELP Committee leadership hope to reach an agreement on the package of bills – including one that would provide a surge in funding for the NIH – before bringing it to the floor for consideration and debate.

The association, along with a number of patient advocacy organizations, strongly encourages the Senate to include mandatory funding for the NIH in any final legislation that comes before the full Senate.

Claudia Louis  

CMS Issues Guidance on Copays Charged by Managed Care Plans for Cardiac Rehabilitation

CMS recently issued guidance for Managed Care plans that states that plans must provide written justification for copays for cardiac rehab, intensive cardiac rehab and pulmonary rehab that exceed $50, $100 and $30, respectively.

For the past two years, the American Heart Association and Centers for Medicare and Medicaid Services (CMS) have been working together to address excessively high copays charged by some Managed Care plans for cardiac and pulmonary rehabilitation. AHA staff, along with representatives of the American Association of Cardiovascular and Pulmonary Rehabilitation, met several times with CMS to investigate cases where copays were excessive.

CMS has since reached out to plans to make them aware of the issue and discuss the high charges.

The association will continue to review plan bids this fall to see what impact the guidance had on copays. 

Contact: Kevin Kaiser


Tobacco Riders Still in Appropriations Bill

An agriculture spending bill approved by the House Appropriations Committee in April contained two harmful provisions that would limit the Food and Drug Administration’s (FDA) ability to regulate certain tobacco products. Now that FDA has issued the final deeming rule, as highlighted in our lead story, opponents of the rule will continue to advocate for these provisions to weaken FDA’s efforts to protect the public’s health.

The first provision would not allow FDA to “finalize, implement, administer, or enforce” the deeming rule unless the agency reverses the decision it made in the final rule and exemptes all “large and premium cigars.” The bill’s broad definition of these products means that a significant number of cigars would be exempted – likely including certain machine-made, flavored and inexpensive cigars that appeal to kids.

The bill also contains language that would change the “grandfather date” to exempt all e-cigarettes, cigars and other newly regulated  tobacco products on the market from an important product review requirement.

The Tobacco Control Act of 2009 requires all tobacco products introduced after February 2007 to provide information to FDA about what a tobacco product contains, how it is made, what its health risks are and how it will likely be used. This information is critical so that the agency can best protect the public’s health. Now that deeming is final, e-cigarettes, cigars, etc. are included in the definition of tobacco products and will have to go through this process as well. However, if the rider is adopted, they will no longer have to do so.

Similar language was also included in the agriculture spending bill that the House Appropriations Committee approved last summer, but the association and our partners were ultimately successful in keeping the language out of the final budget agreement.

In advance of the markup, we sent a letter to Congress with 30 other public health and medical groups opposing these policy changes, while AHA staff and volunteers made calls to key committee members.

While both provisions were ultimately still included in the bill passed by the House Appropriations Committee last month, we will continue to work to remove them as the budget process moves forward to preserve the FDA’s authority to protect the public from the dangers associated with tobacco use.

Hannah Green

Nutrition Riders Back in House Appropriations Bill

In mid-April, the House Appropriations Committee passed a $21.3 billion agriculture spending bill. The bill would spend $451 million less than FY16 and is $281 million below President Obama’s budget.
The legislation includes harmful legislative riders and report language to attack nutrition policy and nutrition science.
Some specific riders and language mirror bills from past years, including:
  • A whole grains waiver and sodium delay for school meals;
  • A delay in menu label implementation;
  • A nutrition facts panel delay because of the added sugar provision; and
  • Congressional oversight for the Food and Nutrition Services research portfolio, which challenges scientific autonomy
 There was also language that would delay the voluntary sodium targets until the sodium Dietary Reference Intakes (DRI) update is released. While the association is supportive of updating the sodium DRI, there is no reason to delay the voluntary sodium targets until that takes place. While this language started out as report language, which is less insidious, Rep. Andy Harris (R-Maryland), an M.D., proposed it as an amendment to the underlying bill during mark-up, making it mandatory. There was also an amendment during markup that would limit the USDA’s proposed rule on healthy food stocking by SNAP retailers.
The association opposes the House bill and is working to keep these kinds of harmful nutrition-related riders out of the Senate bill.

HHS Releases Clinical Trials Coverage Guidance; Other ACA Updates

The Department of Health and Human Services on April 20 released long-awaited guidance about the implementation of Section 2709 of the Affordable Care Act (ACA), which prohibits most private health plans from denying a patient’s participation in a clinical trial, and requires the insurer to cover the routine study costs for the patient.

The association has been concerned that this important patient protection, which took effect on January 1, 2014, has been at times overlooked by insurers and, as such, AHA has urged HHS to release this “Frequently Asked Questions” guidance for several years now.

The FAQ makes a number of helpful clarifications about the implementation of this provision:
  • Plans or insurers may not deny, limit or impose additional conditions on the coverage of routine patient costs for items and services furnished in connection with participation in an approved clinical trial.
  • As required by the ACA, plans must cover any items or services for patients enrolled in a clinical trial that they would otherwise cover for individuals not involved in a trial.
  • Insurers or plans cannot deny coverage for services used to diagnose or treat complications or adverse events arising from participation in a clinical trial if the plan or insurer provides coverage for those services outside of a trial.
  • Out-of-network coverage for a clinical trial should be provided if the plan or issuer otherwise covers out-of-network services.
  • "Death need not be imminent” for a disease or condition to be considered life-threatening and, therefore, an approved clinical trial.
In other ACA news:
  • HHS researchers published a study in the New England Journal of Medicine in late February estimating that 565,000 hospital readmissions have been avoided since the ACA’s Hospital Readmissions Reduction Program began. The study found that readmission rates for heart attack and heart failure dropped more sharply than readmission rates for other conditions.
  • HHS released a report in March that found that 20 million Americans, including six million young adults, have gained insurance coverage since the enactment of the ACA in 2010. 
  • On April 6, HHS released an updated version of the Summary of Benefits and Coverage. The new version includes a number of useful and consumer-friendly improvements to the form that were recommended by the association.
  • HHS on April 25 released final regulations to update patient protections for Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries enrolled in managed care plans. Among other things, the new rules require the use of network adequacy standards in Medicaid and CHIP managed care for key types of providers

Major Cities/California Raise Tobacco Age

In recent months, Chicago; San Francisco; Kansas City, Missouri; and the state of California have raised the minimum purchasing age for tobacco products to 21.

Thanks to a broad scope of coalition partners spearheading efforts in the Kansas City area, it only took a few short weeks after the public campaign launch to secure the metro’s first “Tobacco to 21” policy victory. Shortly after, the Unified Government of Wyandotte County and Kansas City, Kansas joined their neighbor in raising the tobacco sales ages to 21. Since then, additional communities on both sides of the state line have followed.

In Chicago, the city council’s decision to raise the legal purchase age for all tobacco products from 18 to 21 was part of a larger package of strict tobacco control measures, including the following:

  • Alternative tobacco products like snuff and cigarillos will begin to be taxed, putting their prices on par with cigarettes, and eliminating a cheaper tobacco alternative for kids; and
  • Use of chew and spit tobacco will be banned in all athletic venues from Wrigley Field -- home of the Chicago Cubs -- all the way down to little league stadiums.
Finally, after a long, contentious battle in California against the tobacco industry and its allies, the State Assembly and Senate in March 2016 were finally victorious in passing a package of six anti-tobacco bills. As a result of tobacco industry threats to seek a referendum on Tobacco to 21 and local tax bills, the Legislature held the bill package at the “enrolling and engrossing” desk for more than 30 days.

On May 4, 2016 Governor Jerry Brown signed five of the six bills into law, making California the second state in the country to raise its minimum sales age to 21. As the most populous state in the country, this historic passage of broad-sweeping tobacco control reforms will save countless lives and will inspire other states in the nation to move their minimum sales age of tobacco to 21.

Contact: Chris Sherwin

Utah Legislature Enhances Tobacco Cessation Services

As part of its efforts to improve Medicaid services, the Utah State Legislature recently approved enhancements to the state’s tobacco cessation services. These enhancements will ensure that all Medicaid recipients have access to both counseling and FDA-approved pharmaceutical methods for tobacco cessation at no or minimal cost sharing. These efforts will provide coverage for those most in need and will further contribute to Utah’s nation-leading low smoking rates. 
Contact: Lucy Culp

Four More States, Clark County Nevada Require CPR Training 

New Mexico, Kentucky, South Carolina and Wisconsin have passed statewide policies requiring students to be trained in CPR prior to high school graduation. A total of 31 states now require CPR in Schools, bringing the total number of students who will be trained in CPR every year to 1.8 million.

In addition to these states, Nevada’s Clark County School District (CCSD) Board of Trustees voted to approve nearly $145,000 specifically designated for instructional supplies for CPR. AHA has fought to overcome curricular and funding barriers to achieve full implementation of hands-on CPR instruction in CCSD. With support from the association’s Las Vegas Division Board, we successfully advocated for the addition of hands-only CPR to CCSD’s mandatory 8th grade and high school health curriculum and for the appropriation of funds to purchase equipment to teach these lifesaving skills. With the recently approved funding, CCSD, the fifth largest school district in the nation, will train nearly 17,000 graduates each year in CPR.

States Pass Stroke and STEMI Systems of Care Policies

West Virginia, Nebraska and Georgia recently passed legislation requiring all three tiers of stroke facilities to be recognized and that all EMS authorities develop and implement transport protocol plans for acute stroke patients. A total of 15 states and Washington, D.C. have enacted policies around stroke facility designation.

In Minnesota, Gov. Mark Dayton (D) signed legislation launching an official statewide STEMI System of Care. The new legislation authorizes the Minnesota Department of Health to designate STEMI Receiving Centers and requires all EMS services in the state to have current triage and transport protocols for STEMI patients. As a result of this success, the state’s 5.4 million residents, including more than 8,000 individuals who suffer a STEMI each year, will now be covered by these stronger and more comprehensive criteria.

Mississippi and Colorado Adopt Standards for Smart Snacks in Schools

The Mississippi Department of Education voted in February to pass Smart Snack Standards for all foods and beverages sold in Mississippi schools. The new regulation brings the state in line with federal guidelines and does not permit any exemptions for unhealthy fundraisers. With strong support from Mississippi voters (97% saying that serving nutritious foods in schools is important to ensure that children are prepared to learn and do their best, and 79% saying it is very important), state leaders agreed to prohibit fundraisers where unhealthy foods like doughnuts, pizzas and candy bars are sold. Additionally, the state is helping schools through small training grants – a much-needed investment to boost school wellness councils that support healthy school changes.

Further, after a year of working to create and implement a policy around competitive foods in Colorado, the state law now aligns with the federal law requiring all schools participating in meal programs meet federal nutrition standards. AHA staff in Colorado have also been working with the Denver Division Board of Directors, including members of the Community Plan Steering committee, to establish a partnership with the Colorado Department of Education. This partnership will support implementation of the new statewide policy as part of its Community Planning 2.0 Community Action Plan.

New Orleans and Philly Commit to Healthier Food and Beverage Procurement Standards

The “NOLA Healthy Vending and Service” campaign recently announced city-wide vending machines, cafeterias and meetings will include more healthy options for city employees and the public visiting city facilities. As a result, all vending machines will include choices with more whole grains, lower sodium options and fewer sugary drinks.

Similarly, successful efforts to improve vending procurement standards for the City of Philadelphia will result in healthier food options in vending machines under city control for more than 25,000 city employees and over 1.5 million city residents.

Colorado Adopts Policy on Early Care and Education 

Colorado recently adopted new evidence-based recommendations for physical activity, screen time and nutrition standards in all early childhood education centers in the state. AHA staff worked alongside YMCA and Healthier Colorado to gather support from the community during the comment period. The state is the first to achieve an AHA policy victory for its early care and education regulatory work. 

Fertile Ground Event Convenes Advocates for Native Health 

In early May, the AHA and the Shakopee Mdewakanton Sioux Community (SMSC) convened nearly 200 Native leaders, Native youth advocates and national philanthropic organizations to advance policy work relating to nutrition, food access and health outcomes within Native American communities.

Fertile Ground II: Growing the Seeds for Native American Health, focused on determining meaningful steps to better health outcomes in Indian Country. While participants proposed an array of potential next steps for a national movement forward, some also left with their own next steps for their respective tribe or community. For instance, four tribes are planning a tribal health summit in Kansas where Raph Wahwassuck of the Prairie Band Potawatomie Nation and Missty Lechner of the Iowa Tribe of Kansas and Nebraska will incorporate information on how development and adoption of a tribal food code can improve health and support food sovereignty.

Other event highlights included a video message from Risa Lavizzo-Mourey, president and CEO of the Robert Wood Johnson Foundation; a cooking demonstration by The Sioux Chef; an inspiring message from Notah Begay III; and a presentation from Native youth leaders on their vision for a healthier future. A full report of the conference proceedings will be published in the near future. Learn more at www.voicesforhealthykids.org/fg2

Study: Voices for Healthy Kids Campaign Effectiveness 

The American Journal of Public Health published a peer-reviewed study on the impact of Voices for Healthy Kids (VFHK) in the March 2016 issue. The study, “The Voices for Healthy Kids Campaign and US State Legislation to Prevent Childhood Obesity,” examined the first year of VFHK – a joint initiative of the American Heart Association and Robert Wood Johnson Foundation – and found that states where Voices is an active supporter are improving community health and addressing health equity through policy change.

For instance, the number of childhood obesity bills introduced and enacted increased the year after the Voices campaign began and, in states with active Voices grantees, the bill enactment rate surged. Additionally, the overall focus of the proposed legislation on health equity is promising for greater community health impact.

Over the last two years, Voices for Healthy Kids has directly supported more than 50 coalitions in 20 cities and states working to help all young people grow up at a healthy weight. For more information, here’s the 2015 Voices for Healthy Kids Progress Report: Transforming Communities, Changing Lives.



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

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

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