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Senate approves balanced opioid package

Bill addresses abuse while preserving access for seriously ill patients

On Sept. 17, the U.S. Senate passed the Opioid Crisis Response Act with strong bipartisan support. The legislation builds off a similar opioid package passed by the House of Representatives earlier this year, and includes key provisions that:

  • Encourage the development and use of non-opioid medications
  • Improves federal support of state run prescription drug monitoring programs 
  • Increases innovative research on pain treatment
  • Encourages the safe disposal of unused opioid medications by medical professionals and hospice workersRequires the Department of Health and Human Services and the Department of Justice to conduct a study on the effects of federal and state opioid prescribing limits on patients

The American Cancer Society Cancer Action Network (ACS CAN) is supportive of many of the provisions adopted in the Senate bill and continues to call for balanced solutions that won’t erect unintended barriers to appropriate pain care for cancer patients and survivors living with chronic conditions.

A statement from Chris Hansen, president of ACS CAN, follows:

“We commend the Senate for advancing thoughtful legislation that addresses the very serious public health crisis that has arisen from the misuse and abuse of opioids. The Opioid Crisis Response Act is a promising step forward as Congress works to bolster research efforts focused on the development of non-addictive pain treatments and strengthen state-run programs aimed at reining in the abuse of opioids.

“ACS CAN continues to advocate for a balanced approach to addressing the opioid abuse epidemic that won’t create unintended consequences for cancer patients and survivors who rely on prescription medications to maintain their quality of life during and after treatment.

“We urge the Senate and House to quickly work out the differences in their respective bills and help accelerate progress against this serious public health problem."


  • FDA acknowledges youth e-cigarette crisis

    ACS CAN says the agency should use its full regulatory authority to address the problem

    Below is a statement ACS CAN issued on Sept. 13, the day the Food and Drug Administration (FDA) acknowledged that youth use of electronic cigarettes has "reached an epidemic proportion." As a result, FDA is giving several leading electronic cigarette manufacturers 60 days to produce a plan to reduce youth sales.

    The following is a statement from Chris Hansen, president of the American Cancer Society Cancer Action Network (ACS CAN):

    "Today's FDA announcement acknowledging teen electronic cigarette use as a public health epidemic is a welcome and necessary first step to addressing what FDA recognizes as a serious problem. Clearly the FDA knows who the industry culprits are in this epidemic and as such should exercise its full regulatory authority over these products rather than allow the industry to voluntarily self-correct.

    "When Congress passed the Family Smoking Prevention and Tobacco Control Act in 2009 it gave FDA the tools and authority needed to adequately regulate tobacco products and prevent youth from starting tobacco use. However, because of numerous rule-making delays and a seeming reluctance to fully assert its authority, FDA for years has repeatedly missed opportunities to keep tobacco products out of the hands of our children and we have seen e-cigarette use among youth hit epidemic levels.

    "We urge FDA to require pre-market review of all new tobacco products and prohibit the sale of all flavored tobacco products, including e-cigarettes, unless those products undergo full pre-market review. This is essential to preventing another generation of teens from becoming addicted to dangerous tobacco products."


  • Federal court orders FDA to quickly implement graphic cigarette warnings

    ​In a major victory for the nation's health and the fight against tobacco, a federal court on Sept. 5 ordered the U.S. Food and Drug Administration (FDA) to expeditiously issue a final rule requiring graphic health warnings on cigarette packs and advertising, as mandated by a 2009 federal law.

    Below is a join statement released the same day from the American Academy of Pediatrics, Massachusetts Chapter of the American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network (ACS CAN), American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative.

    "The ruling by U.S. District Judge Indira Talwani of the U.S. District Court for the District of Massachusetts was in response to a lawsuit filed in October 2016 by eight public health and medical groups and several individual pediatricians. Judge Talwani agreed with the health groups that the FDA has both "unlawfully withheld" and "unreasonably delayed" agency action to require the graphic warnings.

    Judge Talwani set a deadline of September 26, 2018, for the FDA to "provide to this court an expedited schedule for the completion of outstanding studies, the publication of the proposed graphic warnings rule for public comment, review of public comments, and issuance of final graphic warnings rule in accordance with the Tobacco Control Act."

    Today's ruling is a major victory in the fight against tobacco use, the nation's No. 1 cause of preventable death. In accordance with the court's order, we urge the FDA to quickly issue, finalize and implement a rule requiring graphic cigarette warnings. The current U.S. cigarette warnings, which are printed on the side of cigarette packs and haven't been updated since 1984, are stale, unnoticed and a major impediment to greater progress in reducing cigarette smoking. Studies around the world have shown that graphic warnings are most effective at informing consumers about the health risks of smoking, preventing children and other nonsmokers from starting to smoke, and motivating smokers to quit. Requiring graphic cigarette warnings in the U.S. will protect kids, save lives and reduce tobacco-related health care costs, which total $170 billion a year.

    The 2016 lawsuit was filed by the American Academy of Pediatrics, the Massachusetts Chapter of the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, Truth Initiative and several individual pediatricians. The plaintiffs have been represented by the legal staff of the Campaign for Tobacco-Free Kids and the Boston law firm of Anderson & Krieger LLP.

    BACKGROUND

    The 2009 Family Smoking Prevention and Tobacco Control Act required graphic warnings covering the top half of the front and back of cigarette packs and 20 percent of cigarette advertising and gave the FDA until June 22, 2011, to issue a final rule requiring such warnings. While the FDA met that deadline, the specific graphic warnings required by the FDA were struck down in August 2012 by a three-judge panel of the U.S. Court of Appeals for the D.C. Circuit, which ruled 2-1 that the proposed warnings violated the First Amendment. That ruling only applied to the specific images proposed by the FDA and did not address the law's underlying requirement.

    Ruling in a separate case in March 2012, the U.S. Court of Appeals for the Sixth Circuit upheld the law's requirement for graphic warnings, finding that this provision did not violate the First Amendment. That court found the graphic warnings "are reasonably related to the government's interest in preventing consumer deception and are therefore constitutional." The U.S. Supreme Court declined to hear a tobacco industry appeal of this ruling.

    Taken together, these two federal court decisions mean the FDA is still legally obligated to require graphic health warnings, and the agency is free to use different images than those struck down by the D.C. Circuit in 2012. The FDA stated in March 2013 that it planned to issue a new rule requiring graphic warnings, but has yet to act.

    The graphic warnings were mandated by a large, bipartisan majority of Congress, which relied on an extensive scientific record demonstrating the need for the warnings and their effectiveness. Because of this evidence, at least 122 countries now require large, graphic cigarette warnings.

    The 2012 D.C. Circuit ruling striking down the FDA's proposed warnings was based, in part, on the court's judgment that the FDA had not provided sufficient evidence that graphic warnings would reduce the number of Americans who smoke. But the evidence of the public health benefits of graphic warnings has grown even stronger since that ruling. A 2013 study based on Canada's experience with graphic warnings found that if the U.S. had implemented such warnings in 2012 as planned, the number of adult smokers in the U.S. would have decreased by 5.3-8.6 million in 2013.

    Tobacco use is the No. 1 preventable cause of death in the United States, killing more than 480,000 Americans and costing about $170 billion in health care expenses each year."

    PHOTO: The image shows cigarette warning labels in Brazil.

     




  • Patients with pre-existing conditions would remain at risk under new Senate proposal

    Texas court case to invalidate health care law could jeopardize health coverage for millions

    Arguments began Sept. 4 in the U.S. District Court case, Texas v. United States, challenging the health care law known as the Affordable Care Act. The plaintiffs argue that because Congress repealed the individual mandate's tax penalty as part of tax reform legislation, the entire law is invalid and must now be struck down, including critical patient protections around pre-existing conditions and essential health benefits.

    New legislation before Congress aims to protect patients should the plaintiffs be successful in their court challenge. The bill would prohibit health plans from charging people more or denying them coverage due to their health status or pre-existing conditions. However, it would allow plans to exclude or restrict coverage for those pre-existing conditions and charge more in premiums based on someone's age, gender or job.

    A statement on the legislation from Chris Hansen, president of the American Cancer Society Cancer Action Network (ACS CAN), follows:

    "ACS CAN is pleased lawmakers recognize the need to protect patients with pre-existing conditions given the ongoing court case. Ensuring cancer patients, survivors and all those at risk for the disease are able to obtain affordable, meaningful health coverage is essential to reducing death and suffering from cancer and other serious illnesses.

    "The bill—as currently proposed—would prohibit health plans from charging more or denying people coverage based on their pre-existing conditions or health status. While these two provisions are important, their effect would largely be negated because the bill also allows plans to exclude payment for services related to those pre-existing conditions. Meaning a cancer survivor could enroll in a plan, but the plan could exclude payment for their follow-up survivorship care or any services if the cancer recurred.  Additionally, the plans could also charge people more based on age, gender and job. 

    "Prior to the current health care law, people who needed health insurance the most often found it difficult or impossible to obtain affordable coverage. Outrageous premiums and inadequate benefit packages were often the only available options. Without access to comprehensive health coverage they could afford, patients were frequently forced to delay or forego necessary health care.

    "While well intended, the current proposal would do little to prevent patients from facing those same difficult circumstances in the future if current law is negated by the courts. Cancer patients and survivors need to be able to purchase health plans that cover the entirety of their health care needs without exclusions or exorbitant premiums. This bill is an inadequate replacement for the patient protections under threat in this court case.

    "We urge lawmakers to keep their promises to protect people with pre-existing conditions and stand ready to work with them to ensure all patients can access meaningful health care coverage." 




  • Resolution would halt short-term insurance changes and preserve patient protections

    Senator Tammy Baldwin (D-Wis.) has introduced a resolution under the Congressional Review Act that would prevent the extension and expansion of short-term limited duration health insurance plans (STLD) as allowed under a new rule from the Departments of Health and Human Services (HHS) and Treasury. The rule, which was finalized August 1, allows insurers to issue – for up to 36 months – so-called short-term health insurance plans.  Insurers can deny or charge people more for these plans based on their health status, are not required to cover essential health services, like prescription drugs, and can charge older people more than three times what they charge a younger person for the same coverage.  

    Previously, these policies were intended as "bridge" coverage to provide temporary insurance coverage for no more than three months. 

    A statement from Chris Hansen, president of the American Cancer Society Cancer Action Network (ACS CAN), follows:

    "Senator Baldwin's effort today is another avenue by which lawmakers can and should take action to protect health care coverage for cancer patients, survivors and all those with serious medical conditions.

    "The final short-term health plan rule threatens to split the insurance market and weaken critical patient protections. These short-term plans will be able to charge people more for coverage based on their pre-existing conditions or deny them coverage outright. The plans will be able to set limits on how much they'll pay for certain services or refuse to cover some services —like innovative cancer treatments or prescription drugs—all together. While this will likely result in lower monthly premiums, it will also leave enrollees with potentially inadequate health coverage if they are diagnosed with an unexpected illness like cancer. It will also make it more expensive for people who need comprehensive health insurance to afford it as healthier people are siphoned out of the market into these bare bone plans.

    "ACS CAN along with more than 100 other patient, provider and consumer groups repeatedly raised serious concerns with HHS over this rule and what it would mean for people with pre-existing and serious medical conditions. We remain alarmed at the potential damage these changes could have on the individual insurance market and to millions of American cancer patients and survivors' ability to access meaningful health coverage.

    "We urge Congress to support this resolution and take immediate action to protect patients and the insurance market. If they fail to act, we encourage states to pass state laws restricting or prohibiting these potentially damaging products. Cancer patients and survivors must have access to high-quality, affordable insurance that provides comprehensive coverage, and ACS CAN stands ready to work with all lawmakers in this effort."

  • Senate approves $2 billion increase for medical research funding

    The U.S. Senate approved an FY 2019 spending bill today that: 

    • increases funding by $2 billion for the National Institutes of Health (NIH)
    • increases funding by $190 million for the National Cancer Institute (NCI)
    • preserves current funding levels for the Centers for Disease Control and Prevention (CDC) cancer screening and early detection programs and for the CDC’s Office of Smoking and Health (OSH)
    • provides $2 million for nationwide cancer registries
    • allocates $875,000 for programs dedicated to reducing skin cancer.
    A statement from American Cancer Society Cancer Action Network (ACS CAN) President Chris Hansen follows:
    “The combined Defense and Labor, Health and Human Services, Education and Related Agencies spending bill passed by the Senate today is essential to developing promising new cancer diagnostic tests, treatments and therapies. Increases in federal funding are critical to scientific development against a disease that is expected to claim the lives of more than 600,000 Americans this year.
    “Senators Roy Blunt (R-MO) and Patty Murray (D-OR), who together lead the appropriations subcommittee, should be commended for their ongoing bipartisan effort to bolster the work of NIH and to protect funding for essential early detection programs at CDC and maintain funding for OSH. Tobacco remains the number one preventable cause of cancer and OSH leads federal efforts to reduce tobacco-related death and disease by funding activities that help prevent youth from starting to use tobacco and help adult tobacco users to quit.
    “ACS CAN is also pleased to see an additional $2 million for cancer registries at the CDC, which will be used to start tracking pediatric cancer cases as outlined in the Childhood Cancer Survivorship, Treatment, Access and Research (STAR) Act, as well as an additional $875,000 for activities aimed at reducing the incidence of skin cancer. Cases of melanoma, the mostly deadly form of skin cancer, have been on the rise for decades and skin cancer is the most commonly diagnosed cancer.
    “Research shows up to half of all cancer deaths might be prevented through eliminating tobacco use, proper diet, regular exercise, managing weight, and getting recommended preventive screenings for cancer. These important preventive efforts together with increased research are key to reducing cancer-related death and suffering.
    “We applaud the Senate’s passage of this appropriations bill  and urge the House take up and pass the Senate’s budget for FY 2019.”


  • ACS CAN: ​Allowing step therapy in Medicare Part B could erect barriers to care for cancer patients

    On August 7, the Center for Medicare and Medicaid Services (CMS) issued guidance giving Medicare Advantage plans the option of applying step therapy for physician-administered and other Part B drugs, effective January 1, 2019. Step therapy means trying less expensive options before "stepping up" to drugs that cost more.

    A statement from American Cancer Society Cancer Action Network (ACS CAN) President Chris Hansen follows:

    "ACS CAN shares the administration's goal of lowering prescription drug costs for patients. However, the details of the policy change to allow for step therapy will be important to understand the impact on cancer patient access to lifesaving therapies.

    "In some instances, utilization management tools like step therapy can create an extra hurdle for cancer patients to go through before getting the appropriate drug they need to treat their cancer. Some patients may be required to try multiple therapies before they can access the one that was prescribed by their doctor.  

    "It is imperative that any step-therapy process be accompanied by a speedy and easily understood appeals process to ensure patients don't face delays to recommended treatment that could compromise the efficacy of those therapies in treating their cancer. We are pleased CMS intends to allow beneficiaries access to an appeals and exceptions process and urge them to closely monitor the extent to which beneficiaries are seeking exemptions and appeals.

    "Going through cancer treatment is hard enough – cancer patients should not be forced to "fail first" on a drug that is known not to work for them before they are allowed to take the recommended treatment."



  • New report shows state lawmakers can do more to prevent and reduce cancer

    State lawmakers across the country are missing important opportunities to pass and implement proven legislative solutions to prevent and fight cancer, according to a report released August 9 by the American Cancer Society Cancer Action Network (ACS CAN). For interactive national and state-by-state details, as well as a full copy of the report, visit www.acscan.org/measure.

    How Do You Measure Up?: A Progress Report on State Legislative Activity to Reduce Cancer Incidence and Mortality grades states on the strength of evidence-based policies that help to prevent cancer, which kills roughly 1,670 people a day nationwide, forces patients to pay nearly $4 billion in out-of-pocket expenses every year, and in 2015 cost the country more than $80 billion in direct medical expenditures. 

    This annual snapshot of key state policies shows that many states are falling behind in their efforts to prevent cancer and promote access to health coverage. The report grades states in nine specific areas of public policy that can help fight cancer: increased access to health care coverage through Medicaid, funding for cancer screening programs, passage of quality of life (palliative care) policies, implementation of balanced pain control policies, smoke-free laws, cigarette tax levels, funding for tobacco prevention and cessation programs, coverage of tobacco cessation treatment through Medicaid programs, and prohibiting minors from using indoor tanning devices.

    "Right now, families across America are in the fight of their lives against cancer and they need all the help they can get," said Chris Hansen, president of ACS CAN. "State lawmakers have policies at their fingertips that are proven to help prevent and treat cancer—policies that could mean the difference between life and death for people in their states. By passing the cancer-fighting measures laid out in this report, lawmakers will not only be saving lives today and for years to come, they'll be reducing long-term health care costs that can be reinvested back into state economies."

    A color-coded system is used to identify how well a state is doing. Green represents the benchmark position, showing that a state has adopted evidence-based policies and best practices; yellow indicates moderate movement toward the benchmark; and red shows where a state is falling short. 

    Overall, the report found:

    • Eighteen states reach benchmarks in only two or fewer of the nine legislative priority areas
    • Thirty states and the District of Columbia measure up in just three to five of the nine areas
    • Only two states – California and Massachusetts – meet benchmarks in six or more of the nine categories
    • No state meets benchmarks in eight or nine policy areas

    Special Section: Pain policy

    Pain policy is the focus of a new special section in this year's report, which found that between 2015 and 2018 the number of state legislative proposals related to pain management and opioid issues rose from fewer than 80 proposals to more than 470—a six-fold increase. Although these policies are intended to curb the ongoing opioid abuse problem, the unintended results are making it much harder for cancer patients and survivors to access their prescribed pain treatment. The report found only four states have passed balanced pain policies that help combat opioid abuse and misuse while preserving legitimate access to pain management for cancer patients and survivors.

    "Opioid abuse is a critical public health crisis that must be addressed," Hansen said. "But state lawmakers shouldn't create barriers that prevent cancer patients and survivors from accessing their prescribed pain treatments. Many cancer patients and survivors need pain treatment to live and complete even the most basic day-to-day tasks. State lawmakers should pass balanced pain policies that curb abuse while preserving access to pain medication for the cancer patients and survivors who need it."

    Access to Health Care: Medicaid

    Access to quality health coverage has been directly linked to cancer outcomes, yet 17 states still have not increased access to their Medicaid programs to help provide more low-income Americans with comprehensive, affordable health coverage. Research shows individuals without health care coverage are more likely than those with coverage to be diagnosed with cancer at a later stage, when it is more costly and difficult to treat, and when individuals are less likely to survive. Medicaid provides a critical safety-net for more than 2.3 million Americans with a history of cancer, including one-third of all childhood cancer patients at the point of diagnosis.

    Tobacco

    Despite tobacco being the number one preventable cause of death nationwide, states continue to fall short when it comes to passing laws to prevent tobacco addiction and death. Only 25 states and the District of Columbia have implemented laws requiring 100 percent smoke-free workplaces including restaurants and bars and only three states are spending more than 50 percent of the CDC recommended funding level for their tobacco prevention and cessation programs. Furthermore, just 10 states offer the full spectrum of cessation services, including individual, group, and telephone counseling and all seven Food and Drug Administration-approved tobacco cessation medications, in their Medicaid programs.

    Quality of Life

    In 2018, three states passed legislation to increase access to and awareness of palliative care, specialized medical care that focuses on care coordination and relief from pain, stress and other symptoms of treatment for life-threatening diseases such as cancer. Palliative care alongside curative treatments can improve patient outcomes, reduce hospital readmittance and increase patient and family satisfaction. It is also shown to reduce medical costs. In total, 23 states have passed palliative care legislation.

    Indoor Tanning

    Additionally, prohibiting minors under 18 from using indoor tanning devices, which the World Health Organization classifies as carcinogenic, is a cancer prevention policy that is increasing in popularity nationwide. Currently, 17 states and Washington, D.C., have laws in place that protect young people from the risks associated with these devices (up from 15 states and the District in 2016).

    The American Cancer Society estimates that more than 1.7 million people in the United States will be diagnosed with cancer and more than 600,000 will die from the disease this year.


  • Senators introduce legislation to restrict the sale of flavored tobacco products

    ​On August 1, Senators Dick Durbin (D-Ill.) and Lisa Murkowski (R- Ala.) introduced the Stopping Appealing Flavors in E-Cigarettes for Kids Act (SAFE Kids Act), legislation that would prohibit the sale of most flavored tobacco products targeted to youth. While the Family Smoking Prevention and Tobacco Control Act of 2009 prohibited the use of flavors in cigarettes, except for menthol, flavors have flourished in other combustible, non-combustible and smokeless tobacco products in recent years, including cigars and e-cigarettes.

    E-cigarette and cigar manufacturers have sought to entice kids with a new generation of candy-flavored tobacco products. These products come in flavors like gummy bear, cotton candy, and banana smash that clearly appeal to kids, and they’re often colorfully packaged to look just like candy.

    A statement from Chris Hansen, president of the American Cancer Society Cancer Action Network (ACS CAN), regarding the introduction of the legislation follows:

    "We know that candy and fruit-flavored tobacco products are a tool Big Tobacco uses to lure our nation's youth into a lifetime of addiction. The rising trend of adolescent use of flavored tobacco products, especially in e-cigarettes and cigars, is troubling and must be addressed. We commend Senators Durbin and Murkowski for their leadership in introducing this legislation and helping protect kids from the industry's deadly marketing practices.

    "We urge Congress to move swiftly to pass this legislation. Stopping the tobacco industry from hooking another generation of Americans on their deadly products should be a top priority for lawmakers and ACS CAN looks forward to working in support of this legislation. We will also continue to press the Food and Drug Administration (FDA) to end menthol flavoring in cigarettes, which is known to play a damaging role in youth initiation of smoking."

    A government study published in JAMA found that that 81 percent of kids who have ever tried tobacco started with a flavored product, including 81 percent who have ever tried e-cigarettes and 65 percent who have ever tried cigars. Youth also cite flavors as a major reason for their current use of tobacco products.

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