September 14, 2018
New changes from CMS may impact drug coverage
On August 29, the Centers for Medicare and Medicaid Services (CMS) issued additional guidance on the upcoming changes to Medicare Part D, which covers prescription drugs. Currently, Part D plans must cover all approved uses for the drugs on their formularies. Beginning January 1, 2020, Part D plan sponsors will be able to select which uses are covered by certain drugs. For example, Tamoxifen, a drug used to prevent breast cancer recurrence, is sometimes used to treat infertility in women; under the new rules, plans may cover only one of these uses.
CMS says the new rules will provide insurers with negotiating power, which can help lower medication costs. If one drug isn’t covered for a specific use, insurers are required to have a similar drug available for the non-covered use. However, this could limit treatment access for cancer patients if a drug their provider wants to try isn’t indicated by their insurance plan—and if it’s not on their formulary, they may be charged extremely high prices for it.
To learn more about these changes, review the press release from CMS.
FDA “unreasonably delayed” graphic warnings for cigarette packages
A federal court last week ruled the U.S. Food and Drug Administration (FDA) has until the end of September to finalize a schedule for new graphic warning labels for cigarette packages.
The FDA released an initial set of labels in 2011 after the 2009 Family Smoking Prevention and Tobacco Control Act set a requirement for graphic warning labels on the front and back of all cigarette packages. These labels haven’t been finalized due to legal action from tobacco companies to push back on the requirement. The FDA was supposed to have the warnings finalized by June 22, 2011.
In court, the FDA said they would finalize the warning labels by November 2021, a decade after the original deadline. U.S. District Judge Indira Talwani ordered the FDA to provide an expedited schedule by September 26, saying the label development process had been “unreasonably delayed.”
These labels will be a critical education tool and deterrent to tobacco use. The Prevent Cancer Foundation® joins fellow advocacy organizations in urging the FDA to finalize these labels to Stop Cancer Before It Starts!®
You can read more about the ruling here.
House considers possible repeal of indoor tanning tax
A new package of measures called the “Save American Workers Act of 2017” (H.R. 3798) made its way to the House floor this week. Along with modifications to the employer coverage mandate and tax on high-cost plans under the Affordable Care Act (ACA), the bill includes a repeal of the ten percent tax on indoor tanning services.
This tax, enacted under the ACA, has had a major public health impact in recent years. Since the tax began, the number of high school students who use indoor tanning has decreased by more than half, illustrating how effective the tax is as a deterrent for indoor tanning. Repealing this tax could increase the use of indoor tanning services, which expose the user to dangerous ultraviolet (UV) rays. People who first use a tanning bed before age 35 increase their risk of melanoma, the most dangerous type of skin cancer, by 75 percent.
The Prevent Cancer Foundation® opposes the repeal of the tax on indoor tanning services and urges Congress to vote against this measure to prevent skin cancer.
To learn more about the bill, review it here.
FDA calls e-cigarette use an “epidemic” and considers ban on all flavored products
The U.S. Food and Drug Administration (FDA) announced this week new efforts to curb the “epidemic” of e-cigarette use among youth (like popular JUUL). This summer, coordinated efforts from the FDA resulted in more than 1,300 warning letters and fines to retailers nationwide who illegally sold e-cigarette products to minors.
E-cigarette manufacturers now have 60 days to give the FDA a plan for addressing the widespread use of their products among minors and explain how the benefits to adults outweigh the risk to youth. If they don’t comply, their products may be pulled from the market by the FDA.
E-cigarette use continues to rise among kids, teens and young adults. According to the CDC, more than two million middle and high school students reported using e-cigarettes in the past 30 days in 2016, including 11.3 percent of high school students. Research shows that teens who use e-cigarettes are 30.7 percent more likely to start smoking regular cigarettes within the next 6 months.
Long-term effects of e-cigarette use are still being studied, but e-cigarettes—like conventional cigarettes—contain nicotine, which harms brain development and is highly addictive. Because e-cigarettes have so far gone unregulated by the FDA (though there are change in progress), we have no way of knowing what harmful chemicals are in them or how much is being inhaled during use. We strongly support efforts to limit the marketing of e-cigarettes to children and adolescents as a critical step in protecting their health.
Review the press release from FDA to learn more.
